Shaami - Regulatory Assessment

Kenya regulatory assessment

Pathway analysis for PPB/KMEDA.

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SHAAMI KENYA REGULATORY KNOWLEDGE BASE — PPB/KMEDA
Regulator: Pharmacy and Poisons Board (PPB), transitioning to Kenya Medicines, Medical Devices and Allied Substances Authority (KMEDA)
Legal basis: Pharmacy and Poisons Act Cap 244 (1957)
Address: P.O. Box 27663-00506 Nairobi; Tel 0709770100
Website / portals: PRIMS (prims.pharmacyboardkenya.org); practice.pharmacyboardkenya.org; products.pharmacyboardkenya.org
NRA maturity: WHO Maturity Level 3 (ML3), classified 2024
Covers: All product classes regulated under the Pharmacy and Poisons Act Cap 244
Sources: PPB Guidelines 2022–2025, Reliance Guidelines (Jan 2025), Kenya Gazette 2022–2023, Pharmacy and Poisons (Amendments) Rules 2010, Shaami field intelligence, MAA Field Notes (April 2026)
Last updated: April 2026
NOTE: This knowledge base is for AI reasoning. Verify all details with PPB directly or through Shaami before submission.
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REGULATOR AND PORTALS
The Pharmacy and Poisons Board (PPB) is Kenya's National Regulatory Authority under the Ministry of Health, established under the Pharmacy and Poisons Act Cap 244 (1957). PPB is transitioning to the Kenya Medicines, Medical Devices and Allied Substances Authority (KMEDA) — transition ongoing as of 2026. WHO classified PPB at Maturity Level 3 (WHO ML3) in 2024. PPB adopted regulatory reliance in January 2020.
Portals: PRIMS (prims.pharmacyboardkenya.org) for registration; practice.pharmacyboardkenya.org for GMP/premises; products.pharmacyboardkenya.org for database.
CEO: Dr. Fred M. Siyoi. Contact: P.O. Box 27663-00506 Nairobi, Tel 0709770100.
[FIELD] KMEDA transition has NOT yet happened as of April 2026. No practical impact on applications.
[FIELD] PRIMS portal covers all product types. Foreign manufacturers must go through LAR for portal access unless they have a local registered office.
[FIELD] Best communication with PPB: in-person works best, phone calls also work, follow up with email after calls.
[FIELD] Pre-submission meetings are useful and accessible. Request with a clear agenda — no third-party consultant required.
[FIELD] PPB is responsive to compassionate use and EUA applications (proven during Covid).

LOCAL REPRESENTATIVE
LOCAL AUTHORISED REPRESENTATIVE (LAR): Any manufacturer outside Kenya MUST appoint a LAR. LAR must provide written evidence of manufacturer consent. LAR is the central communication pathway with PPB. Responsibilities: regulatory compliance, adverse event reporting, field safety corrective actions, technical file maintenance, supply chain accountability. Only ONE LAR per product line/portfolio per manufacturer. LAR must obtain licence to trade in medical devices/IVDs. Per the PPB guideline, the LAR must have exclusive distribution rights for the product.
[FIELD] The LAR market in Kenya is thin, especially for medical devices. Only a handful of companies offer LAR services without bundled distribution rights — MAA/Shaami is one of very few. Pricing depends on product attractiveness. LAR exit risk is significant (potential court cases, unresponsive partners). The "one LAR per product line" rule is not strictly enforced in practice. Negotiate LAR exit provisions upfront.
[FIELD] Exclusive distribution requirement is NOT enforced by PPB in practice. Rights can be non-exclusive. No applications have been rejected for this reason.
[FIELD] LAR transfer is quick provided you have a letter of no-objection from the company or current distributor.
[FIELD] Foreign manufacturers must go through LAR for PRIMS portal access unless they have a local registered office in Kenya.
[FIELD] Wholesale dealers licence required for PRIMS portal access — checklist recently updated. First-time registrants must understand this requirement.

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SECTION 1: MEDICINES (HUMAN)
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1.1 REGULATION & DOSSIER
Regulation: Pharmacy and Poisons Act Cap 244
Dossier format: CTD (Common Technical Document, Modules 1-5), eCTD via PRIMS portal
Stability: Zone IVb (30C/75% RH) for tropical conditions

1.2 REGISTRATION PATHWAYS
FIFO (First In First Out) — Standard pathway. Full CTD dossier.
[FIELD] Timeline for generic with NO SRA approval (full CTD): 18-24 months. Official documents do not state specific timelines.
Fast Track — for WHO-PQ products, SRA-approved products, priority diseases (HIV, malaria, TB, NTDs), Essential Medicines List products.
Fee: additional USD 2,000 on top of standard fee.
[FIELD] Fast track DOES deliver faster outcomes. Under 12 months with fast track.
[FIELD] Eligibility: no published list. Donor-supported diseases (HIV, TB, malaria) and orphan drugs typically allowed. Other drugs considered if public health need — engage PPB first to determine eligibility before paying the USD 2,000 premium.
Reliance/Abridged — for WHO-PQ or SRA-approved products. Relies on Reference Regulatory Authority (RRA) assessment reports. "Sameness of product" is the critical test — any formulation, strength, or indication differences trigger additional review.
[FIELD] Timeline for generic with WHO-PQ/SRA (reliance): 6-9 months. Delays if evaluator busy, if WHO doesn't share report in time, or if SRA report is heavily redacted (need to request unredacted version — mostly relevant for SRAs).
[FIELD] If unredacted SRA assessment reports CANNOT be provided: reliance pathway is NOT possible. Applicant will be directed to full review pathway. This is the most common blocker.
[FIELD] WHO CRP processed in practice: 6-8 months with constant follow-up.
[FIELD] Standard additional documents PPB almost always requests beyond CTD: Certificate of Pharmaceutical Product (CPP) and product sample.
[FIELD] Biowaiver allowed under certain conditions (BCS-based).

1.3 RELIANCE PATHWAYS FOR MEDICINES (Source: PPB HPT/PER/GUD/091, Jan 2025)
Route 1 — WHO Collaborative Registration Procedure (CRP): For WHO-prequalified products. Fastest route. PPB receives WHO assessment directly. Screening: 30 working days. Review: 50 working days.
Route 2 — WHO Listing/SRA (WLA): For SRA-approved products where WHO listing exists. Screening: 30 days. Assessment: 90 days. Additional: 25 days for committee.
Route 3 — Full Evaluation: For products with no SRA approval, no WHO-PQ, no recognised RRA approval. Full CTD review.
Route 4 — EAC-MRH / IGAD Joint Assessment: Regional joint assessment for East African Community.
Recognised RRAs for medicines: US FDA, EMA, Health Canada, UK MHRA, TGA (Australia), Swissmedic, WHO-PQ

1.4 FEES — MEDICINES (Kenya Gazette 2022)
Registration (imported): USD 1,000. Registration (local): USD 500.
Fast-track evaluation (imported): USD 2,000.
Renewal (imported): USD 1,000. Renewal (local): USD 500.
Drug retention fee: USD 300/year (imported and local).
Clinical trials application: USD 1,000.
GMP inspection (foreign site): USD 4,000 — this fee ALWAYS applies regardless of SRA certification. Only the on-site visit may be waived if PIC/S or WHO GMP certificate is accepted; the fee itself is still charged.
GMP inspection (local site): USD 1,000.
Donated health products: Free.

1.5 GMP FOR MEDICINES
GMP inspection of manufacturing site REQUIRED before MA application for new sites.
Apply via practice.pharmacyboardkenya.org.
For SRA/PIC/S-certified sites: on-site inspection may be waived, but the USD 4,000 fee still applies. PPB accepts PIC/S member GMP certificates, WHO prequalified site status.
For non-SRA/non-PIC/S sites (e.g. India CDSCO only): Full on-site GMP inspection by PPB. Additional travel costs (estimated USD 8,000-12,000 for flights, accommodation, per diem for 2-3 inspectors). CDSCO is NOT a recognised RRA.
[FIELD] PPB accepts WHO GMP certificate in lieu of conducting its own inspection. However, if the site has NEVER been inspected by PPB, they will plan a visit in the future after the certificate is issued.
[FIELD] Non-SRA manufacturers (India, China): automatic inspection for sites never inspected by PPB. Desk review if previously inspected, unless there has been a prior quality issue.
[FIELD] PPB arranges travel for foreign GMP inspections. Inspections to specific countries are BATCHED — multiple sites inspected per trip.
[FIELD] GMP inspection can run IN PARALLEL with MA application — not sequential. Applicant does not need to wait for GMP approval before submitting MA.
[FIELD] Indian manufacturers with only CDSCO approval face the longest pathway. No reliance route exists. Full evaluation + full GMP inspection required.

1.6 IMPORT / EXPORT
Import Permit: 2% of FOB value per invoice. Import/export of health products governed by PPB guideline CEO/EIU/GUD/051 Rev 02 (February 2026).
KEBS PVoC (Pre-Export Verification of Conformity): required for imported health supplements, cosmetics and certain medical devices; not required for most medicines (PPB handles directly) or most Class C/D devices. Process: obtain a certificate of conformity in the exporting country before shipment; KEBS-appointed inspection agents (e.g. SGS, Bureau Veritas) conduct inspection. Cost approximately 0.5% of FOB value (minimum fee applies).
[FIELD] Import permit fee is 2% of FOB value, applied per invoice. No exceptions.

1.7 VARIATIONS
Source: HPT/PER/GUD/015 Rev 4 (Jan 2024) — Medicines variations.
Medicines variations: Major (Type II), Minor (Type IB), Notification (Type IA).
[FIELD] No clear variation timelines adhered to in practice for any variation category.

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SECTION 2: MEDICAL DEVICES & IVDs (Class A-D)
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Regulation: Pharmacy and Poisons Act Cap 244, PPB Medical Devices Registration Guidelines
Classification: Risk-based (Class A-D), IMDRF-aligned
Dossier format: CSDT (Common Submission Dossier Template)
Certificate validity: 5 years (2 years in emergency use)

2.1 CLASSIFICATION
Class A (Low risk): Cotton wool, bandages, hospital beds, wheelchairs, urine collection bottles
Class B (Low-moderate): Urinary catheters, tracheal tubes, orthodontic materials, surgical gloves
Class C (Moderate-high): Contact lenses (long-term), urethral stents, ventilators, haemodialysis equipment
Class D (High risk): Pacemakers, implantable defibrillators, prosthetic heart valves, cardiovascular stents

2.2 REGISTRATION PATHWAYS FOR DEVICES
Full Evaluation — Class A: always full evaluation (no reliance pathway for Class A).
Abridged — requires approval from at least ONE recognised RRA. Class B: 60 working days. Class C: 90 working days. Class D: 90 working days.
Expedited — requires approval from TWO or more RRAs. Class C: 30 working days. Class D: 30 working days.
Immediate — requires SRA approval + 3 years on market. Class B: 14 working days. Class C: 14 working days. Not available for Class D.
[FIELD] Device Class B with CE/FDA (abridged): 2-3 months realistic. Device Class B NO RRA (full eval): also 2-3 months.
[FIELD] Device Class C/D (expedited, 3+ RRAs): max 6 months (depends on single or combined device).
[FIELD] Devices: PPB relies entirely on ISO 13485 and SRA certificates for GMP — no PPB device manufacturing audit conducted.
[FIELD] Most common reason device applications are delayed: missing stability data.
[FIELD] Device variation (Technical Change requiring PPB approval): 2-3 months. USD 200 fee confirmed.
Recognised RRAs for devices: TGA (Australia), Health Canada, US FDA, EU Notified Body (accepts both MDD and MDR CE marking), Japan MHLW/PMDA, Swissmedic, HPRA (Ireland), Saudi SFDA

2.3 FEES — MEDICAL DEVICES (Kenya Gazette 2022)
Class A registration (imported): USD 100. (local): USD 50.
Class B registration (imported): USD 200. (local): USD 50.
Class C registration (imported): USD 1,000. (local): USD 100.
Class D registration (imported): USD 1,000. (local): USD 100.
Renewal fees: Same as registration fees.
Variation (imported): USD 200. (local): USD 50.
Annual retention Class A/B: USD 50.
Annual retention Class C/D (imported): USD 300. (local): USD 50.

2.4 DEVICE DOSSIER REQUIREMENTS (CSDT)
Chapter 1: Regional admin data (LAR details, manufacturer details, device description, classification justification)
Chapter 2: Summary technical documentation (STED) — device description, essential principles checklist, design verification/validation, manufacturing info, risk analysis, clinical evidence
Chapter 3: Non-clinical studies (biocompatibility, electrical safety, EMC, sterilisation validation)
Chapter 4: Clinical evidence (clinical evaluation report, post-market clinical follow-up plan)
Labelling and IFU in English required.

2.5 SOFTWARE AS A MEDICAL DEVICE (SaMD)
PPB explicitly incorporated SaMD and AI/ML-based medical devices into the medical device regulatory framework. SaMD classified using Class A-D risk system. Classification depends on: significance of information (inform/drive/treat) and healthcare situation (critical, serious, non-serious).
[FIELD] SaMD regulation is relatively new. PPB assessors are still building capacity in this area. Pre-submission consultation recommended.

2.6 IVDs (IN VITRO DIAGNOSTICS)
Classified separately from non-IVD medical devices but under same guidelines.
Classification: Class A-D based on individual risk (rows) x public health risk (columns) matrix.
Class D IVDs: highest risk — HIV, malaria, TB, blood typing (critical public health impact).
Class A IVDs: general laboratory reagents. Listing/simplified route.
WHO-PQ pathway accepted for IVDs (reliance pathway).
CSDT format. Annual retention. 5-year validity.
Fees same as medical devices (Class A-D tiers).

2.7 IN-COUNTRY PERFORMANCE TESTING (IVDs)
MANDATORY for all IVDs. Submit samples to NQCL (National Quality Control Laboratory). IVD that fails testing will NOT be approved. Adds 2-4 months to timeline.
Also applies to: Male Latex Condoms (laboratory testing required).
[FIELD] NQCL testing does NOT add significant time to the process provided proper follow-up is done. The 2-4 month estimate is a worst case without active chasing.

2.8 NQCL TESTING FEES (Kenya Gazette Notice 5607, April 2023)
Product-specific. Common examples:
Tablets/capsules (general tests): KES 30,000-60,000.
Sterile products: KES 50,000-100,000+.
IVD performance evaluation: variable by test type.
Dissolution testing: KES 15,000-30,000 per medium.

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SECTION 3: COMPLEMENTARY / HERBAL
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3.1 HEALTH SUPPLEMENTS
Guideline: PPB HPT/PER/GUD/096, June 2025
Applies to: vitamins, minerals, amino acids, enzymes, probiotics, plant extracts for nutritional supplementation (enteral forms only).
Does NOT apply to: herbal medicines, cosmetics, food products, non-enteral routes.
Products with therapeutic claims or scheduled drug substances reclassified as medicines.
Dossier: PPB-specific supplement format (not full CTD). Includes composition, CoA, safety data, labelling, GMP evidence.
Submission via PRIMS portal.
Only nutrient function claims permitted. Therapeutic/disease claims NOT permitted. Daily intake must not exceed 200% RDA.
Fees: Imported: USD 500 new, USD 500 renewal. Local: USD 100 new, USD 100 renewal.
[FIELD] Timeline: 2-3 months realistic.
[FIELD] NO reliance pathway exists for health supplements. PPB always conducts full local evaluation.
[FIELD] Borderline classification: label claim is what PPB takes — no clear threshold or predictable line between supplement and medicine. Products with therapeutic claims get reclassified as medicines.
KEBS PVoC: Required for imported health supplements.

3.2 HERBAL / COMPLEMENTARY MEDICINES
Listed (not full registration in some cases). Requires evidence of traditional use, safety data, quality data, labelling compliance.
Fees: Traditional health products (local): USD 50 new, USD 20 renewal.
[FIELD] Timeline: 9-12 months.
[FIELD] Herbal medicines have a SEPARATE pathway from supplements with different documentation requirements.

3.3 COSMETICS / BORDERLINE PRODUCTS
Listed at PPB. KEBS PVoC required.
Fees: Imported: USD 500 new, USD 500 renewal. Local: USD 100 new, USD 100 renewal.
[FIELD] Timeline: 3-6 months.
Borderline: PPB determines product-by-product. Cosmeceuticals (therapeutic claims) often reclassified as medicines.
[FIELD] Borderline classification driven by label claims — no clear published threshold.

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SECTION 3B: BIOLOGICALS / VACCINES
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[FIELD] Biologics: reliance possible for EMA and FDA approved products — not only WHO-PQ.
For biologicals and vaccines, reliance on testing by the National Reference Laboratory or reference institutions can support marketing authorization (PPB Reliance guideline HPT/PER/GUD/091).
PPB publishes a guideline for submission of documentation for registration of human vaccines, biotherapeutic products and similar biotherapeutic (biosimilar) products, and a guideline for independent lot release of vaccines.

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SECTION 4: CLINICAL TRIALS
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Clinical trials application fee: USD 1,000 (Kenya Gazette 2022).
Clinical trial application requirements (see GUIDELINE INDEX — PPB Clinical Trials Application Checklist): registration of the trial on the Pan African Clinical Trials Registry (PACTR), the study protocol, the Investigational Medicinal Product Dossier, the investigator's brochure, the GMP certificate and Certificate of Analysis of the investigational product, evidence of GCP training, a DSMB charter, a favourable opinion from a local Ethics Review Committee, indemnity cover and participant clinical-trial insurance, and four bound hard copies.

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SECTION 5: POST-MARKET / PHARMACOVIGILANCE
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Source: HPT/PDS/VMS/GUD/054 Rev 1 (Jan 2024) — Post-Market Surveillance
Source: HPT/PDS/VMS/GUD/030 Rev 2 (Jan 2024) — Recall and Withdrawal
Adverse Event Reporting: Mandatory for all registered products. Serious events within 48 hours. Non-serious within 15 days.
Recall/Withdrawal: PPB may initiate or manufacturer-initiated. Three classes: Class I (serious health hazard), Class II (temporary/reversible), Class III (unlikely adverse health consequences).
Annual retention fees must be paid — suspension/cancellation risk if missed.
[FIELD] Room for negotiation if products have not been retained on time. Rare for PPB to actually suspend registrations due to non-retention in practice.
PSURs required for medicines.
[FIELD] PSURs are submitted but PPB review is NOT consistent.
[FIELD] Post-market surveillance: routine product sampling checks are conducted by PPB.
Field Safety Corrective Actions (FSCAs) for devices — coordinated through LAR.
Device/IVD variations (Source: HPT/PER/GUD/055 Rev 0, Jan 2022): Annual Notification (AN) — administrative changes. Interim Notification (IN) — significant changes. Variation minor (Vmin) — minor technical changes. Variation major (Vmaj) — requires new submission.

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SECTION 6: KEY TIMELINES
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KEY TIMELINES [FIELD]
- Generic medicine SRA reliance: 6-9 months. Full CTD (no SRA): 18-24 months.
- Device Class B (abridged or full): 2-3 months. Device Class C/D (expedited): max 6 months.
- Health supplements: 2-3 months. Herbals: 9-12 months. Cosmetics: 3-6 months.
- Fast track: under 12 months — it delivers.
- Deficiency letters: min 2-4 weeks, no restriction on query rounds.
- Current backlog: YES, all product types affected.
Published process targets (see GUIDELINE INDEX — PPB Marketing Authorization Pathways): screening for completeness 3 working days; scientific review of quality/safety/efficacy; final decision 15 days; Board approval 14 days; registration certificate issued within 7 days. Initial assessment 30 days under full assessment, 7 days under abridged/WHO-Listed. Indicative totals: FIFO around 24 months, Fast track around 30 days, Reliance fast-track around 90 days. Applicant response to queries within not more than 6 months.

FIELD INTELLIGENCE SUMMARY (Source: MAA Field Notes April 2026)
GMP [FIELD]
- WHO GMP accepted (but PPB will schedule future visit for uninspected sites).
- Non-SRA sites = automatic inspection. Previously inspected = desk review unless quality issue.
- Inspections batched by country. PPB arranges travel.
- GMP and MA can run in parallel — not sequential.
- Devices: PPB relies on ISO 13485/SRA only — no device GMP audit.
RELIANCE [FIELD]
- No unredacted report = no reliance pathway (directed to full review). This is the #1 blocker.
- WHO CRP works: 6-8 months with constant follow-up.
- CPP + product sample always requested as standard additional docs.
- Biologics: reliance possible for EMA and FDA (not only WHO-PQ).
- NO reliance pathway for health supplements — full local evaluation always required.
LAR [FIELD]
- Exclusive distribution NOT enforced. Rights can be non-exclusive in practice.
- LAR transfer quick with no-objection letter from company/current distributor.
- Must use LAR for PRIMS portal access unless manufacturer has local office.
- Wholesale dealer's licence required for PRIMS portal access (checklist recently updated).
- LAR exit risk remains significant — negotiate provisions upfront.
WORKING WITH PPB [FIELD]
- Pre-submission meetings: useful and accessible. Request with clear agenda.
- Best communication: in-person > phone call + follow-up email.
- PRIMS portal covers all product types.
- PPB responsive to compassionate use and EUA (proven during Covid).
- KMEDA transition has NOT happened yet — no practical impact.
- PSURs submitted but review not consistent.
- Import permit: 2% FOB per invoice, no exceptions.
- Common delay reasons: stability data (devices), lack of registration in country of origin + stability data (pharma).
- First-time registrant advice: know the wholesale dealer's licence requirements, recently updated.
BORDERLINE / CLASSIFICATION [FIELD]
- Supplement vs medicine: label claim is what PPB takes — no clear threshold line.
- Herbal medicines: separate pathway from supplements with different documentation.
- Labelling: no Kenya-specific requirements beyond standard.
REMAINING GAPS (unanswered in field notes)
- Q3.2: PPB template for statement of similarity
- Q4.1: How MAA positions as LAR without exclusive distribution
- Q4.5: LAR fee range in Kenya
- Q6.1-6.4: Class A listing, expedited vs abridged difference, NQCL practical details, SaMD experience
- Q7.4: Cosmetics reclassification practical experience
- Q8.6: KEBS PVoC countries and timeline
- Q8.11-8.12: Commercially difficult products, KEMSA procurement requirements

CONSOLIDATED FEE SCHEDULE (Kenya Gazette 2022; all fees USD unless stated)
Medicines: Registration imported USD 1,000 / local USD 500. Renewal same. Fast-track imported USD 2,000. Retention USD 300/yr.
Medical Devices: Class A imported USD 100 / local USD 50. Class B imported USD 200 / local USD 50. Class C/D imported USD 1,000 / local USD 100. Renewal same as registration. Variation imported USD 200 / local USD 50. Retention A/B USD 50/yr. Retention C/D imported USD 300/yr / local USD 50/yr.
IVDs: Same as medical devices by class.
Health Supplements: Imported USD 500 / local USD 100. Renewal same.
Cosmetics: Imported USD 500 / local USD 100. Renewal same.
Herbal (local): USD 50 new / USD 20 renewal.
GMP Inspection (foreign): USD 4,000 (always applies). GMP Inspection (local): USD 1,000.
Clinical Trials: USD 1,000.
Import Permit: 2% of FOB value per invoice.
Wholesale dealer licence: KES 30,000/year (required for LAR/PRIMS portal access).
Premises registration: KES 10,000.
Manufacturing licence: KES 5,000 per product.
Advertisement approval: KES 5,000 per product.
Pharmaceutical representative permit: KES 5,000.

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GUIDELINE INDEX — OFFICIAL SOURCES (PPB GUIDELINES & FEE SCHEDULE)
(these official documents confirm and formalise the field intelligence above)
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[OFFICIAL -- Kenya Subsidiary Legislation 2022, Health Products and Technologies Registration Rules, Second Schedule of Fees, made 8 June 2022] Registration fees (USD): health product NOT manufactured in Kenya 1,000; manufactured in Kenya 500; renewal 1,000 / 500; fast-track evaluation of an imported product 2,000; donated health products 0; Emergency Use Authorization for a medical device/IVD 2,500. Medical device registration AND renewal: Class A 100, Class B 200, Class C 1,000, Class D 1,000. Food supplement / cosmetic / borderline products: imported 500, local 100 (registration and renewal). Traditional health products (locally manufactured): registration 50, renewal/listing 20.
[OFFICIAL -- Pharmacy and Poisons (Amendment) Rules 2010, Legal Notices 191 & 192, Cap. 244] GMP audit fee: foreign manufacturing site USD 4,000, local site USD 1,000. Retention fee USD 300/year; late retention penalty USD 100; appeal of a rejected registration USD 300. Clinical trial application USD 1,000. Wholesale dealer's licence KSh 30,000/year; premises registration KSh 10,000; import permit approval charged at 2% of FOB value.
[OFFICIAL -- PPB Marketing Authorization Pathways] Three scheduling routes: FIFO, Fast track, and Expedited (Emergency Use Authorization). Process steps: screening for completeness 3 working days; scientific review of quality/safety/efficacy; final decision 15 days; Board approval 14 days; registration certificate issued within 7 days. Initial assessment is 30 days under the full-assessment pathway and 7 days under the abridged / WHO-Listed pathway. Indicative totals: FIFO around 24 months (90-day assessor target), Fast track around 30 days, Reliance fast-track around 90 days. An applicant's response to queries must be submitted within not more than 6 months.
[OFFICIAL -- PPB Guidelines on Reliance Mechanisms for Marketing Authorization of Health Products and Technologies in Kenya, HPT/PER/GUD/091 Rev 0, January 2025] Four reliance evaluation pathways: Verification, Abridged review, Joint assessment / work-sharing, and Recognition. The guideline defines reference-regulatory-authority eligibility criteria and a separate reliance framework for medical devices and IVDs; for biologicals and vaccines, reliance on testing by the National Reference Laboratory or reference institutions can support marketing authorization.
[OFFICIAL -- PPB Clinical Trials Application Checklist] A clinical trial application requires registration of the trial on the Pan African Clinical Trials Registry (PACTR), the study protocol, the Investigational Medicinal Product Dossier, the investigator's brochure, the GMP certificate and Certificate of Analysis of the investigational product, evidence of GCP training, a DSMB charter, a favourable opinion from a local Ethics Review Committee, indemnity cover and participant clinical-trial insurance, and four bound hard copies.
[OFFICIAL] Further PPB guidelines now published and held on file include: renewal and re-registration of marketing authorization; submission of documentation for registration of pharmaceutical products; variation applications for registered products; import and export of health products and technologies; registration of medical devices including IVDs; change notification for registered medical devices; regulation of medical device software (MDSW); registration of health supplements and of herbal products; the Kenya Good Manufacturing Practices Guidelines; independent lot release of vaccines; and good storage and distribution practices.
[OFFICIAL] Key PPB guideline document references (Pharmacy and Poisons Board, current versions held on file): Reliance Mechanisms for Marketing Authorization -- HPT/PER/GUD/091 Rev 0 (January 2025); Renewal of Marketing Authorization for Medicines and Vaccines -- HPT/PER/GUD/031 Rev 04 (February 2026); Import and Export of Health Products and Technologies -- CEO/EIU/GUD/051 Rev 02 (February 2026). The PPB has also published current guidelines for submission of variation applications for registered human products; change notification for registered medical devices including IVDs; submission of documentation for registration of human vaccines, biotherapeutic products and similar biotherapeutic (biosimilar) products; registration of health supplements and of herbal products; evaluation and assessment for registration; and the Kenya Good Manufacturing Practices Guidelines.
[OFFICIAL] Further PPB guideline document references: Variation Applications for Registered Medicines -- HPT/PER/GUD/015 Rev 4 (January 2024); Change Notification / Variation of Registered Medical Devices including IVDs -- HPT/PER/GUD/055 Rev 0 (January 2022); Kenya Good Manufacturing Practices Guidelines -- HPT/ISE/GMP/GUD/071 Rev 2 (October 2025). PPB also publishes a Compendium of GMP technical documents for harmonisation of medicines regulation.

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SHAAMI ZIMBABWE REGULATORY KNOWLEDGE BASE — MCAZ
Regulator: Medicines Control Authority of Zimbabwe (MCAZ)
Legal basis: Medicines and Allied Substances Control Act (Cap 15:03) — "MASCA"
Address: 106 Baines Avenue, P O Box 10559, Harare
Email: mcaz@mcaz.co.zw | Website: www.mcaz.co.zw
Portal: ZIMDIS — mandatory for all medicine registration from 27 October 2025
NRA maturity: WHO Maturity Level 3 (achieved June 2024)
Sources: MCAZ Guidelines 2005-2025, Reliance Guidelines Rev 2 March 2025, Circular 24 of 2025 (Fee Schedule Sep 2025), Lab Fee Schedule FIN 011 Rev 2 June 2023, Handover v2, Scanner April 2026
Last updated: April 2026
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REGULATOR AND PORTALS
- ZIMDIS (Zimbabwe Drug Information System) — mandatory online portal from 27 Oct 2025
- MCAZ publishes Public Assessment Reports (PARs) for clinical trials and Public Inspection Reports (PIRs) for GMP from January 2025
- Application forms: MC8 (medicines), C.M.1 (complementary medicines), MC.Con 1/2 (condoms)
- Section 75 of MASCA allows importation of unregistered medicines under special circumstances

LOCAL REPRESENTATIVE
LOCAL TECHNICAL REPRESENTATIVE (LTR): Any foreign applicant must have an LTR in Zimbabwe. The LTR facilitates communication with MCAZ and assumes legal responsibilities for the product on market.
[FIELD] No standalone LTR guideline has been published by MCAZ; the requirement and the LTR's duties are set within the medicine registration guidelines, the complementary medicines guideline (C.M.1) and the MC8 application form rather than in a dedicated document (confirmed absent from the full MCAZ document library). What is established: a foreign applicant must appoint a Zimbabwe-based LTR; the LTR holds/is the responsible party for the registration, is the sole channel for MCAZ correspondence and queries, and carries legal responsibility for the product on the market including pharmacovigilance, recalls and post-market obligations.

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SECTION 1: MEDICINES (HUMAN ALLOPATHIC)
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Dossier format: CTD (Common Technical Document) via ZIMDIS portal
QIS (Quality Information Summary) MANDATORY for all registrations, variations, reregistrations (EVRF 73)
Stability: Zone IVb (30C±2 / 65% RH±5 long-term; 40C±2 / 75% RH±5 accelerated)
Labelling: English, compliant with MASCA section 77

1.1 REGISTRATION PROCESS [OFFICIAL — from MCAZ "How to Register" page]
Step 1: Applicant completes EVR Quotation Confirmation Form, submits to adminevr@mcaz.co.zw
Step 2: MCAZ Finance issues invoice
Step 3: Payment made
Step 4: Dossier submitted with: completed MC8 form, QIS (Word format), full CTD, product samples, proof of payment
Step 5: MCAZ evaluators assess; Registration Committee considers
Step 6: Applicant notified of decision

1.2 REGISTRATION PATHWAYS [OFFICIAL — EVR/GL-04 Rev 2, March 2025]
5 pathways exist:
FULL REVIEW — required for:
- NCE not registered by any RRA
- Generic with clinical data but no RRA approval
- Biological not registered with RRA
- Fixed dose combinations not registered with MCAZ or RRA
- Major variations/line extensions not approved by RRA
ABRIDGED REVIEW — for products with prior RRA approval:
- NCE already approved by RRA
- NCE based on well-established use registered by RRA
- Generic with single API registered with RRA
- Biological/biosimilar registered with RRA
- FDCs registered with RRA
- Major variations approved by RRA
Requirements: full dossier PLUS un-redacted rapporteur assessment reports from RRAs, letter of access, reference PI, declaration of sameness, RRA correspondence
VERIFICATION REVIEW — lighter than abridged:
Requirements: full dossier + reference innovator PI approved by MCAZ + secondary reference PI from RRA
JOINT ASSESSMENT (ZAZIBONA) — SADC harmonisation:
- Centralised pathway open for EOIs July 2025–December 2026
- Positive recommendation = expedited registration (90 days) in active member states
MUTUAL RECOGNITION — being explored

1.3 REFERENCE REGULATORY AUTHORITIES (RRAs)
[OFFICIAL — EVR/GL-04] WHO List of Stringent Regulatory Authorities:
Australia (TGA), Austria, Belgium, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, United States of America
Also: WHO Prequalification (WHO PQ)
Also: Egyptian Drug Authority (EDA) — bilateral framework (EVR-RF-01, June 2023)

1.4 EDA RELIANCE PATHWAY [OFFICIAL — EVR-RF-01]
Restricted to medicines manufactured in Egypt, approved by EDA, active on Egyptian market.
Requires: MC8, QIS endorsed by EDA, CTD, cGMP from EDA (within 2 years), English labelling
Fees: Generic USD 2,500 / NCE USD 3,000 / Line extension USD 1,500
MCAZ target: 30 days for complete application

1.5 PRODUCTS NOT AUTHORISED IN COUNTRY OF ORIGIN [OFFICIAL — EVR/GL-05 Rev 1, Oct 2024]
Products not produced in Zimbabwe and not authorised in country of origin can still be registered.
Requires: declaration of non-registration with reasons, cGMP from any WHO ML3/ML4 country (within 12 months), full list of all countries where reviewed/approved.
Section 75 is a ONE-OFF emergency mechanism — applicant must still submit full dossier for standard MA.

1.6 EMERGENCY USE AUTHORIZATION [OFFICIAL — EVR/GL-01 Rev 3, March 2025]
Covers: medicines, complementary medicines, biologicals, AND medical devices.
Trigger: Minister of Health declares public health emergency via Statutory Instrument.
Timeline: 2 weeks during active emergency. Validity: 12 months or when emergency ends.
Can convert to full MA if satisfactory data submitted.

1.7 FEES — MEDICINES [OFFICIAL — MCAZ Circular 24 of 2025, effective 1 September 2025]
Three tiers: (a) imported as finished product, (b) re-labelled/repacked before sale, (c) any other case (e.g. locally manufactured).
REGISTRATION (Item 7):
(a) Imported finished product: New chemical (human) USD 3,000 / New chemical (vet) USD 2,000; Generic (human) USD 2,500 / Generic (vet) USD 1,500; Line extension (human) USD 1,500 / Line extension (vet) USD 1,000; Orphan medicine USD 750; Previously registered USD 750; Resubmission USD 1,200 / Resubmission (vet) USD 750; Re-registration USD 1,000 / Re-registration (vet) USD 600; Extension of deadline USD 1,200; Additional review cycle (unresolved issues) USD 500.
(b) Re-labelled/repacked: Human USD 1,500 / New chemical USD 1,500 / Vet USD 900; Previously registered USD 750; Resubmission human USD 750 / Re-registration USD 750; Resubmission vet USD 450 / Re-registration vet USD 300; Extension of deadline USD 1,200 / Additional review cycle USD 500.
(c) Any other case (locally manufactured): Human USD 900 / Vet USD 600; Previously registered USD 750; Resubmission locally manufactured human USD 450; Re-registration locally manufactured human USD 200; Resubmission vet USD 300 / Re-registration vet USD 200; Extension of deadline USD 1,200 / Additional review cycle USD 500.
(d) Expedited review: New chemical USD 4,500 / Generic USD 4,000 / Line extension USD 3,000; New chemical (vet) USD 3,000 / Generic (vet) USD 2,500 / Line extension (vet) USD 1,500; Extension of deadline USD 1,200 / Additional review cycle USD 500.
RETENTION (Item 8, annually): Human imported finished product USD 500 / Vet imported finished USD 300; Re-labelled/repacked human USD 300 / vet USD 200; Any other case human USD 200 / vet USD 150.
RETENTION RIGHT TO SELL UNREGISTERED (Item 9, annually): Human imported finished USD 500 / Vet or orphan imported finished USD 300; Re-labelled human USD 300 / vet USD 200.
AMENDMENTS (Item 11): Finished imported: indications USD 400, distribution USD 400, formulation USD 300, stability USD 300, manufacturer USD 300, batch data USD 300, BE/BA USD 300, promotional USD 100, other USD 250. Re-labelled: indications USD 300, distribution USD 300, formulation USD 200, stability USD 200, manufacturer USD 200, batch data USD 200, BE/BA USD 200, promotional USD 100, other USD 175. Any other: indications USD 200, distribution USD 200, formulation USD 75, stability USD 75, manufacturer USD 75, batch data USD 75, BE/BA USD 75, promotional USD 50, other USD 65. Expedited amendment (Item 11e): fees listed in (a)-(d) for that process plus 50% surcharge.
PERMITS (Items 5-6): Wholesale dealer new USD 3,500 / renewal USD 1,750; Restricted wholesale dealer new USD 500 / renewal USD 250; Sales representative new USD 120 / renewal USD 100.
OTHER FEES: Import/export unregistered s75: individual prescription USD 10, hospitals/NGOs USD 50, other wholesale USD 100. Duplicate certificate of registration: finished imported USD 100, re-labelled USD 50, other USD 50. Copy of registration certificate: finished imported USD 50, re-labelled USD 30, other USD 20. Contract manufacturing: foreign principal USD 1,500 / local USD 500. Advertisements: initial submission USD 50 / resubmission USD 40. Certificate of free sale (COFs) USD 80. Certificate of pharmaceutical product (CPP) USD 150. WHO-type GMP certificate USD 150 (must apply within 6 months of last inspection; beyond 6 months requires re-inspection). Fee for conducting hearings USD 500. Licence/permit amendment USD 30. Import authorisation amendment USD 30. Temporary licence renewal s60(7) USD 200.
PREMISES (Items 1-3): Pharmacy licence (CBD) USD 1,900 / urban USD 1,000 / rural USD 600. Manufacturer licence: sterile USD 6,000 / >3 dosage forms USD 5,000 / up to 3 forms USD 4,500 / restricted USD 3,500. Manufacturer renewal: sterile USD 4,000 / >3 forms USD 3,500 / up to 3 forms USD 3,000 / restricted USD 2,500. Inspection: manufacturer USD 1,000 / other USD 200 / expedited other USD 400 plus re-inspection costs.
NOTES (Circular 24): 1. Fees do not apply to exempted persons/institutions. 2. Laboratory fees per section 73A charged on cost recovery basis. 3. GMP inspection costs charged on cost recovery basis. 4. Inspection fees for new premises are part of the application fee. 5. Restricted pharmaceutical manufacturing = repackaging and labelling only. 6. Failed initial inspections: re-inspection attracts full inspection fee plus costs per Item 3(c). 7. Restricted wholesale dealer = not in business of wholesaling but has special permit to supply by wholesale (e.g. not for profit). 8. Incomplete applications attract amendment fees per Items 11 and 22. 9. WHO-type GMP cert (Item 26) applies within 6 months of last inspection. Beyond 6 months = re-inspection required.
[OFFICIAL — EDA pathway fees from EVR-RF-01] Generic USD 2,500 / NCE USD 3,000 / Line ext USD 1,500 (these are specific to the EDA bilateral pathway and may differ from standard Circular 24 fees)
Application fee covers initial evaluation + single lab analysis. Repeat analysis = additional fee.
GMP inspection fees separate and charged on cost recovery basis. All fees non-refundable.

1.8 BIOEQUIVALENCE / BIOWAIVERS [OFFICIAL — Biowaiver Appendix I, Rev 1 June 2009]
MCAZ follows WHO/ICH approach. BCS-based biowaiver list published (~100 medicines).
BCS Class 1 = eligible for biowaiver. BCS Class 3 = eligible with specific dissolution test.
BCS Class 2/4 = generally NOT eligible.

1.9 QIS REQUIREMENTS [OFFICIAL — EVRF 73, April 2023]
Mandatory for ALL registrations, variations, reregistrations.
Word format. Structured per CTD numbering (2.3.S drug substance, 2.3.P drug product).
Four API options: prequalification, CEP, APIMF, or full PD details.
Must be revised with each assessment data submission. Change history tracked.

1.10 GMP / MANUFACTURING
[OFFICIAL — from scan + handover]
GMP inspections conducted by MCAZ Inspections unit (Licensing & Enforcement Division).
For SRA/PIC/S-certified sites: MCAZ may accept existing certificates (verify via reliance).
For non-SRA sites: full on-site inspection may be required.
Good Storage and Distribution Practices guideline published by MCAZ.
MCAZ participates in joint SADC/Zazibona GMP inspections.
[OFFICIAL — from PVCT guidelines] MCAZ follows VICH harmonisation for vet products.
[OFFICIAL -- MCAZ/LED/GL 09 Rev 3, March 2026: Good Manufacturing Practice Guideline] MCAZ fully adopts the WHO cGMP guidelines (WHO TRS 986 Annex 2 main principles, with WHO TRS annexes for water, HVAC, sterile products, quality risk management, technology transfer and biologicals).
GMP RECOGNITION: manufacturers from ICH Stringent Regulatory Authorities (EU, USA, Australia, Canada, Japan) are EXEMPT from MCAZ GMP inspection.
GMP RELIANCE via DESK REVIEW: for a site already inspected and cleared by an SRA or under WHO Prequalification (same dosage form, block and line), MCAZ may grant GMP clearance by desk review of the SRA/WHO-PQ inspection report plus CAPA, GMP certificate, APQRs and batch records. New foreign facilities in non-SRA jurisdictions are NOT eligible for reliance; desk-review reliance applies only to routine inspections, is limited to a maximum of 2 desk reviews, and MCAZ may still require an on-site or virtual inspection.
GMP INSPECTION FEES: product-based and cost-recovery for international manufacturers -- the manufacturer emails a formal request to gmp@mcaz.co.zw with the current Site Master File and the list of products marketed (or to be marketed) in Zimbabwe so the fee is calculated to scope. Local manufacturers pay no separate inspection fee (it is built into the licensing fee); same-year re-inspection is charged per the published Fee Schedule.
NEW MANUFACTURING-PLANT LICENSING: a prospective manufacturer seeks a GMP-inspectorate review meeting from the conceptual-design stage (floor plans, personnel/material flow, HVAC zoning, water system, QC laboratory layout); the design-review agreement is valid 24 months; an on-site inspection follows a complete manufacturer's-licence application before the site is licensed.
[OFFICIAL -- MCAZ/LED/GL-09a Rev 0, effective 15 December 2025: Classification of cGMP Deficiencies] GMP deficiencies are classified Critical / Major / Other (Minor), aligned with PIC/S PI 040 and Health Canada GUI-0023. A critical deficiency triggers an interim report (normally within 72 hours of the inspection) and an immediate risk-proportionate CAPA, generally within 14-30 calendar days; possible immediate regulatory decisions include a temporary halt of manufacture or release and quarantine of affected batches.
[OFFICIAL -- MCAZ/LED/GL-06 Rev 1, March 2026: Handling of Time- and Temperature-Sensitive Pharmaceutical Products (TTSPPs)] Manufacturers/applicants supplying TTSPPs to Zimbabwe must hold transport validation for climatic zone IVa, a documented risk assessment, and a calibrated digital data logger on EACH consignment (downloadable and verifiable at the port of entry); data-logger records are retained until 1 year after the product shelf life; major temperature excursions must be reported to MCAZ.

1.11 IMPORT / EXPORT
[OFFICIAL -- MCAZ/LED/GL-12 Rev 3, September 2025: Import and Export of Registered Medicines] Importation and exportation of registered medicines in Zimbabwe is governed by the Medicines and Allied Substances Control (Import and Export of Medicines) Regulations 2008 (S.I. 57 of 2008). The guideline covers Authority-approved importers and exporters; dangerous drugs, psychotropic substances, section-75 named-patient imports and personal-use imports are handled under separate regimes.

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SECTION 2: MEDICAL DEVICES & IVDs
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[CRITICAL FINDING FROM SCAN]
MCAZ currently regulates ONLY condoms and gloves as medical devices.
Draft Medical Devices Regulations 2018 exist but are NOT yet in force.
No general device, IVD, or SaMD registration framework currently operational.
Condoms: registered per SI 183 of 2005 (amended SI 130 of 2014). Tested to ISO 4074.
Application: MC.Con 1 + MC.Con 2 forms, 1,400 sample pieces, fees.
Condom lab testing fees (FIN 011): Private sector USD 350, Public sector USD 280 (all batch sizes, excludes 15% VAT).
Glove testing: USD 150 (excludes 15% VAT).
MCAZ lab is ISO 17025 accredited for condom testing by SADCAS.
[FIELD INTELLIGENCE] Foreign manufacturers of medical devices other than condoms/gloves cannot currently register through MCAZ. The draft 2018 regulations are expected but no timeline.

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SECTION 3: COMPLEMENTARY / HERBAL
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[OFFICIAL — Complementary Medicines Guideline, ~2015/2016]
Legal basis: Medicines and Allied Substances Control (Complementary Medicines) Regulations, 2015 (SI 97 of 2015)
Scope: herbal, nutraceuticals, homeopathic, TCM, Ayurvedic, aromatherapeutic
Application form: C.M.1 (not MC8)
Dossier: Sections A-F (Admin, Product, Composition, Safety/QA, Efficacy, PMS)
Herbal: requires botanical identification, herbarium specimen, toxicity data, purity tests
Nutraceuticals: no efficacy evidence required; minimum 15% of FAO/WHO RDA per daily portion
Labelling: must include "NO APPROVED THERAPEUTIC CLAIMS" disclaimer
Distribution: Complementary Medicines Pharmacy (pharmacies only) or General Sale (health shops, supermarkets)
Prohibited ingredients: Aconitum, Aristolochia, Clematis, Cocculus, Senecio, Stephania
Prohibited indications: HIV-AIDS, diabetes, cancer, TB, hypertension, CVD, epilepsy, STIs (~30 conditions)
GMP: cGMP evidence required; MCAZ may inspect foreign sites case-by-case
Fees: three tiers by manufacturing location per Circular 24 of 2025 — same as medicines (Item 7). Imported finished: new chemical USD 3,000, generic USD 2,500. Re-labelled: human USD 1,500. Locally manufactured: human USD 900.

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SECTION 3B: BIOLOGICALS / VACCINES
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Biologicals and biosimilars are registered under the SECTION 1 medicine pathways: a biological not registered with an RRA follows Full Review; a biological/biosimilar registered with an RRA is eligible for Abridged Review (see SECTION 1.2). Emergency Use Authorization (EVR/GL-01 Rev 3) explicitly covers biologicals (see SECTION 1.6). The MCAZ GMP Guideline adopts the WHO TRS annex for biologicals (see SECTION 1.10).

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SECTION 4: CLINICAL TRIALS
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CLINICAL TRIAL FEES (Circular 24 of 2025, Item 12):
Local sponsor: human USD 2,000 / vet USD 1,000 / sub-study USD 1,000 / operational USD 1,000 / observational USD 200 / other USD 100.
Foreign sponsor: Phase I USD 5,000 / Phase II USD 4,000 / Phase III-IV USD 3,000 / vet USD 1,000 / operational USD 1,000 / BE/BA USD 500 / observational USD 200 / other USD 200.
Amendment to trial (local) USD 50 / (foreign) USD 100.
[OFFICIAL] MCAZ's Pharmacovigilance and Clinical Trials Division maintains a clinical-trials guideline suite: Guidelines for Clinical Trial Application and Authorization in Zimbabwe (MCAZ/PVCT/GL-04, January 2026); Guidelines for Good Clinical Trial Practice in Zimbabwe (MCAZ/PVCT/GL-05); and further clinical-trial guidelines MCAZ/PVCT/GL-01 and GL-02 (Rev 2, May 2024) and MCAZ/PVCT/GL-06 (Rev 3, March 2026). Advertising and promotion of registered medicines is governed by MCAZ/LED/GL-18 (Rev 2, March 2026).
MCAZ publishes Public Assessment Reports (PARs) for clinical trials from January 2025.

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SECTION 5: POST-MARKET / PHARMACOVIGILANCE
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Serious/unexpected adverse events: within 15 calendar days.
Non-serious AEs: within 28 calendar days.
QPPV (Qualified Person for Pharmacovigilance) required for all registered products.
e-PV electronic reporting portal available (external user manual published).
Product defect/recall notification guideline published.
MCAZ-SAHPRA bilateral MoU covers mutual cooperation.
MCAZ-ZAMRA MoU (June 2025) covers joint inspections, track-and-trace.
VARIATIONS [OFFICIAL — EVRF 55 Rev 1, February 2024 + EVR/GL-04]:
Annual Notifications (AN) submitted via EVRF-55 form.
Requires: EVR Quotation Confirmation, MCAZ invoice, completed EVRF-55, supporting dossier (MC8/CTD), updated QIS where affected, product samples where applicable.
Variation fees per gazetted schedule. All variations require fee payment.
Reliance pathway available for variations already approved by RRA (abridged review).
Major variations not approved by RRA = full review.

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SECTION 6: KEY TIMELINES
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EDA reliance pathway: MCAZ target 30 days for a complete application (see SECTION 1.4).
Emergency Use Authorization: 2 weeks during an active emergency; validity 12 months (see SECTION 1.6).
ZAZIBONA joint assessment: a positive recommendation leads to expedited national registration within 90 days in active member states.
GMP critical-deficiency interim report: normally within 72 hours; CAPA generally within 14-30 calendar days (see SECTION 1.10).
Adverse-event reporting: serious within 15 calendar days, non-serious within 28 calendar days (see SECTION 5).
ZAZIBONA / SADC HARMONISATION:
Zimbabwe is an active member of Zazibona (SADC harmonisation initiative).
Centralised Pathway: open for EOIs July 2025–December 2026.
Positive recommendation = expedited national review and registration within 90 days in active member states.
Joint GMP inspections conducted across 11 SADC member states.
Assessment reports from Zazibona can be relied upon by other SADC regulators.

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GUIDELINE INDEX
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MCAZ LABORATORY FEE SCHEDULE [OFFICIAL — FIN 011 Rev 2, June 2023]:
All fees in USD. All prices EXCLUDE 15% VAT. Lab fees charged on cost recovery basis per section 73A.
PHYSICAL CHARACTERISTICS: Appearance/description/colour/clarity USD 15
UNIFORMITY OF MASS: Tablets USD 20, Capsules USD 25
IDENTIFICATION: Colour test (2 or fewer reagents) USD 30, Colour test (>2 reagents) USD 40, UV-Vis USD 30, HPLC/TLC/GC/AAS/FTIR USD 50
RELATED SUBSTANCES: HPLC USD 125, TLC USD 50
UNIFORMITY OF CONTENT: HPLC/GC USD 300, Spectrophotometric (UV-Vis) USD 250
LIMIT TEST: USD 50
OPTICAL ROTATION / VISCOSITY: USD 50
DISSOLUTION: Chromatographic normal USD 250, slow release USD 300, comparative USD 400. Spectrophotometric normal USD 200, slow release USD 250, comparative USD 300. Titrimetric normal USD 200
ASSAY: Titrimetric USD 100, Chromatographic USD 175, Spectrophotometric USD 150. With extraction: titrimetric USD 150, chromatographic USD 225, spectrophotometric USD 200
OTHER TESTS: Loss on drying USD 30, pH USD 15, Refractive index USD 30, Friability USD 15, Moisture content USD 50, Hardness USD 15, Fill volume/injectability USD 15, Average weight USD 15, Melting point USD 50, Viscosity specific gravity USD 150, Specific gravity USD 15, Polarimetry USD 50
STANDARDS: TBA (to be advised)
DISINTEGRATION: USD 50
MICROBIOLOGICAL: Assay USD 300, Preservative efficacy USD 300, Contamination analysis USD 200, Sterility USD 360, Bacterial endotoxins (LAL) USD 150, Identification by Vitek USD 160, Non-sterile product examination USD 450
CONDOM TESTING: Private sector (all batch sizes) USD 350, Public sector USD 280
GLOVE TESTING: All sizes USD 150
[OFFICIAL -- MCAZ Fee Schedule] Current MCAZ fees are issued as numbered MCAZ circulars -- Circular 24 of 2025 (effective 1 September 2025), preceded by Circular 12 of 2025 and Circular 19 of 2022, with a separate 2023 Laboratory Fee Schedule -- published by MCAZ directly rather than as a single statutory gazette.
[FIELD] MCAZ publishes periodic GMP inspection metrics reports (e.g. report LET 16 covering Feb-Aug 2025: 47 inspections, 89% compliance rate, 7 critical / 496 major / 175 minor findings), indicating high regulatory transparency.
COMPARATIVE NOTES (Zimbabwe vs Kenya):
- Zimbabwe uses LTR, Kenya uses LAR (same concept, different terminology)
- MCAZ uses ZIMDIS portal; Kenya uses PRIMS portal
- Zimbabwe dossier: CTD + mandatory QIS; Kenya: CTD for medicines, CSDT for devices
- Zimbabwe has NO general medical device/IVD framework (only condoms/gloves); Kenya has full Class A-D device framework
- Zimbabwe reliance RRA list is broader (full WHO SRA list); Kenya has a shorter recognised RRA list
- Zimbabwe has EDA bilateral reliance; Kenya does not
- Zimbabwe Zazibona participation is more active (SADC member); Kenya participates via EAC-MRH
- Zimbabwe has mandatory QPPV; Kenya requires PV system but less prescriptive on qualified person
- Both use Zone IVb stability conditions

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SHAAMI NIGERIA REGULATORY KNOWLEDGE BASE -- NAFDAC
Regulator: National Agency for Food and Drug Administration and Control (NAFDAC)
Legal basis: NAFDAC Act Cap N1, Laws of the Federation of Nigeria (LFN) 2004
Address: Plot 2032, Olusegun Obasanjo Way, Zone 7, Wuse, Abuja, Nigeria
Email: nafdac@nafdac.gov.ng | Website: www.nafdac.gov.ng
Portal: NAPAMS (NAFDAC Automated Product Administration and Monitoring System)
NRA maturity: WHO Maturity Level 3 (achieved); PIC/S aligned; active AMRH participant
Director General: Prof Mojisola Christianah Adeyeye
Sources: NAFDAC Guidelines, NAFDAC Tariff 2019/2020, Medical Devices Regulations 2024, reliance and lifecycle guidelines 2024-2026, secondary sources
Last updated: April 2026
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REGULATOR AND PORTALS
- NAPAMS portal for all product submissions (online)
- NAFDAC Greenbook: database of registered drugs
- Registration valid for 5 years, renewable
- Enquiries: 0700-1-NAFDAC (0700-1-623322)

LOCAL REPRESENTATIVE
Foreign manufacturers MUST appoint a Nigerian local representative (agent). The local representative must be a Nigerian entity/person. Product registration certificates are issued in the name of the local representative. Change of local representative requires: revocation letter from manufacturer for previous agent, notarised Power of Attorney to new agent, NAFDAC notification letter.

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SECTION 1: MEDICINES (HUMAN)
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Dossier format: CTD (Common Technical Document)
Guideline: DR&R-GDL-005-03 (Registration of Imported Drug Products -- current version; see SECTION 1.5)
Stability: Zone IVb

1.1 REGISTRATION PATHWAYS
Standard Review -- Full CTD dossier. Timeline: 240 working days from acceptance for drugs.
Fast Track -- Available for priority products (WHO-PQ, SRA-approved, essential medicines). Timeline shorter but not officially specified.
WHO Collaborative Registration Procedure (CRP) -- NAFDAC participates. 90 working day target.
Minor Variations -- 168 working days for drugs.
[OFFICIAL] NAFDAC has a formal regulatory reliance policy and published Guidelines for Registration of Imported Drugs, Vaccines and IVDs under WHO Collaborative Registration Procedure (CRP). Guideline based on NAFDAC's adoption of regulatory reliance mechanism for marketing authorization decisions.
Three review types: Type 2 (abridged) for SRA-approved products, Type 3 (full) for all major applications. Priority/fast-track for unmet medical need.
[FIELD] NAFDAC abridged pathway for new active substances: median 30 days review time (significantly faster than Ghana 116 days or SAHPRA 102 days per published study).
[FIELD] NDA standard timelines: 12-18 months. Reliance mechanisms can significantly shorten this.
NAFDAC is PIC/S aligned and an active AMRH participant as of 2025.
NAFDAC Ceiling List: products on Federal Government Import Prohibition List, NAFDAC Ceiling List, or Banned formulations will NOT receive new MA applications.
NAFDAC has established relationships with US FDA, UK VET, TGA, MHRA, South Korea NRA, Saudi Arabia FDA, SAHPRA, Egypt EDA for information sharing and capacity building.
Online Training School launched October 2023 for staff capacity building.
NAFDAC retains WHO ML3 status (re-benchmarked). Med Safety App used for pharmacovigilance reporting.
Biosimilar framework exists: comparability data with reference biologics required.

1.2 DOSSIER REQUIREMENTS
- Completed NAPAMS registration form
- Notarised Declaration (Appendix 1)
- Power of Attorney from manufacturer to local agent
- Certificate of Manufacture and Free Sale (authenticated by Nigerian Embassy/High Commission)
- Certificate of Analysis
- GMP certificate (authenticated by Nigerian Embassy)
- Product labels/artwork compliant with NAFDAC labelling requirements
- Stability data (Zone IVb)
- For generics: Bioequivalence study report or biowaiver data
- For new chemical entities: Clinical trial data required
- Product samples (after permit to import registration samples is granted)
- Trademark registration (with Ministry of Industry, Trade and Investment)
[FIELD] Trademark registration is a unique Nigeria requirement not found in most other African markets.
[FIELD] Embassy authentication of documents is mandatory and can add 2-4 weeks to preparation time.

1.3 LOCAL MANUFACTURING [OFFICIAL -- DR&R-GDL-014-03, effective 20 March 2025]
Guideline for registration of drug products made in Nigeria (human and veterinary).
ICH-aligned: references Q1A(R2) stability, Q1C dosage forms, Q8(R2) pharmaceutical development, Q9 quality risk management, Q12 lifecycle management.
Dossier clearance is prerequisite before NAPAMS submission.
Local manufacturer requirements: CAC business incorporation, trademark registration (Class 5 for drugs), valid superintendent pharmacist licence (PCN), valid premises retention licence, satisfactory GMP inspection or GMP certificate for product line.
NCEs: clinical trial evidence in relevant population mandatory.
Generics: BE study report or biowaiver data submitted via CTD format on DMS. BE/biowaiver assessed by efficacy assessors.
FDCs: must prove clinical advantage over single-drug alternatives -- no FDC registered without documented scientific evidence.
Timeline: 240 working days from acceptance to registration number.
Query response deadline: 90 working days or automatic closure.
Registration valid: 5 years. Advertising permit separate.
Email: registration@nafdac.gov.ng
Directorate: Drug Registration & Regulatory Affairs (DR&R), Ground Floor, NAFDAC Office Complex, Isolo, Lagos.

1.4 RELIANCE PROCEDURE
[OFFICIAL -- NAFDAC Guidelines for Registration and Related Activities of Drugs, Vaccines and Medical Devices including IVDs using the Reliance Procedure, DR&R-GDL-035-01, effective 25 September 2025] NAFDAC now has a FORMAL published reliance pathway -- this supersedes the earlier position that only WHO-PQ / WHO CRP existed. It is an abridged pathway for products whose quality, safety and efficacy or performance have been confirmed by a Stringent Regulatory Authority (SRA) per the WHO definition: ICH members before 23 October 2015 (US FDA, European Commission, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada), and MRA-associated authorities (Australia TGA, Iceland, Liechtenstein, Norway); plus authorities NAFDAC has a reliance agreement with (WAHO, AMRH, Swissmedic MAGHP).
PROCESS (8 steps): a written Expression of Interest to the Director-General (DR&R or VBM-R&RA Directorate); submission of a full CTD dossier plus complete UNREDACTED assessment reports via the dossier management system; documentation upload on the NAPAMS portal (notarised declaration, Power of Attorney valid at least 5 years or a contract-manufacturing agreement, COPP in WHO format authenticated by the Nigerian Embassy or a Commonwealth/ECOWAS country, cGMP certificate, Certificate of Analysis, trademark registration); issue of a Permit to Import samples and label vetting; Verification; Review and Assessment; Laboratory testing; and approval by the Food and Drugs Registration Committee (FDRC).
ELIGIBILITY: the product must have been registered by the SRA for MORE THAN 6 MONTHS and be the "same medical product" (same manufacturing chain, same API/FPP specifications, same product information and indications). Shared SRA assessment, inspection and audit reports must not exceed 3 years validity.
TIMELINE under reliance: NAFDAC decides on registration within 60 working days (approximately 90 calendar days).
QC LABORATORY RELIANCE: NAFDAC may rely on analytical reports from WHO-prequalified or ISO/IEC 17025-accredited laboratories, SRA-country government laboratories, and NRAs operating at WHO maturity level 3 or 4. An SRA-approved variation qualifies for an abridged variation review; a variation still pending with the SRA disqualifies the application from reliance. NAFDAC retains sovereignty and currently has NO mutual recognition agreement with any NRA for inspections.

1.5 RISK-BASED REGISTRATION, REGISTRATION / RENEWAL / VARIATION
[OFFICIAL -- NAFDAC Guidelines for Risk Categorization of Product Dossiers for the Registration of Drug Products for Human Use, DR&R-GDL-033-01, effective 7 December 2024] NAFDAC operates a risk-based registration approach with low / medium / high-risk pathways for allopathic human drugs (locally made and imported); a full product dossier is required for every product regardless of risk category. A LOW-RISK application is, for example, an already-registered product contract-manufactured by a known manufacturer, on the Nigerian market for at least 5 years, with the same active ingredient, formulation and container-closure and no failed NAFDAC survey -- it qualifies for an optimised, faster assessment pathway.
[OFFICIAL -- NAFDAC Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs), DR&R-GDL-005-03, effective 20 March 2025] The core guideline for registering imported human and veterinary drug products; products on the Federal Government Import Prohibition List or the NAFDAC Ceiling List are not entertained.
[OFFICIAL -- NAFDAC Guidelines for Renewal of Certificate of Registration for Drug Products (Human and Veterinary), DR&R-GDL-025-04, effective 20 December 2024] A drug-product Certificate of Registration is valid 5 years and must be renewed to keep the product on the Nigerian market.
[OFFICIAL -- NAFDAC Guidelines on Variations to a Registered Pharmaceutical Product, DR&R-GDL-019-02, effective 29 August 2024] Post-approval changes are classified by reporting type: Notification, Minor variation (Vmin), Major variation (Vmaj), and new/extension applications; each type has defined conditions to be fulfilled and required documentation.
[OFFICIAL -- NAFDAC Guidelines for Contract Manufacturing of Finished Pharmaceutical Products in Nigeria, DER-GDL-023-00, effective 3 February 2021] Governs contract-manufacturing arrangements for finished pharmaceutical products.
[OFFICIAL -- NAFDAC Guidelines on the Investigation of Bioequivalence 2025, DER-GDL-009-01, effective 5 May 2025] Sets requirements for in vivo bioequivalence and bioavailability studies in humans for generic medicines -- general BE/BA considerations, provisions for human studies, study conduct, study protocol and pharmacokinetic comparative bioavailability studies.
[OFFICIAL -- NAFDAC Guidelines for Importation of Active Pharmaceutical Ingredients, DER-GDL-022-01, effective 25 March 2026] APIs may not be imported into Nigeria unless the finished-pharmaceutical-product manufacturer, marketer, re-labeller, re-packer or end user holds a NAFDAC Permit or Authorization for the API.
[OFFICIAL] NAFDAC also operates a separate registration procedure for MSME (micro / cottage / kitchen-scale) products, with a 90-working-day timeline from application to certificate collection.

1.6 FEES -- NAFDAC TARIFF
[OFFICIAL -- NAFDAC Tariff, effective 31 January 2020. Section G: Registration]
All fees in NGN (local) or USD (foreign). Exclusive of VAT. Registration is per product.
Lab, certificate fees and import permit fees are EMBEDDED in foreign registration fees.
SECTION G: REGISTRATION (per product) -- PHARMACEUTICALS:
OTC medicines: local NGN 80,000 / foreign USD 967
POM 1 (can be manufactured in Nigeria): local NGN 80,000 / foreign USD 1,280
POM 2 (no existing local manufacturing): local NGN 80,000 / foreign USD 1,200
Orphan drugs: local NGN 80,000 / foreign USD 967
Vaccines/Biologicals: local NGN 80,000 / foreign USD 1,200
Veterinary medicines and supplements: local NGN 80,000 / foreign USD 1,200
Herbal/nutraceuticals/alternative: foreign full registration USD 1,252 / listing USD 612.63, local micro NGN 20,000, small NGN 30,000, medium/large NGN 40,000
Clinical data review (NCE): NGN 50,000
Renewal: 80% of new registration cost
Additional source/site or change of source: same as new registration fees
MEDICAL DEVICES: Medical Devices 1 (all except diapers/pads) local NGN 20,000 / foreign USD 750; Medical Devices 2 (diapers and sanitary pads) local NGN 20,000 / foreign USD 874.
COSMETICS: local micro NGN 22,000, small NGN 66,000, medium/large NGN 85,000 / foreign USD 1,252.
SECTION B: ANCILLARY FEES: Advertisement (single product) NGN 15,000; Change in brand name local NGN 27,500 / foreign USD 206.25; Change in variants (food/cosmetics) local NGN 22,000 / foreign USD 1,050; Change in variants (medicines) local NGN 22,000 / foreign USD 614.30; Change of agencyship 50% of registration cost; Package label/design/pack size extension local NGN 21,000 / foreign USD 206.25; Fast track approval DOUBLE cost of the relevant activity; PV/post-marketing annual fees 10% of registration fees; No objection approval NGN 300,000 (max 3 per year).
SECTION C: CLINICAL TRIALS: Application (local IMP) NGN 250,000; Application (imported IMP) USD 1,923; Extension of study local NGN 50,000 / foreign USD 2,747.25; Inspection local NGN 350,000 / foreign USD 5,494.51; Additional site local NGN 150,000 / foreign USD 415; Substantial protocol amendment local NGN 50,000 / foreign USD 412.09.
SECTION D: FACILITY AND PORT INSPECTIONS: Foreign pharma GMP inspection USD 10,989.01 per site (valid 3 years); Risk-based desk review (already inspected foreign sites) USD 5,000; Local pharma production (medium/large) NGN 170,000 (renewable yearly); Port inspection -- OTC drugs (per 20ft container) NGN 148,500; Port inspection -- POM/food/cosmetics NGN 40,000; Port inspection -- orphan drugs/ARVs/vaccines/biologicals/service devices NGN 13,500; Port inspection -- medical devices NGN 27,000.
SECTION E: FORMS/CERTIFICATES: Application forms NGN 2,500; cGMP certificate NGN 20,000; Certificate of Manufacture and Free Sale NGN 10,000; Certificate of Free Sale NGN 25,000.
SECTION I: LABORATORY ANALYSIS (per product): OTC drugs local NGN 54,000 / foreign NGN 297,000; POM drugs local NGN 54,000 / foreign NGN 135,000; Orphan drugs foreign NGN 13,000; Vaccines/biologicals local NGN 13,000 / foreign NGN 13,000; Medical devices (diapers) local NGN 29,700 / foreign NGN 101,250; Medical devices (other) local NGN 29,700 / foreign NGN 67,500; Cosmetics local medium/large NGN 60,000 / foreign NGN 135,000; Herbals/nutraceuticals local NGN 29,700 / foreign NGN 135,000.
NOTES: Product licences renewed every 5 years. Listing certificates renewed every 2 years. Expired registration = unregistered product. 10% of foreign registration fee is import permit processing; 80% is processing fee (attracts 5% VAT); 10% is certificate fee. POM 1 = medicines that CAN be manufactured in Nigeria. POM 2 = medicines with NO existing local manufacturing. Medical Devices 1 = all devices except diapers/pads. Medical Devices 2 = diapers and sanitary pads only.
[FIELD] All payments via bank draft. No cheque payments.

1.7 GMP REQUIREMENTS
NAFDAC conducts foreign GMP inspections. Foreign GMP inspection plan published annually.
For imported products: GMP certificate required, authenticated by Nigerian Embassy.
Manufacturing licence/certificate required (especially for India and China -- embassy authentication mandatory).
NAFDAC Strategic Plan for Risk-Based Inspection of Foreign Pharmaceutical Manufacturing Facilities published.
WHO GMP, PIC/S GMP, US FDA cGMP, EU GMP accepted.
[FIELD] NAFDAC batches foreign inspections by region. India/China inspections prioritised due to volume.

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SECTION 2: MEDICAL DEVICES & IVDs
==============================================================
Regulation: NAFDAC Medical Devices and Related Products (Registration, Labelling and Advertisement) Regulations, 2024 (gazetted)
Classification: 4 classes (Class I low risk to Class IV high risk) -- IMDRF aligned
Guideline: R&R-GDL-OO8-O2 (Registration of Medical Devices in Nigeria)
Registration valid: 5 years

2.1 REGISTRATION PROCESS
Step 1: Appoint local agent
Step 2: Trademark registration (mandatory)
Step 3: Submit documentation via NAPAMS: Evidence of business incorporation, trademark registration, fee payment, CoA, manufacturing agreement, GMP/inspection report, product labels, device details
Step 4: For foreign manufacturers: notarised declaration, Power of Attorney, Free Sale Certificate (FSC), current GMP, letter of invitation for GMP inspection
Step 5: Laboratory analysis (NAFDAC may request samples)
Step 6: NAFDAC Food and Drug Registration Committee (FDRC) approval
Step 7: Certificate of Registration issued (if approved)

2.2 DEVICE CLASSIFICATION
Class I: Low risk (e.g. bandages, tongue depressors)
Class II: Low-moderate risk (e.g. surgical gloves, powered wheelchairs)
Class III: Moderate-high risk (e.g. hip replacements, ventilators)
Class IV: High risk (e.g. pacemakers, heart valves)
IVDs: classified under same 4-class system
Similar devices from same manufacturer and premises can be grouped under one application.
Official timeline: 120 working days for new registration.
Device fees: see SECTION 1.6 (Medical Devices 1: USD 750, Medical Devices 2: USD 874 for foreign).
[FIELD] Registration does NOT automatically confer advertising permit. Separate application required.

2.3 WHO CRP FOR MEDICAL DEVICES/IVDs [OFFICIAL -- VBM-R&RA-GDL-014-00, effective 29 April 2025]
CRP route available for WHO-prequalified IVDs and non-IVD medical devices.
Directorate: Vaccines, Biologics and Medical Devices Registration and Regulatory Affairs (VBM-R&RA).
Email for CRP initiation: mdbvmrr@nafdac.gov.ng (unique dossier upload link provided).
Documentation: IMDRF-aligned (IVD MA ToC IMDRF/RPS WG/N13 Ed 2, nIVD MA ToC IMDRF/RPS WG/N9 Ed 3).
Key requirements: notarised declaration, PoA, Certificate of Manufacture and Free Sale (authenticated by Nigerian Embassy), CoA, trademark registration, GMP invitation letter, Declaration of Conformity.
Sameness test: same product name, regulatory version, product code, manufacturing site, QMS, design, components, suppliers, labelling, intended use as WHO-PQ version.
Timeline (CRP route): 60 working days (~90 calendar days) for regulatory decision. Decision communicated within 20 working days (~30 calendar days).
Failure to respond to queries within 90 days: automatic closure.
Variations: must match WHO/PQT accepted variations. Unapproved variations NOT processed under CRP.

2.4 GENERAL DEVICE/IVD REGISTRATION [OFFICIAL -- VBM-R&RA-GDL-001-01, effective 10 April 2025]
Classification (medical devices): Class A (low risk), B (low-moderate), C (moderate-high), D (high risk). Higher class applies if device spans multiple.
Classification (IVDs): Class A (low individual + low public health risk), B (low-moderate individual / low public health), C (high individual / moderate public health), D (high individual + high public health).
Dossier screening clearance: required for Classes B, C, D (moderate and high risk). Email: md.vbmrr@nafdac.gov.ng
Full product dossier (IVD ToC or nIVD ToC per IMDRF): required for Classes C and D only.
QMS certification evidence: required for all classes.
Declaration of Conformity: required for all classes.
TIMELINES: Class A devices/IVDs maximum 120 working days; Classes B, C, D devices/IVDs maximum 240 working days; clock stops when compliance directives issued.
Query response: 90 days or automatic closure.
Registration valid: 5 years. Post-market surveillance plan required.
Class C and D applicants must notify directorate via email (md.vbmrr@nafdac.gov.ng) with application number after NAPAMS submission.

2.5 DEVICE LIFECYCLE GUIDELINES
[OFFICIAL -- VBM-R&RA-GDL-002-00, effective 7 November 2024: Variations to Registered Medical Devices including IVDs] Any change to a registered device must be approved before the modified device is supplied in Nigeria; the guideline defines minor and major change categories, each with a change-type assessment and required documentation.
[OFFICIAL -- VBM-R&RA-GDL-003-01, effective 21 March 2025: Renewal of Certificate of Product Registration for Medical Devices including IVDs] A device renewal may be initiated 6 months before certificate expiry; it requires a current Power of Attorney or contract-manufacturing agreement, a Certificate of Manufacture and Free Sale, the expired NAFDAC certificate, the product market history, a declaration of any variations, and a Post-Market Surveillance report. Renewal timeline: 60 workdays (the clock stops when compliance queries are issued); the new certificate is valid 5 years.
[OFFICIAL -- DR&R-GDL-036-00, effective 1 July 2024: Registration of Software as a Medical Device (SaMD)] SaMD is defined as software intended for one or more medical purposes that performs those purposes without being part of a hardware medical device; it is registered and processed via the NAPAMS portal.

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SECTION 3: COMPLEMENTARY / HERBAL
==============================================================
All regulated by NAFDAC under the same framework. Each requires separate registration.
Herbal medicines: require safety/efficacy data if new/uncharacterised formulation.
Cosmetics: detailed ingredient list and concentrations required. Free sale certificate needed for imports.
Nutraceuticals/supplements: registered as drugs under NAFDAC classification.
Fees: see SECTION 1.6 for the complete NAFDAC Tariff Section G breakdown by product type.

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SECTION 3B: BIOLOGICALS / VACCINES
==============================================================
[OFFICIAL -- VBM-R&RA-GDL-012-00, effective 9 April 2025]
Directorate: Vaccines, Biologics and Medical Devices Registration and Regulatory Affairs (VBM-R&RA).
Email: vb.vbmrr@nafdac.gov.ng
Dossier screening clearance REQUIRED before NAPAMS submission. Email dossier access request first.
Dossier format: searchable PDF (each module in separate folder). QOS and QIS in Word format.
COPP (WHO format) required: authenticated by Nigerian Embassy or Commonwealth/ECOWAS embassy.
GMP certificate: authenticated by Nigerian Embassy.
Biologicals include: human vaccines, veterinary vaccines, biosimilars, biotherapeutic products.
All biological products including NBEs: clinical trial evidence in acceptable population MANDATORY.
Blood-derived products: Plasma Master File + notarised HIV-1/HIV-2/HBsAg/HCV-free certificate + certificate of release from health authority.
Timeline: 240 working days from acceptance to certificate.
Failure to respond to queries within 60 workdays: automatic archival on NAPAMS.
Registration valid: 5 years.
Fees: per NAFDAC tariff Section G -- Vaccines/Biologicals: local NGN 80,000, foreign USD 1,200.

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SECTION 4: CLINICAL TRIALS
==============================================================
NAFDAC approval required before conducting any clinical trial.
NAFDAC-electronic Clinical Trial Application Platform available.
NHREC (National Health Research Ethics Committee) provides ethical oversight.
Bioequivalence studies conducted in Nigeria encouraged (Strategic Plan for BE published).
Summary of Product Characteristics (SMPC) requirements published.
Clinical trial fees: see SECTION 1.6 -- Section C (application USD 1,923 imported IMP, inspection USD 5,494.51, etc.).
[OFFICIAL -- NAFDAC Guidelines for Clinical Trial Process Timelines, DER-GDL-011-02, effective 6 September 2024] Minimum processing timelines in workdays (excluding clock-stops): Clinical Trial Application 60; emergency CTA 10 (re-purposed investigational product) or 15 (new chemical entity); investigational-product import permit issuance 24; quarterly progress and safety reports 20; response to a Compliance Directive 30; SAE report review 21; GCP inspection report 30; protocol amendment 30; final clinical trial report 90. Fatal or life-threatening unexpected serious adverse events must be reported within 7 calendar days (the Principal Investigator's responsibility).
[OFFICIAL -- NAFDAC Guidelines for Clinical Trial Application in Nigeria, DER-GDL-002-03, effective 19 November 2024] No clinical trial may commence without written NAFDAC authorisation, and a valid Clinical Trial Approval is required to import, procure or manufacture a product for a trial. A clinical trial is mandatory for new or relatively new chemical entities and herbal formulations, new indications, new patient populations, new combination products, new dosage regimens, new delivery systems, and devices/IVDs to be tested on humans; the guideline also covers bioavailability/bioequivalence (BA/BE) studies for generic medicines.

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SECTION 5: POST-MARKET / PHARMACOVIGILANCE
==============================================================
Pharmacovigilance: mandatory adverse event reporting via Med Safety App.
Post-market surveillance of all regulated products conducted.
NAFDAC Watchlist and Blacklist of companies publicly available.
Recalls and alerts published on NAFDAC website.
Compliance Directive (CD): clients must comply within 7 working days or face application cancellation.

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SECTION 6: KEY TIMELINES
==============================================================
Drug registration (standard): 240 working days
Drug minor variation: 168 working days
Food registration: 90 working days
Medical device registration: 120 working days
Reliance procedure: registration decision within 60 working days (~90 calendar days)
[FIELD] In practice, drug registration can take 12-18 months with deficiency cycles.
[FIELD] Pre-submission consultation recommended -- reduces post-submission queries by ~25%.

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GUIDELINE INDEX
==============================================================
[OFFICIAL] The current NAFDAC registration guideline suite also includes: Guidelines for Compilation of a Product Dossier for IVDs (IMDRF IVD MA ToC) and for non-IVD devices (IMDRF nIVD MA ToC); Guidelines for Registration of Medical Devices including IVDs (VBM-R&RA-GDL-001-01, effective 10 April 2025; risk classes A-D for devices and A-D for IVDs); the NAFDAC GMP for Medical Devices, IVDs and Related Products Guidelines 2024; Guidelines for Renewal of Certificate of Product Registration for biological products and for medical devices/IVDs; Guidelines on Variations to Registered Medical Devices including IVDs; Guidelines for Registration of Software as a Medical Device (SaMD) in Nigeria; and registration of imported drugs/vaccines/IVDs under the WHO Collaborative Registration Procedure (DR&R-GDL-017-01).
KEY DOCUMENT REFERENCES: NAFDAC Act Cap N1 LFN 2004; DR&R-GDL-005-03 (Imported Drug Products, 20 Mar 2025); DR&R-GDL-014-03 (Locally Made Drugs, 20 Mar 2025); DR&R-GDL-035-01 (Reliance Procedure, 25 Sep 2025); DR&R-GDL-033-01 (Risk Categorization, 7 Dec 2024); DR&R-GDL-025-04 (Drug Renewal, 20 Dec 2024); DR&R-GDL-019-02 (Variations, 29 Aug 2024); DER-GDL-023-00 (Contract Manufacturing); DER-GDL-009-01 (Bioequivalence 2025); DER-GDL-022-01 (API Importation, 25 Mar 2026); DER-GDL-011-02 (Clinical Trial Timelines); DER-GDL-002-03 (Clinical Trial Application); VBM-R&RA-GDL-001-01 / 002-00 / 003-01 / 012-00 / 014-00 (devices, IVDs, biologicals); DR&R-GDL-036-00 (SaMD); NAFDAC Tariff 2020.

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SHAAMI SOUTH AFRICA REGULATORY KNOWLEDGE BASE -- SAHPRA
Regulator: South African Health Products Regulatory Authority (SAHPRA)
Legal basis: Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended
Address: Civitas Building, Cnr Thabo Sehume and Struben Streets, Pretoria
Website: www.sahpra.org.za
SAHPRA replaced the Medicines Control Council (MCC) in 2018
WHO Maturity Level 3 (achieved)
PIC/S member (GMP aligned with PIC/S Annex 16 as of Nov 2025)
Portal: eCTD submission portal
Sources: SAHPRA Guidelines, Government Gazette fees (Feb 2025), secondary sources
Last updated: April 2026
==============================================================

REGULATOR AND PORTALS
- eCTD portal for all medicine submissions (ZA-specific Module 1)
- Medical Device Submissions Portal (MDSP) for device applications
- SAHPRA publishes ReguLetter newsletters, rapid alerts, OTC directory
- Registration valid: 5 years (medicines), renewable
- ISO 9001 certified authority

LOCAL REPRESENTATIVE
(SAHPRA terminology: Holder of Certificate of Registration (HCR) for medicines; Local Responsible Person (LRP) for medical devices)
Foreign manufacturers MUST appoint a South African Holder of Certificate of Registration (HCR) for medicines, or a Local Responsible Person (LRP) for medical devices. HCR/LRP must be a South African legal entity. They are the legal representative and primary SAHPRA contact.

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SECTION 1: MEDICINES (HUMAN)
==============================================================
Dossier format: eCTD with ZA-specific Module 1
General Information Guideline: SAHPGL-HPA-07 (Sep 2025)
Stability: ICH-aligned (Zone IVb for tropical conditions)
Language: English (UK)

1.1 REGISTRATION PATHWAYS
Full Review -- NCE, biologicals, generics with clinical data. Full CTD assessment.
RELIANCE-BASED EVALUATION [OFFICIAL -- SAHPGL-BAU-01 v6, December 2025]
Three reliance pathways (replaced prior Abbreviated Medicines Review Process / AMRP):
(a) Abridged review: SAHPRA makes decisions based on UNREDACTED full assessment reports from RRAs. Full CTD still required.
(b) Verified review: further streamlined -- primarily verifying (not evaluating) information against what RRA already approved.
(c) Recognition: MA based on directly recognising outcome of an RRA review (requires recognition agreement -- none concluded yet as of 2025).
NOTE: CMC and clinical may follow DIFFERENT pathways for same application (e.g. CMC abridged but clinical full review).

SAHPRA RECOGNISED REGULATORY AUTHORITIES (RRAs):
- US FDA
- EMA (Centralised and Decentralised Procedures only)
- MHLW/PMDA (Japan)
- Health Canada
- Swissmedic
- TGA (Australia)
- MHRA (UK)
Additional collaborative procedures (not strictly RRAs):
- WHO Prequalification (WHO PQ)
- ZAZIBONA work-sharing procedure

ZAZIBONA RELIANCE PATHWAY:
ZAZIBONA is a SADC regional collaborative initiative for work-sharing (not strictly an RRA).
Parallel submissions to SAHPRA and ZAZIBONA NOT permitted. Must wait for ZAZIBONA outcome first.
On receipt of positive ZAZIBONA recommendation + valid application: SAHPRA targets 90 working days for decision after screening.
SAHPRA Communication to Stakeholders (Feb 2026) formalised ZAZIBONA reliance process.
Collaborative procedure must be stated in cover letter (Module 1.0.1) of application.

KEY RELIANCE FINDINGS (published study, BCP 2019-2022):
- Only 20-30% of applications qualified for abridged review (unredacted reports obtained).
- Most unredacted reports came from EMA (31/43 CMC, 36/50 clinical), then TGA, rarely from Swissmedic/MHRA/FDA/Health Canada.
- Public assessment reports NOT accepted -- only unredacted full reports.
- CMC reliance successfully implemented. Clinical reliance less effective (40-84% labelling non-alignment).
- SAHPRA signed MOUs with US FDA, EMA, MHRA, TGA, Swissmedic to increase report access.
- EMA SmPC is default PI/PIL reference for reliance. SA-specific labelling differences common (especially Section 4.6 fertility/pregnancy/lactation: 84% non-alignment).
[FIELD] Abridged review reduces NCE quality review cost by ~77% vs full review (published 2025).
[FIELD] Only 20-30% of applications qualify for abridged -- main barrier is availability of unredacted RRA reports.
[FIELD] Median approval from 26 months reduced to less than 18 months with reliance. Full review can exceed 18 months, abridged/verified may conclude in 9-12 months.
Priority Review -- For products with approvals from 2+ recognised reference authorities. Faster timeline.
Risk-Based Assessment (RBA) -- Implemented to clear backlog. Pilot completed 2021-2022.

1.2 RECOGNISED REFERENCE AUTHORITIES
US FDA, EMA, Health Canada, TGA (Australia), PMDA (Japan), Swissmedic, UK MHRA
For devices: CE Certificate under EU MDR/IVDR from Notified Body also accepted

1.3 FEES -- MEDICINES [OFFICIAL -- Government Gazette, 12 February 2025]
All fees in South African Rand (ZAR).
New medicine registration application: R1,900 (admin/screening)
Generic application (with BE, standard): approximately R86,000-R132,400
NCE application: higher tier (exact amounts per gazette category)
Priority generic with clinical data: approximately R132,400 (53% premium over standard)
Biological application: approximately R184,400-R282,300
Clinical trial application (safety/efficacy): R33,700
Annual retention fee: payable by last working day of June each year
Renewal of certificate of registration: new fees gazetted Feb 2025 (cost-to-serve basis)
[OFFICIAL -- Government Gazette No. 52106, Notice 5856, 12 February 2025. First increase since Dec 2020 (avg 4.1%)]
All fees in ZAR. Screening fees removed. 1st response review INCLUDED in application fee. 2nd+ rounds charged separately.
Reliance does NOT reduce fees (only timelines) -- same processes, verification of sameness is resource-intensive.
Medical device registration fees WITHDRAWN from this gazette (separate process pending after pilot).

CATEGORY A: NEW MEDICINE REGISTRATIONS:
NCE / new biotherapeutic (1st strength/dosage form, incl 2 APIs): R217,200
NCE additional strengths/dosage forms: R85,400
Biological products (vaccines excl biotherapeutics): R184,400
Biosimilar: R180,300
Biosimilar additional strengths: R57,300
Generic (pharma + analytical, no BE, 2 APIs): R87,600
Generic (pharma + analytical + BE, 2 APIs + 1 BE study): R120,000
Generic additional strengths/dosage forms: R28,100
Generic with clinical data: R87,600

PRIORITY REVIEW (premium over standard):
Priority review application (admin): R11,500
Priority generic (pharma + analytical + BE): R192,000 (60% above standard)
Priority generic (pharma + analytical, no BE): R132,400 (53% above standard)
Priority generic with clinical data: R188,000
Priority NCE/biotherapeutic: R300,000 (38% above standard)
Priority biological (vaccines): R282,300 (53% above standard)

ADDITIONAL APIs AND BE STUDIES:
Each additional API source beyond 2: R18,600
Each additional BE study beyond 1: R26,200

POST-REGISTRATION VARIATIONS:
Certificate variation (Section 15(3)): R2,100
Rescheduling/reclassification: R16,600
PI/PIL amendment (safety data, Type II): R16,200
PI/PIL amendment (safety + efficacy data, Type II): R32,800
PI/PIL amendment (no clinical data, Type IA): R3,300
Priority Quality Type II major amendment: R23,000
Priority Safety Type II: R29,500
Priority Safety + Efficacy Type II: R44,900

2ND RESPONSE REVIEW FEES:
Major queries: R45,000
Moderate queries: R22,500
Minor queries: R9,000
Clinical 2nd response with data: R24,700
Type II variation response per variation: R6,800

PRE-REGISTRATION CONSULTATION (biologicals):
Type A (pre-non-clinical): R43,200
Type B (post-non-clinical): R32,400
Type C (clinical development): R21,600

BORDERLINE PRODUCT STATUS REVIEW: R15,000

MEDICAL DEVICE ESTABLISHMENT LICENCE FEES [OFFICIAL -- SAHPGL-MD-07 v4, 21 May 2025]:
New licence application: Manufacturer R26,200 | Distributor R15,600 | Wholesaler R15,600.
Renewal: Manufacturer R22,900 | Distributor R13,100 | Wholesaler R13,100.
Licence amendment: R5,500. Licence issuing / collection fee (payable on approval, before the licence is issued): R3,500.
Annual retention fee: R4,400 (due by the last working day of June; first due the year after approval; non-payment can cause licence cancellation).
Notification (a change not affecting licence details): R0 -- no fee. Certificate of Free Sale: R1,460.
Application fee is payable BEFORE submission; the collection fee is payable when the notice of approval is sent.
Device PRODUCT registration fees: still NOT PUBLISHED (pending the feasibility study) -- although fee CATEGORIES MD-EVA/EVB/EVC/EVD now exist in the Fee Categorisation.

CLINICAL TRIALS: R33,700 (per gazette for safety/efficacy application)

CERTIFICATE OF FREE SALE (devices): per Gazette 52106 (amount not separately specified)

Payment: EFT only. No cheques. No invoices provided by SAHPRA.
SMME/local manufacturing fee reduction: under consideration (not yet implemented).
[FIELD] SAHPRA fees are the highest among African regulators. Budget R87,600-R300,000+ for medicine registration.
[FIELD] Reliance (abridged) reduces review COST to SAHPRA by ~77% for NCE quality reviews (published 2025) but applicant fee is the same.

GxP INSPECTION FEES [OFFICIAL -- SAHPGL-INSP-06 v2, 18 September 2022]
SAHPRA charges a compensatory calculated fee for GMP / GCP / GWP / Pharmacovigilance / Cannabis-cultivation inspections, billed AFTER the inspection based on actual hours spent.
Rate: R1,600 per hour per inspector -- applies to LOCAL and INTERNATIONAL inspections, on-site and remote/virtual.
Travel time within South Africa is charged per hour per inspector (0.5-2 hours one way depending on province); accommodation/subsistence within SA is NOT charged to the applicant.
International inspections: applicant pays all travel + accommodation costs; SAHPRA pays visas + travel insurance. Travel time charged one-way per inspector: neighbouring countries 4h, rest of Africa 8h, rest of world 16h.
Maximum on-site inspection hours by type (x number of inspectors): GMP biologicals upstream/downstream 40h x2; GMP sterile 40h x2; GMP non-sterile 32h x2; GMP non-sterile QC laboratory 32h; HCR 16h x1; GCP sponsor-driven 32h x2; GCP investigator-driven 24h; GWP 16h x1; pharmacovigilance 32h. Remote/hybrid inspections billed at higher hours (GMP sterile 50h, GMP non-sterile 40h, etc.).
WORKED EXAMPLE: a GMP-sterile international inspection ~80 inspector-hours = approx R128,000 inspection fee, PLUS travel-time hours (e.g. 2 inspectors x 16h x R1,600 = R51,200) PLUS applicant-funded flights and accommodation.
For international sites SAHPRA may instead perform a DESKTOP REVIEW of valid GMP certificates issued by a PIC/S-aligned regulatory authority (no physical inspection) -- but reserves the right to inspect.
GxP inspection fees due within 30 calendar days of invoice. This guideline does NOT cover medical device establishment inspections.

SECTION 22A PERMIT FEES (controlled substances -- Schedule 5/6/7/8 narcotics and psychotropics) [OFFICIAL -- SAHPGL-INSP-RC-06 v1, June 2022]
Export Permit R925 | Export Authorisation R925 | Import Permit R950 | Import Authorisation R950 | Manufacturing and Possession permits issued under Section 22A(9)/22A(11).
Import/export of samples of registered medicines (registration or analytical purposes): R350. Release of health products held at a port of entry without SAHPRA approval documents: R350 evaluation fee.
Turnaround: 20 working days for a Section 22A permit decision from receipt of a complete application; acknowledgement within 48 working hours. Reference numbers (LEU/RCD/RCS) must be obtained before submission via sec22a_permits@sahpra.org.za.

PAYMENT PROCESS AND BANKING [OFFICIAL -- SAHPGL-FIN-01 v9, 12 February 2025]
Payment: EFT / direct deposit only, no cheques. ONE payment per service -- bulk payments for multiple services are NOT accepted. SAHPRA does not issue pro-forma invoices upfront for product applications.
Bank: ABSA, account name "South African Health Products Regulatory Authority", account no. 40-5939-2080, branch code 632005, Swift ABSAZAJJ.
Payment reference must follow the SAHPRA Fee Categorisation 14-character codes. Proof of payment + completed Applicants Cover Page emailed to pop@sahpra.org.za, copying the relevant unit.
Pay only when the application/dossier is ready to submit. If payment is received without an application: 14 working days to submit or the amount is forfeited (extension must be requested before expiry; response in 3 working days). If a payment is unidentifiable after 12 months, SAHPRA's refund liability is forfeited. Payment queries: finance@sahpra.org.za / 012 501 0470.
NOTE: the SAHPRA Fee Categorisation (Gazette 2025, Annexure A of FIN-01 v9) DOES list medical device registration evaluation categories MD-EVA / MD-EVB / MD-EVC / MD-EVD (Class A/B/C/D) and IVD manufacturer/distributor/wholesaler licensing categories -- even though the device product-registration fee AMOUNTS remain withdrawn pending the feasibility study.

1.4 GMP REQUIREMENTS
SAHPRA Guidelines to Good Manufacturing Practice v9 (Nov 2025) -- aligned with PIC/S Annex 16.
API manufacture: SAHPRA wholly adopts ICH Q7 [OFFICIAL -- SAHPGL-INSP-GMP-02 v1, effective 27 October 2025], read together with SAHPRA's Guide to GMP for Medicines (SAHPGL-INSP-02), which prevails in any conflict.
Manufacturing/wholesale licences required for all sites.
ISO 13485 certification mandatory for medical device manufacturers (from renewal stage).
GMP inspection costs: cost recovery basis -- see GxP Inspection Fees above (R1,600/hour/inspector).

1.5 RENEWAL OF CERTIFICATE OF REGISTRATION [OFFICIAL -- SAHPGL-HPA-04 v6, 17 February 2025]
Medicine registration is valid 5 years. A renewal application must be submitted at least 6 MONTHS before expiry.
Certificates issued from 1 October 2022 carry an expiry date; older products renew via an applicant-specific renewal roadmap (SAHPRA assigns a year/quarter per product based on the applicant's number of active registrations).
Full renewal review timeframe: 120 working days (6 months) from submission to issuance of the revised certificate.
Screening: 1 round of queries, 10 working days to respond. Evaluation: maximum 2 rounds of queries, 30 working days to respond each round. Handled by a dedicated Renewals workstream.
No variations are accepted within a renewal application; no pending Transfer of Applicant (ToA) is allowed at renewal.
If neither a renewal nor a formal cancellation is submitted, the medicines register status is changed to "Cancelled" (loss of registration).
Renewal dossier requires: full eCTD baseline (if dossier not yet converted to eCTD); Product Quality Review (PQR -- minimum 10 consecutive batches over 12 months, or 25 consecutive batches over 36 months); 5-year risk-benefit assessment report (executive summary of PBRERs/PSURs); CPP (WHO Certification Scheme) from the country of manufacture; GMP certificates for API and FPP manufacturing sites; QIS; current SAPC registration of the responsible pharmacy/pharmacist.
Renewal application fee: non-refundable, per the Fees gazette.

1.6 MULTIPLE / DUPLICATE / CLONE / REPLICA APPLICATIONS [OFFICIAL -- SAHPGL-HPA-08 v3, effective 1 January 2024]
Duplicate (multiple) application: 2+ applications submitted SIMULTANEOUSLY by the same applicant, identical in every aspect except proprietary name. Must be submitted WITH the master dossier -- if submitted later it is treated as a standalone application.
Clone: a copy of the innovator's OWN product under a different proprietary name, submitted by the innovator HCR after registration.
Replica: a copy of an already-registered GENERIC product, submitted by the same or a different applicant (a different-applicant replica requires a Letter of Permission to use the originator's data).
A single "master" dossier is evaluated; a separate registration certificate is issued for each approved proprietary name. Pre/post-registration changes are made only to the master and applied across all linked dossiers.
FEES: master = fee as published; each duplicate = same fee as the master; clone/replica = same fee as the registered product's current fee. A Declaration of Sameness signed before a Commissioner of Oaths is required for clones and replicas.

1.7 IMPORT / EXPORT OF MEDICINES AND PORTS OF ENTRY [OFFICIAL -- SAHPGL-INSP-RC-02 v2 and SAHPGL-INSP-RC-11 v2, June 2022]
A licence to import or export medicines / scheduled substances is required under Section 22C(1)(b) of the Medicines Act, valid 5 years; the licence holder must appoint a responsible pharmacist. Section 22C(6): no person may import or export a medicine without this licence.
Imported medicines must be accompanied by: the Section 22C(1)(b) licence; and the Section 15 certificate of registration (or a Section 21 authorisation if the product is unregistered). An MBR 20 document (form GW 12/11) is completed per consignment and lodged with Customs at the port of entry.
Schedule 5/6/7/8 substances additionally require an import/export PERMIT (forms GW 12/10 import, GW 12/44 export), issued via the Director-General of Health, valid 6 months. A permit may be refused if a product of acceptable quality is already available in South Africa, or if the import quota is exceeded.
Designated health-product ports of entry (7): OR Tambo International Airport, King Shaka International Airport, Durban Harbour, Cape Town International Airport, Cape Town Harbour, Port Elizabeth Airport, Port Elizabeth Harbour.
Release of imported health products held at a port of entry: SAHPRA decision within 4 working days of a complete application (including fee). Goods in transit through RSA must be held in a Section 22C-licensed bonded warehouse under Good Distribution Practice.
Personal importation: a traveller may carry up to 6 months' supply of a Schedule 3/4/5 substance, or 30 days of a Schedule 6 substance, with a valid prescription.

1.8 SITE MASTER FILE [OFFICIAL -- SAHPGL-INSP-04 v5, 18 September 2022]
A Site Master File (SMF) describing the quality assurance, production and/or quality control of each pharmaceutical site is prepared by the manufacturer / wholesaler and used by SAHPRA to plan GMP / GWP inspections. The SMF must carry an edition number and effective date; an updated SMF must be submitted to SAHPRA every 5 years and whenever there is a major construction upgrade or a change of key activities or key personnel.

1.9 MANUFACTURER / IMPORTER / EXPORTER / WHOLESALER LICENSING (SECTION 22C)
Any entity that manufactures, imports, exports, wholesales or distributes medicines or scheduled substances in South Africa must hold a Section 22C(1)(b) licence from SAHPRA -- so a foreign manufacturer's local importer/HCR needs the relevant licence. Licences are valid 5 years; renewal must be lodged at least 180 days before expiry; changes are reported to the SAHPRA CEO within 30 days. A new licence requires a Site Master File, a Responsible Pharmacist named on the licence, an NDOH premises licence, SAPC pharmacy recordings and a pre-licensing GMP/GWP inspection. Up to 2 query rounds; application fees are non-refundable. Processing clocks count only active SAHPRA review time (time with the company is excluded).
[OFFICIAL -- SAHPGL-LIC-01 v4, March 2026: Manufacture/Import/Export Licence] New application target 150 business days; renewal 30 business days; amendment 30 business days (longer if an inspection is triggered); receipt acknowledged within 2 business days; regulatory decision within 30 business days of an inspection resolution letter.
[OFFICIAL -- SAHPGL-LIC-02 v3, March 2026: Wholesaler Licence] New wholesale licence target 160 business days; renewal 30 business days (submit 180 days before expiry); amendment 30 business days. A wholesaler may buy only from the original manufacturer or primary importer (Section 22H); transport companies are not separately licensed; records kept 5 years.
[OFFICIAL -- SAHPGL-LIC-03 v2, March 2026: Licence Amendment] Amendments are administrative (responsible pharmacist, CEO/MD, non-storage address) or technical (company name, manufacturer address, new activity, new equipment/lines, structural change). Technical amendments generally require Inspectorate approval before implementation; finalised within 30 business days where no inspection is needed.
[OFFICIAL -- SAHPGL-LIC-05 v2, March 2026: Import/Distribute Scheduled Substances] Covers wholesalers importing scheduled substances/APIs for manufacture or compounding of registered medicines. New application 160 business days; renewal 30 business days; a site inspection is required. A consignment lacking a valid import licence is held under Extended Health Detention (EHD) in a SAHPRA-registered bonded warehouse until documents are produced. Schedule 5/6 substances additionally need a Section 22A(9)/(11) permit.
A licensed wholesaler/distributor must operate in compliance with South African Good Wholesaling Practice [OFFICIAL -- SAHPGL-INSP-03 v5, 18 September 2022] -- the GWP code covering quality management, customer and vendor verification, premises and warehousing, transport, recall, returns, disposal and counterfeit handling; GWP compliance is verified at inspection.

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SECTION 2: MEDICAL DEVICES & IVDs
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Regulation: Regulations relating to Medical Devices and IVDs (Government Gazette 40480, Dec 2016)
Classification: Risk-based (Class A-D), IMDRF-aligned
SAHPRA Medical Device Establishment Licence required for manufacturers, wholesalers, distributors.
Non-sterile, non-measuring Class A devices are EXEMPT from licensing.
ISO 13485:2016 certification MANDATORY for all device classes.
ISO 13485 ENFORCEMENT TIMELINE: Phase 1 (until Apr 2025) awareness. Enforcement now ACTIVE starting with licence renewals.
eCTD now MANDATORY for most human medicine applications (excluding complementary and veterinary).
Labels: must appear in English + at least one other official SA language (multilingual requirement, per SAHPGL-PEM-05 v1).
AI/ML-enabled medical devices: SAHPRA actively developing regulatory approach (2025).
Device Registration Feasibility Study update (Oct 2025): 15 applicants, 22 products received (of 32 targeted). Preliminary report expected FY2025/26. NO Call-Up Notices issued as of Nov 2025.
Draft Medical Device Registration guidelines published. Full registration framework under phased implementation.
Voluntary feasibility study for device registration initiated May 2024.
[CRITICAL] As of 2026, SAHPRA has NOT yet called up medical devices for full product registration. Status:
- Establishment licensing: ACTIVE and MANDATORY for Class B/C/D (Class A non-sterile/non-measuring exempt)
- Product registration: NOT YET ENFORCED. Voluntary Feasibility Study started May 2024 for HIV and TB test kits only (32 products). Phase-based rollout planned prioritising high-risk devices.
- No official device product registration fees published yet (only establishment licensing fees exist).
- When product registration becomes mandatory: Certificate valid 5 years, renewal 6 months before expiry.
- Priority review pathway planned: 2+ recognised reference authority approvals = fastest track.
- Local Responsible Person (LRP) required for all foreign manufacturers -- acts as legal representative, manages submissions, vigilance reporting, variation applications.
[OFFICIAL -- SAHPGL-MD-21 v1, 26 March 2026: Guideline for Medical Device Certificate of Free Sale]
CFS confirms devices are legally sold in SA, freely without restriction, and listed by SAHPRA.
CFS may ONLY be issued for devices listed on approved Medical Device Establishment Licence Form GLF-MD-06A.
NOTE: devices have NOT been assessed for safety/performance by SAHPRA -- listed as part of establishment licensing only.

ELIGIBILITY:
- Must hold valid SAHPRA manufacturer's licence (Section 22C)
- Product must be listed in licence application form GLF-MD-06A
- Product must be legally sold in SA
- Applicant must be licence holder or Authorised Representative
- Eligible classes: Class A (sterile/measuring only), B, C, D
- Class A non-sterile/non-measuring: exempt from Section 22C per Government Notice No. 5855 (Gazette 52105, 12 Feb 2025) -- separate declaration process
- Product must NOT be subject to open recall or Field Safety Corrective Action (FSCA)

REQUIRED DOCUMENTATION:
- Cover letter to CEO of SAHPRA, subject: "RE: APPLICATION FOR A CERTIFICATE OF FREE SALE"
  Must state: rationale, product(s), destination country/ies, intended use (e.g. regulatory submission, market access)
- Completed form GLF-MD-21A (signed by Authorised Representative, PDF)
- Product listings with GMDN codes and descriptions, SA risk classifications
- Class C/D: evidence of pre-market approval from at least one of 6 recognised jurisdictions (TGA, ANVISA, Health Canada, EU, Japan, US FDA) or WHO PQ for IVDs. May be waived for locally manufactured products.
- ISO 13485 certification of original manufacturer (Class C/D)
- Declaration of Essential Principles compliance (Class C/D)
- Valid SAHPRA establishment licence copy (unless exempt Class A)
- Proof of payment

SUBMIT TO: mdreg@sahpra.org.za (electronic PDF submission)
PROCESSING: 15 working days if complete.
DEFICIENCIES: respond within 2 working days. Max 2 review rounds.
VALIDITY: 12 months from date of issue.

CFS CONTAINS: manufacturer name, site address, licence number (or CFSF reference for exempt Class A), GMDN codes/descriptors, device names, SA risk class, recipient countries, issue/expiry dates, Authorised Representative details, official seal (physical copy only).

FEES: per Government Gazette No. 52106 (Government Notice No. 5856). Updated periodically.
False statements: offence punishable by fine or up to 10 years imprisonment.

RECOMMENDATION: contact destination country consulate/embassy BEFORE applying to confirm what information they require.
- Medical Device Submissions Portal (MDSP) being developed for electronic registration submissions.
Device establishment licence application forms: v5 (effective Oct 2025)
[OFFICIAL -- SAHPGL-MD-06 v3, Mar 2023: Device Establishment Licensing]
Class C and D imports MUST have pre-market approval from at least one of:
  TGA (Australia) | ANVISA (Brazil) | Health Canada | EU CE | Japan MAH | US FDA 510(k)/PMA | WHO PQ (IVDs only)
Certificate of Free Sale: required for Class B, C, D from country of manufacture/final assembly.
Authorised Representative: must be SA-resident natural person with written mandate from manufacturer.
Separate licence types: manufacturer, distributor, wholesaler, importer, exporter.
Abridged pathway: available for devices approved in recognised reference markets (FDA, TGA, Health Canada, PMDA, EU MDR/IVDR CE mark)
Priority review: 2+ recognised reference authority approvals
Annual retention fees applicable to licence holders: R4,400, due by June each year
Certificate of Free Sale: valid max 1 year (fee R1,460)

DEVICE LICENCE TYPES AND PROCESS [OFFICIAL -- SAHPGL-MD-07 v4, 21 May 2025]
Three establishment licence types: Manufacturer (form GLF-MD-06A) -- covers manufacture + import + distribution + export; Distributor (GLF-MD-06C) -- covers import + export + distribution; Wholesaler (GLF-MD-06B) -- local trade only, cannot import or export. Manufacturing activities include packaging, labelling, servicing and refurbishment.
Processing time: 6-8 weeks for both new licence and renewal. Submit to mdadmin@sahpra.org.za.
Renewal must be submitted at least 90 days before licence expiry; renewals lodged less than 6 weeks before expiry are NOT accepted (a new application is required); an expired licence cannot be renewed. Renewal allows a maximum of 2 review rounds, with 2 working days to respond to deficiencies.
Amendment (fee R5,500) = a change affecting licence details (entity name, address, Authorised Representative, licence holder, adding a new device class). Notification (R0) = a change NOT affecting licence details (GMDN codes, manufacturer/supplier details, adding same-class already-approved products). Both must be submitted and approved.
Manufacturers and Distributors submit a Quality Manual; Wholesalers submit a Site Master File. GMDN code = a 5-digit numeric code obtained from the GMDN Agency. Section 36 of Act 101 of 1965 allows applications for exemption from provisions of the Act.

DEVICE CLINICAL EVALUATION AND INVESTIGATION [OFFICIAL -- SAHPGL-MD-16 v1 and SAHPGL-MD-17 v1, both 8 September 2025, effective 25 August 2025]
Clinical evaluation (SAHPGL-MD-16): every medical device requires clinical evidence appropriate to its class to demonstrate conformity with the Essential Principles of Safety and Performance before market placement. Three stages -- identification of standards/clinical data, appraisal, analysis -- documented in a Clinical Evaluation Report (CER). Aligned with ISO 14155:2020, ISO 14971:2019 and IMDRF guidance. IVD clinical evidence to be addressed by a separate guideline.
Clinical investigation (SAHPGL-MD-17): a Clinical Investigation of a Medical Device (CIMD) must be APPROVED BY SAHPRA before it commences; an investigational device may only be imported with SAHPRA approval. Applications are submitted via the SAHPRA Regulatory Information Management System (RIMS) with the gazetted fee. The investigation must be registered on the South African National Clinical Trials Register (SANCTR) and approved by a research ethics committee. Reporting: serious adverse device effects within 10 working days; progress reports every 6 months; ethics-committee withdrawal or trial suspension/termination notified within 5 working days. SAHPRA may inspect an ongoing investigation without prior notice.

DEVICE POST-MARKET SURVEILLANCE AND VIGILANCE [OFFICIAL -- SAHPGL-MD-18 v1, 8 September 2025; SAHPGL-MD-11 v1, 13 December 2024]
Post-Market Surveillance: manufacturers, importers, distributors and HCRs must operate a PMS plan. Post-Market Clinical Follow-Up (PMCF) studies are indicated where residual risks or long-term-performance uncertainty exist -- novel devices, high product-related risk, implants, high-risk anatomical locations, high-risk populations (paediatric/elderly), or where approval was equivalence-based.
Adverse event reporting: use form GLF-MD-11A (one device per form; report types initial / follow-up / final) submitted to mdvigilance@sahpra.org.za, Tel 012 501 0476 (Loftus Park, Building A, Kirkness Road, Arcadia, Pretoria).

MEDICAL DEVICES RELIANCE GUIDELINE [OFFICIAL -- SAHPGL-MD-22 v1, effective 25 February 2026]
Defines reliance-based review for medical devices and IVDs across establishment licensing, product registration, clinical trial approval, ISO 13485 audits and post-market surveillance. Does NOT replace the medicines reliance guideline SAHPGL-BAU-01, and does NOT apply to Class A non-measuring/non-sterile devices. A device with no prior approval from a recognised authority follows the FULL evaluation route.
Four reliance pathways: (a) Abridged review -- streamlined review relying on a comprehensive assessment by a trusted authority (RRA, WHO Listed Authority, WHO CRP/PQ/EUL, AMA continental procedure); (b) Recognition -- accepting another authority decision, e.g. verifying OEM audit outcomes via MDSAP (SAHPRA is an MDSAP affiliate member) or recognised Conformity Assessment Bodies (CABs); (c) Work-sharing / Joint assessment -- primary plus secondary review with a joint assessment session, applied to AMA/AMRH continental evaluations; (d) Verification -- confirming sameness of the device against what a reference authority approved.
Establishment licensing uses the verification pathway and relies on ISO 13485 audits by locally recognised CABs. Product registration of Class B/C/D uses dossier guidance SAHPGL-MD-09 (IVD technical dossier) and SAHPGL-MD-10 (non-IVD technical dossier). PMS verification considers RRA/WLA safety reports, the FDA MAUDE database and WHO global surveillance.

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SECTION 3: COMPLEMENTARY / HERBAL
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Complementary medicines (herbal, homeopathic, Ayurvedic, traditional) are NOT currently being registered by SAHPRA.
Borderline committee determines classification (medicine vs device vs complementary).
Complementary medicines: dedicated portal active at sahpracm.org.za/catd/. Separate registration pathway from orthodox medicines.

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SECTION 3B: BIOLOGICALS / VACCINES
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BIOLOGICALS / VACCINE LOT RELEASE [OFFICIAL -- SAHPGL-PEM-BIO-01 v4]
Every lot of a human vaccine must undergo independent lot release before sale, performed per WHO guidelines by the South African National Control Laboratory for Biological Products (SANCLBP). The HCR submits a lot summary protocol; release is processed via the lot-release portal (medapps.sahpra.org.za:6006/LR). General QSE guidance for biologicals: SAHPGL-PEM-BIO-06 v3.

PLASMA MASTER FILE FOR PLASMA-DERIVED MEDICINAL PRODUCTS [OFFICIAL -- SAHPGL-PEM-BIO-09 v1, finalised 23 February 2026]
Registration or variation of a plasma-derived medicinal product (PDMP -- e.g. clotting factors, immunoglobulins, albumin) requires a Plasma Master File (PMF) describing the quality and safety of the plasma starting material. The PMF is a STAND-ALONE document, separate from the marketing-authorisation dossier; each PDMP dossier must identify and cross-reference its PMF(s). It applies to Category A medicines manufactured from plasma or plasma intermediates; a PMF holding valid EU PMF certification is exempt.
The PMF covers: plasma source and collection sites; epidemiological data on blood-transmissible infections; donation characteristics and donor selection/exclusion criteria; testing of donations and plasma pools for infectious agents; plasma quality and safety; storage and transport conditions; and the plasma specification with pool batch-analysis data.
Key requirements: plasma must comply with Ph. Eur. Monograph 0853 (Human Plasma for Fractionation) or the equivalent WHO standard; every blood establishment / plasma collection centre must be GMP-inspected and approved annually by a competent authority; NAT testing for HBV DNA, HCV RNA and HIV-1/HIV-2 RNA; a 45-day inventory hold from donation to the first manufacturing step; traceability records retained 30 years. The PMF must be UPDATED AND RE-SUBMITTED FOR APPROVAL ANNUALLY. EU or WHO directives are both acceptable.

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SECTION 4: CLINICAL TRIALS
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[OFFICIAL -- SA GCP Guidelines + Clinical Trials Guidelines]
Application via CTF1 form, protocol, IB, informed consent, ethics approval.
All investigators: must be SA-registered with relevant statutory health council, GCP-trained (certificate required), and RESIDENT in South Africa.
Comprehensive no-fault insurance for serious injury/harm/death mandatory (sponsor responsibility).
Professional indemnity insurance for all investigators required.
Ethics: Human Research Ethics Committee (HREC) approval required. SAHPRA and HREC reviews may run in parallel but SAHPRA approval only finalised after HREC approval obtained.
Section 21: pathway for unregistered medicines access (individual patient compassionate use). Category A medicines via Engagement Portal.

DRUG PRICING:
Single Exit Price (SEP) system under Medicines Act. Ministry of Health gazettes annual SEP adjustments.
All medicines must have SEP assigned before marketing. Logistics fee and dispensing fee regulated separately.
International benchmarking used for originator pricing. Generic pricing based on percentage of originator.

SCHEDULING:
Medicines scheduled S0 (unscheduled) through S8 (controlled). Consolidated Schedules published (latest Aug 2025).
Names and Scheduling Committee reviews substance classifications. Scheduling determines OTC vs prescription status.
Complementary medicines: separate scheduling framework.
[OFFICIAL -- SAHPGL-CEM-NS-01 v2: Rescheduling of a Substance or Medicine] A rescheduling application (form GLF-CEM-NS-01A) is handled as a Type II variation via the SAHPRA Engagement Portal; processing timeline 220 working days; query responses due within 20 working days. Moving a product to a lower schedule requires a unique proprietary name and a separate de-linked registration dossier. SAHPRA recommendations are gazetted by the Minister of Health.
Investigators must be qualified, registered with statutory councils, and resident in South Africa.
All sites must comply with GCP.
Trials registered on South African National Clinical Trials Register.
Ethics approval from accredited NHREC-registered ethics committee required.
Clinical trial application fee: R33,700 (Gazette 2025)

CLINICAL TRIAL GUIDELINE SUITE -- 2026 UPDATES (SAHPGL-CEM-CT SERIES)
[OFFICIAL -- SAHPGL-CEM-CT-05 v4, March 2026: Liability Insurance for Clinical Trials] Comprehensive no-fault insurance for serious injury/harm/death is MANDATORY for interventional trials (phases 1-3). The sponsor/applicant carries strict liability and must indemnify investigators and trial sites (except for proven negligence/malpractice). A trial-specific insurance certificate must accompany the SAHPRA application stating: insurer name/local address + contact, protocol number, cover dates (inclusive of the approval date, trial duration and a reasonable period for late-onset injuries), per-occurrence and total liability limits, and a declaration of compliance with SA GCP and ABPI guidelines. Deductibles/co-payments payable by the participant are NOT permitted. Insurance must be underwritten by a company compliant with the SA Insurance Act 18 of 2017; a local insurance vendor must be named if cover is foreign. Investigator personal malpractice/professional indemnity cover is separate and additionally required.
[OFFICIAL -- SAHPGL-CEM-CT-12 v1, effective 1 June 2026: Pre-Clinical Testing and Phase I / First-in-Human (FIH) Studies] New guideline, adopts ICH M3(R2). Pre-clinical data (safety pharmacology, primary pharmacodynamics, PK/toxicokinetics, acute and repeated-dose toxicity) reported in the CTF-1. Starting dose justified via the NOAEL (empirical) or minimal-anticipated-biological-effect (mechanistic) approach. Sentinel dosing of 2 participants (1 active, 1 placebo) is the minimum for the first SAD and MAD cohorts. Phase 1 cohorts are typically ~20 participants, under 100 total. FIH trials require 4-weekly progress reports on a SAHPRA template plus SAE reporting within 24 hours; a pre-study SAHPRA GCP Inspectorate inspection may be required. Decisions by FDA/EMA/MHRA and ZAZIBONA are considered where available.
[OFFICIAL -- SAHPRA Guideline for Clinical Trials in Pregnancy and Lactation v1, effective 1 June 2026] New guideline. Pregnant/breastfeeding women should be included in trials where safety data permit; clinical data in non-pregnant participants is required before extending to pregnant participants. Where trial-required contraception fails, the participant continues in the study (no further IP unless a positive risk-benefit is shown) and the baby is followed up for at least 18 months. Child health records are retained until the child's 21st birthday. Breastmilk is classified as human tissue (National Health Act 61 of 2003): export requires an export licence and material transfer agreement, and sample storage is capped at 15 years unless scientifically justified.
The full SAHPGL-CEM-CT series also covers electronic submission of CT documents (CT-01), emergency procedures at trial sites (CT-03), oversight and monitoring (CT-04), consultation meetings with applicants (CT-06), post-clinical-trial access (CT-07), capacity building (CT-08), CT investigators (CT-09) and safety reporting during trials (CT-10).
[OFFICIAL -- SAHPRA Guideline for Remuneration of Volunteers in Phase 1 Clinical Trials v1, effective 1 June 2026] First dedicated Phase 1 healthy-volunteer compensation policy (Phase 2-4 already covered by the 2022 TIE model). Time/Inconvenience/Expense (TIE) model: time R100/hour (standard ~3h visit = R300), travel R4.75/km return trip, meal R100. Minimum standard Phase 1 participant visit (0-25 km) = R650; 26-50 km = R900; over 50 km = R900 + R4.75/km. In-patient confinement: R150/hour for the first 12 hours (R1,800), then R900 per subsequent 12-hour block (24h stay = R2,700; 48h = R4,500; 72h = R6,300). Telephonic visit min R250; home/virtual visit min R300; patient diary entry R100-R150. Completed screening failure paid in full; partial screen failure 20-50%. Excludes gene-transfer-therapy trials (case-by-case).
CLINICAL TRIAL OPERATIONS [OFFICIAL]: New CT applications, protocol amendments, additional investigators/sites, bioequivalence studies, notifications and individual SAEs are submitted electronically to dedicated SAHPRA Clinical Trials Unit mailboxes (SAHPGL-CEM-CT-01 v3). Public Health Emergency clinical trial applications are expedited with a response within 10 working days. POST-TRIAL ACCESS [OFFICIAL -- SAHPGL-CEM-CT-07 v4]: where a Phase III investigational product shows objective, endpoint-based benefit and no marketed standard of care exists in South Africa, the sponsor must provide post-trial access / continued access for a recommended minimum of 4 years after study completion (not applicable to Phase I, II or IV studies).

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SECTION 4B: SECTION 21 ACCESS, CANNABIS, LABELLING, FDC, TRACEABILITY
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SECTION 21 ACCESS TO UNREGISTERED MEDICINES [OFFICIAL -- SAHPGL-CEM-S21-02 v6, 30 October 2025]
Section 21 of the Medicines Act allows access to unregistered medicines for human use. Six access scenarios: (1) individual named patient; (2) multiple patient applications held by a health establishment / medical practice (this replaced the former "bulk stock" route); (3) state procurement; (4) public health emergency; (5) medicines authorised by an MRA recognised by SAHPRA; (6) medicines not authorised by any recognised MRA.
Applications are submitted through the SAHPRA portal; the applicant must have a designated SAHPRA Manufacturing/Import/Export licence holder. After-hours applications are accommodated.
A named-patient application requires an outcome report within 6 months of approval; failure to submit blocks further Section 21 requests. A progress report is due 30 days after completion or termination of use. Adverse drug reactions must be reported within 15 days (non-fatal, non-life-threatening) and sooner for serious/fatal cases.

CANNABIS CULTIVATION AND CANNABIS-RELATED PRODUCTS [OFFICIAL -- SAHPGL-INSP-RC-13 v3, 10 November 2022]
Cultivation of cannabis and manufacture of cannabis-related pharmaceutical products for medicinal/research purposes requires TWO authorisations: (1) a licence from SAHPRA and (2) a permit from the Director-General of Health.
Applicants must meet "fit and proper" requirements, stringent security (including CCTV), and comply with GACP, GLP and GMP. Access to unregistered cannabis-containing products for medicinal use is via Section 21. SAHPRA conducts cannabis-cultivation inspections (billed at R1,600/hour/inspector).

MEDICINE LABELLING [OFFICIAL -- SAHPGL-PEM-05 v1, effective November 2025]
Applies to Category A and D human medicines. The label is the agreed outcome of the assessment process and cannot be changed without SAHPRA approval. Applications must include the label, full-colour digital mock-ups (3D presentation of outer + immediate packaging) and, where relevant, specimen samples. Labels must appear in English plus at least one other official South African language. Related guidelines: Scheduling (SAHPGL-CEM-NS-02), Proprietary Names (SAHPGL-CEM-NS-03), Professional Information (SAHPGL-CEM-02), Patient Information Leaflet (SAHPGL-CEM-03).
MEDICINE ADVERTISING [OFFICIAL -- SAHPGL-INSP-RC-07 v2, June 2022] An advertisement may not deviate from, conflict with or go beyond the approved professional information (Regulation 42(4)). Schedule 0 and Schedule 1 medicines may be advertised directly to the public; Schedule 2-6 medicines may be advertised ONLY to healthcare professionals and only in publications normally restricted to them (price/name/pack-size/strength information to the public is allowed if no registered indication is inferred). An unregistered medicine may not be advertised for sale except with the disclaimer that it has not been evaluated by SAHPRA. A written advertisement must show the proprietary name, the approved active-ingredient names/quantities, and the registration number (or the section 14 reference number). Non-compliant advertising is an offence under the Medicines Act.

FIXED-DOSE COMBINATIONS AND CO-PACKAGING [OFFICIAL -- SAHPGL-CEM-PRE-02 v2 and SAHPGL-CEM-PRE-01 v1]
A dedicated FDC guideline (SAHPGL-CEM-PRE-02 v2) governs fixed-dose combination products for HIV/AIDS, tuberculosis and malaria. Co-packaging of medicines is covered by SAHPGL-CEM-PRE-01 v1.

TRACEABILITY [OFFICIAL -- SAHPGL-INSP-RC-04 v1, October 2025]
SAHPRA has introduced a Guideline on Traceability of Health Products requiring unique identification of health products, with phased compliance effective dates by product category.

RESPONDING TO INSPECTIONS AND RECALLS [OFFICIAL -- SAHPGL-INSP-05 v2; SAHPGL-INSP-RC-05 v4]
A company must submit its response to a GMP/GWP/GCP/GVP inspection report within 30 calendar days (an extension may be requested). For a medicine recall, an interim effectiveness report is required and a final report within 30 days of the recall being instituted.
POST-IMPORTATION TESTING EXEMPTION [OFFICIAL -- SAHPGL-INSP-01 v5]: an approved exemption from post-importation testing is valid for 1 to 3 years.

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SECTION 5: POST-MARKET / PHARMACOVIGILANCE
==============================================================
SAHPRA pharmacovigilance mandatory for all registered products.
Serious adverse events: reported via CIOMS Form, SAHPRA form, or E2B electronic (from Dec 2025).
Recall/withdrawal guideline published and regularly updated.
Annual retention fees must be paid to maintain registration.
Variation types: Type IA (minor), Type IB (moderate), Type II (major) -- per SAHPRA Variations Addendum.

PHARMACOVIGILANCE REPORTING TIMELINES [OFFICIAL -- SAHPGL-CEM-PV-04 v10, September 2025; SAHPGL-CEM-PV-02 v2]
Medication errors: reported to SAHPRA within 15 calendar days (whether serious or not). PSURs/PBRERs: submitted within 30 calendar days of an Authority request, or within 30 calendar days of receipt from the parent company. The Pharmacovigilance System Master File (PSMF) must be made available to SAHPRA within 14 calendar days of a request. A PSMF and a qualified pharmacovigilance person are required. Related guidance: CEM-PV-02 v2 (Pharmacovigilance Systems), CEM-PV-01 (PV Inspections), CEM-PV-03 (Risk Management Plans), CEM-PV-05 (handling Dear Healthcare Professional letters).
HEALTHCARE-PROFESSIONAL ADR REPORTING [OFFICIAL -- SAHPGL-CEM-PV-06 v4, 30 June 2025] Healthcare professionals must report suspected adverse drug reactions and product quality problems under Regulation 40. Reporting timelines: SERIOUS ADRs within 24 hours of identification; non-serious ADRs within 15 calendar days. Channels: the Med Safety App (SAHPRA-preferred), the eReporting link to VigiFlow, or the ADR and Quality Problem form to adr@sahpra.org.za. Reports flow to the WHO VigiBase via VigiFlow; the Pharmacovigilance Advisory Committee advises on regulatory action (label change, withdrawal, DHCPL, up-scheduling).
RISK MANAGEMENT PLANS [OFFICIAL -- SAHPGL-CEM-PV-03 v1, September 2022] A Risk Management Plan (RMP) is submitted as eCTD module 1.13. An RMP is REQUIRED with new registrations of new chemical entities, new biological entities, biosimilars, radiopharmaceuticals, generics submitted with clinical data, and any product returning to market after a safety withdrawal; and with a major (Type II) variation that creates a new or heightened risk (new target population, higher-risk route, changed indication). Not routinely required for standard generics or Type IA/IB variations. The EU RMP format is accepted but a South Africa-Specific Annexure (SASA) is required, covering SA epidemiology, exposure data and any divergence between the EU SmPC and the SAHPRA-approved Professional Information. RMPs requested by SAHPRA must be submitted within 90 calendar days; routine pharmacovigilance still applies even when no RMP is required.
REGULATOR POST-MARKET QUALITY SURVEILLANCE [OFFICIAL -- SAHPGL-INSP-RC-01 v3, 27 July 2023] Separate from manufacturer pharmacovigilance, SAHPRA runs its own post-marketing surveillance (PMS) programme -- risk-based sampling of medicines and health products from across the supply chain (importer warehouses, wholesalers, retail pharmacies/hospitals, formal and informal retail) and quality testing at a WHO-prequalified or ISO 17025 laboratory to detect substandard and falsified products. Out-of-specification results can trigger close monitoring, recall or withdrawal, cancellation of registration, and suspension or revocation of the Section 22C licence, plus penalties under the Medicines Act. Results may be shared with ZAZIBONA and SADC partners.
CLINICAL TRIAL SAFETY REPORTING [OFFICIAL -- SAHPGL-CEM-CT-10 v5]: a SUSAR preliminary report must reach SAHPRA within 7 calendar days of first knowledge; final / follow-up reports within 30 days of being finalised.

APPEALS AGAINST REGULATORY DECISIONS [OFFICIAL -- SAHPGL-LEG-01 v3, June 2025]
An applicant may appeal a SAHPRA regulatory decision by notifying the CEO within 30 days of becoming aware of the decision. The CEO must convene to hear the matter within 30 days; the Appeal Committee must hear and decide within 30 days of its first meeting (Section 24A of the Medicines Act).

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SECTION 5B: VETERINARY MEDICINES & RADIATION CONTROL
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VETERINARY MEDICINES [OFFICIAL -- SAHPGL-PEM-VET-04 v4, 27 June 2023]
Veterinary medicines are registered under the Medicines Act via a CTD dossier; a unit-pack sample is required (Section 15(1)). Review allows a maximum of 3 response rounds; each response is due within 30 working days, with one extension per round (up to a further 30 working days) on scientific justification; failure to respond leads to rejection. No variations are permitted during the registration process except Transfer of Applicancy, urgent safety restrictions, or updated reliance documentation. Overseas manufacturers without acceptable GMP evidence are inspected by the SA GMP Inspectorate before registration. Renewals follow SAHPGL-HPA-04. Related: PEM-VET-01 (access to unregistered veterinary medicines), PEM-VET-02 (veterinary clinical guideline), PEM-VET-03 (exemptions from certain registration requirements).

RADIATION CONTROL -- SEPARATE LEGAL REGIME [OFFICIAL -- SAHPGL-RDN-XR-24 v1, SAHPGL-RDN-XR-26 v2, SAHPGL-RDN-XR-27 v1, SAHPGL-RDN-INSP-01 v2]
IMPORTANT: radiation-emitting medical devices and radioactive sources are NOT regulated under the Medicines Act. They fall under the HAZARDOUS SUBSTANCES ACT, 1973 (Act 15 of 1973), administered by SAHPRA's Radiation Control unit. Devices are classed as Group III hazardous substances (electronic products producing radiation -- e.g. X-ray, CT) and Group IV hazardous substances (radioactive material). Key regulations: R247 of 1993 (Group IV) and R1332 of 2003.
Importing an electronic device emitting ionising radiation requires an IMPORT LICENCE under the Hazardous Substances Act (SAHPGL-RDN-XR-24). Possession/use requires an authority-holder licence. A manufacturer or importer of X-ray, CT, radiotherapy or nuclear-medicine equipment must therefore deal with Radiation Control SEPARATELY from any Medicines-Act medical-device establishment licensing. Numerous operational codes of practice exist for end-users (SAHPGL-RDN-XR and SAHPGL-RDN-RN series). Newer guidelines: SAHPGL-RDN-NM-06 v1 (MRI licensing) and SAHPGL-RDN-NM-01 v1 (non-ionising radiation device licensing), both Feb 2026; SAHPGL-RDN-XR-27 v1 (Nov 2025, ultra-portable X-ray equipment).

NIRMED LICENSING TIMELINES [OFFICIAL]: A device emitting non-ionising radiation (laser, ultrasound, RF, MRI) is a Group III hazardous substance / listed electronic product regulated by SAHPRA NIRMED under the Hazardous Substances Act 15 of 1973.
[OFFICIAL -- SAHPGL-RDN-NM-01 v1, effective 15 January 2026: Licence Applications for Non-Ionising Radiation Medical and Non-Medical Listed Electronic Products] Import/manufacture licence applications use forms GLF-RDN-NM-01A/B/C/D, require an EU Notified Body certificate plus Declaration of Conformity, and have a 50-working-day turnaround; submit to nirmed.application@sahpra.org.za.
[OFFICIAL -- SAHPGL-RDN-NM-06 v1, effective 2026: MRI Install/Use Licence] An MRI system must FIRST be licensed for import or manufacture; only then is a separate install/use licence technically evaluated (60 working days). Use licence valid 5 years, renewable within 90 working days before expiry.

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SECTION 6: KEY TIMELINES
==============================================================
[FIELD] SAHPRA historically had massive backlog (16,000+ applications by 2018). Backlog clearance project (BCP) 2019-2022 with Bill & Melinda Gates Foundation funding.
[FIELD] Current timelines improving. Standard generic: 12-24 months. NCE: 18-36 months. Priority/reliance: potentially faster.
[FIELD] Risk-based assessment pilot showed significant timeline improvements.
[FIELD] Medical device establishment licences: variable processing time, 3-12 months typical.

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GUIDELINE INDEX
==============================================================
SAHPRA COMPLETE GUIDELINE INDEX (sahpra.org.za/guidelines/, verified April 2026):
ICH and VICH aligned. Document numbers prefixed SAHPGL-.

ORTHODOX MEDICINES (Human Medicines Evaluation):
- SAHPGL-HPA-07 v13 (Sep 2025): General Information Guideline -- master reference for all medicine registrations
- SAHPGL-BAU-01 v6 (Dec 2025): Reliance Guideline -- defines abridged/verified/recognition pathways [INTEGRATED]
- SAHPGL-HPA-09 v4 (Oct 2025): eCTD Specification 3.1 and Module 1 Guidance -- SA-specific Module 1 requirements
- SAHPGL-PEM-05 v1 (Oct 2025): Labelling of Medicines Intended for Human Use
- SAHPGL-CEM-02 v6 (Apr 2024): Professional Information (PI) for Human Medicines (Categories A and D) [INTEGRATED]
- SAHPGL-CRO-02 v1 (Jul 2024): Co-Applicancy Guideline -- rules for co-applicants/Section 22C holders
- SAHPGL-PEM-02 v9 (Oct 2025): Quality and Bioequivalence Guideline (formerly 2.02) -- adopts EMA quality/BE guidelines with SA-specific addenda. Reliance applicable for both new registrations and Type I/II variations. Excipient specs must be signed, dated, version controlled.
- 2.09 v2 (Jul 2019): Clinical Guideline -- defines full vs abridged review criteria for clinical data [INTEGRATED]
- 2.04 (archived): Dissolution Guideline
- 2.05: Stability Guideline -- SAHPRA-specific requirements (ICH Q1A/Q1C/Q1E aligned)
- SAHPGL-HPA-06 v7 (Sep 2025): Variations Addendum for Human and Veterinary Medicines -- covers Type IA/IB/II classification, reliance for variations, USRN urgent safety procedures
- GLF-HPA-06ZZZ v1: Annexure C -- CEM Clinical Variations Classification Codes
- Priority Review: HPA03-202223 communication (expedited for unmet medical need)
- PHE Medicines: SAHPGL-PEM-01 (public health emergency pathway)

BIOLOGICALS | BLOOD | VACCINES (BMERU):
- Dedicated BMERU guidelines, forms and communication
- Lot release system: medapps.sahpra.org.za:6006/LR
- National Control Laboratory for biological lot release

COMPLEMENTARY MEDICINES:
- Dedicated portal: sahpracm.org.za/catd/
- Separate registration pathway and scheduling framework from orthodox
- Health supplements, traditional medicines, complements

CLINICAL TRIALS:
- SA Good Clinical Practice Guidelines (SA-specific, not just ICH E6)
- CTF1 application form required
- All investigators: SA-registered, GCP-trained, SA-resident
- Liability insurance and professional indemnity mandatory
- HREC approval required (parallel with SAHPRA but SAHPRA finalises only after HREC)
- Clinical Trials Committee submission dates published annually

MEDICAL DEVICES AND IVDs:
- SAHPGL-MD-22 v1 (Feb 2026): Medical Devices Reliance Guideline -- reliance, recognition, verification pathways [INTEGRATED]
- SAHPGL-MD-18 v1 (Sep 2025): Post-Market Surveillance and Post-Market Clinical Follow-Up Studies
- SAHPGL-MD-16 v1 (Sep 2025): Clinical Evaluation of Medical Devices
- SAHPGL-MD-17 v1 (Sep 2025): Clinical Investigation of Medical Devices
- SAHPGL-MD-11 v1 (Dec 2024): Adverse Event Reporting Form for Device Licence Holders
- GLF-MD-11A v1 (Dec 2024): Medical Device Adverse Event Reporting Form
- 8.04 v2 (Nov 2019, archived): Recalls Vigilance Medical Devices/IVDs
- WHO CRP: sahpra.org.za/who-collaborative-procedure-for-accelerated-registration-who-crp/
- Conformity Assessment Bodies: sahpra.org.za/list-of-recognised-conformity-assessment-bodies/

INSPECTIONS | LICENCES | COMPLIANCE:
- SAHPGL-INSP-GMP-02 v1 (Oct 2025): GMP Guide for APIs (Q7 aligned)
- SAHPGL-INSP-RC-03 v3 (Nov 2025): Destruction of Medicines and Scheduled Substances
- SAHPGL-INSP-RC-04 v1 (Oct 2025): Traceability of Health Products
- SAHPGL-LIC-05 v2 (March 2026): Import/Distribute Scheduled Substances (supersedes v1 Apr 2024 GWP for Importers/Distributors)
- Licensed establishments database: sahpra.org.za/approved-licences/
- Revoked/suspended pharma licences published

NAMES AND SCHEDULING:
- Consolidated Schedules (Aug 2025 edition)
- S0-S8 scheduling system

VETERINARY:
- SAHPGL-PEM-VET-04: General Information for Veterinary Medicines Registration
- Separate portal, registered products database

RADIATION CONTROL:
- SAHPGL-RDN-NM-06 v1 (Feb 2026): MRI licensing
- SAHPGL-RDN-NM-01 v1 (Feb 2026): Non-ionising radiation device licensing
- Multiple X-ray and radiation source guidelines (SAHPGL-RDN-XR series)
- SAHPGL-RDN-INSP-01 v2 (Nov 2024): Sealing/unsealing hazardous substances

SECTION 21 (UNREGISTERED PRODUCTS):
- Category A medicines via Engagement Portal
- Medical devices, complementary, and veterinary unregistered product access pathways

PV AND SAFETY:
- Med Safety App: medsafety.sahpra.org.za
- ADR reporting via WHO VigiFlow
- Health Product Vigilance unit
- Product recalls, rapid alerts, safety alerts published
- Mpox monitoring portal active

DIGITAL PLATFORMS:
- eCTD Submissions Portal: ectd.sahpra.org.za
- Engagement Portal: portal.sahpra.org.za
- Variations Portal: variations.sahpra.org.za/portal/
- Application Status Checker: sahpra.org.za/application-status-checker/
- Variations Status Checker: sahpra.org.za/variations-status-checker/
- Service Desk: service.sahpra.org.za
- OTC Medicines Directory: medsinfo.sahpra.org.za
- PI/PIL Repository: pi-pil-repository.sahpra.org.za
- Registered Health Products database: medapps.sahpra.org.za:6006
- Lot Release Search: medapps.sahpra.org.za:6006/LR

Source: https://www.sahpra.org.za/guidelines/

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SHAAMI GHANA REGULATORY KNOWLEDGE BASE -- GHANA FDA
Regulator: Food and Drugs Authority (FDA Ghana)
Legal basis: Public Health Act, 2012 (Act 851), Parts 6, 7 and 8
Address: P.O. Box CT 2783, Cantonments, Accra, Ghana | GPS: GA-237-7316
Tel: (+233)302-233200/235100 | Website: www.fdaghana.gov.gh
Portal: verifypermit.fdaghana.gov.gh (product registry); G-FIRMS gfirms.fdaghana.gov.gh
NRA maturity: WHO Maturity Level 3 (achieved). Established 1997
Sources: FDA Ghana Guidelines 2024, L.I. 2481 fee schedule, secondary sources
Last updated: April 2026
==============================================================

REGULATOR AND PORTALS
- Applications submitted via hardcopy and in-person electronic (text-selectable PDF)
- No eCTD submission yet -- physical submission at FDA office or via local agent
- No online application tracking -- must visit physically to check status
- Registration valid: 5 years (standard for medicines), renewable
- Dossier format: CTD (ICH M4)
- Product registry: verifypermit.fdaghana.gov.gh/publicsearch ; G-FIRMS portal: gfirms.fdaghana.gov.gh/irims-portal-live

LOCAL REPRESENTATIVE
Foreign manufacturers must appoint a local authorised representative in Ghana. Must be a corporate entity legally registered in Ghana. Mandated by applicant via Power of Attorney.

1.1 REGISTRATION PATHWAYS
Standard (FIFO) -- Full CTD review. Assessment on first-in-first-out basis.
Fast Track -- For products classified for fast track processing (WHO-PQ, SRA-approved, essential medicines, public health priority). Guideline published 2024.
WHO Collaborative Registration Procedure (CRP) -- Ghana FDA participates. FDA focal person coordinates with WHO-PQ for product-specific information sharing.
EAC-MRH -- Ghana is not a member but cooperates with ECOWAS harmonisation efforts.
[FIELD] Drug registration timeline: approximately 3 months for first-time, 2 months for renewal (optimistic estimates from published sources). In practice, 6-12 months more realistic.
[OFFICIAL -- FDA Ghana Guideline on Registration of Allopathic Drugs, FDA/DNC/GDL-01/03 v02, effective 8 January 2024] The core human-medicine registration guideline: full CTD structure (Module 1 administrative and prescribing information through Module 5 clinical), aligned with WHO and ICH; a companion Quality Part guideline details the Module 3 quality requirements.

1.2 DOSSIER REQUIREMENTS
- FDA application form (declaration signed by applicant)
- Separate application per product (different active ingredients, strengths, dosage forms, or proprietary names)
- One application sufficient for same product differing only in packaging/pack sizes
- Electronic copies + product samples + reference standards
- Application fee + inspection fee
- Certificate of Analysis for API and FPP (minimum 3 batches)
- GMP certificate of manufacturer
- Shelf life compliance per FDA importation guidelines
- For generics: BE study or biowaiver data
- For new chemical entities: clinical trial data required

1.3 FAST-TRACK PROCESSING
[OFFICIAL -- FDA/DNC/GDL-06/02 v02, 8 January 2024] Three categories eligible for expedited 90 calendar day processing:
(a) WHO Prequalified Products: dossier must be identical to current WHO-PQP version. Country-specific additions: executed batch manufacturing records, Zone IVB stability, QIS copy. FDA decision within 90 calendar days. Post-approval: all WHO post-PQ variations submitted simultaneously to FDA.
(b) Program Drugs (MoH programmes): ARVs, anti-malaria, TB drugs, reproductive health products, neglected tropical disease drugs. Full review at standard evaluation depth. 90 calendar days.
(c) SRA Registered Drugs: valid marketing authorisation from ICH member (pre-2015). Limited review (risk-based approach). 90 calendar days.
All categories: full dossier required, application fees payable, registration samples required.

1.4 FEES -- MEDICINES (L.I. 2481)
[OFFICIAL -- L.I. 2481, Fees and Charges (Miscellaneous Provisions) Regulations, 2023]
All imported product fees in USD equivalent (paid in GHS at current rate). Local fees in GHS.
REGISTRATION/RE-REGISTRATION (per annum, imported): Allopathic medicinal products USD 240; Allopathic new chemical products USD 360; Herbal products USD 240; Veterinary products USD 120; Orphan drugs USD 60; Biological products USD 360; Lot release vaccines/plasma-derived (per lot) USD 500.
REGISTRATION (locally manufactured, GHS per annum): Allopathic GHS 1,000 / Small scale GHS 200; Veterinary GHS 300; Herbal GHS 500; Orphan GHS 200; Biological GHS 500.
MEDICAL DEVICES (imported, per annum): Class I USD 60 / Class II USD 100 / Class III USD 160 / Class IV USD 200. One-time import USD 2,875. SaMD USD 100 / SaMD upgrade Class II-IV USD 50. Locally manufactured: Class I GHS 750, Class II GHS 900, Class III GHS 1,050, Class IV GHS 1,200.
IVD REAGENTS (imported, per annum, per item): Class I 10-30 items USD 35, 31-300 USD 25, 301-500 USD 16; Class II 10-30 USD 60, 31-300 USD 35, 301-500 USD 25; Class III-IV 10-30 USD 95, 31-300 USD 55, 301-500 USD 40.
FOOD SUPPLEMENTS (imported, per product per annum): 1-50 products USD 100 / 51-100 USD 70 / >100 USD 60. Locally manufactured GHS 200.
COSMETICS/HOUSEHOLD CHEMICALS (imported, per annum): 1-30 products USD 59 / 31-500 USD 37 / 501-1000 USD 24 / >1000 USD 7.
VARIATIONS (imported): Allopathic/biological major USD 500 / minor USD 300; Device Class I major USD 150 minor USD 70; Device Class II major USD 250 minor USD 120; Device Class III-IV major USD 370 minor USD 190; Food supplement major USD 300 minor USD 150.
VERIFICATION FEES (import, % of FOB value): Food 0.80% / Drugs 1.80% / Medical devices 1.30% / Cosmetics/HCS 0.50% / Food supplements 1.30% / Veterinary 1.30%.
GMP INSPECTIONS: Foreign GMP West Africa USD 6,000 / Rest of Africa USD 8,000 / Outside Africa USD 10,500. Local GMP allopathic: large GHS 3,000, medium GHS 2,000, small GHS 1,000. Scientific advice meeting (foreign) USD 500.

1.5 GMP REQUIREMENTS
GMP audit required for all manufacturing sites. Guideline published.
Minimum documents required at site during audit: Pharmaceutical Quality System, GMP documentation, sanitation/hygiene, qualification/validation, complaints system, recall procedures, self-inspection records.
[FIELD] GMP audit timeline: approximately 3 months first-time, 2 months renewal.
GMP INSPECTION WAIVERS [OFFICIAL -- FDA/DID/NOT-01, effective January 2019]:
On-site cGMP inspection waived for manufacturers from: ICH members (USA, Japan, EU) and TGA (Australia); WHO pre-qualified facilities (must use CRP-WHO for registration).
Required waiver documents: manufacturing authorisation, updated Site Master File (under 1 year old, WHO TRS 961 Annex 14), product list, last inspection report + GMP certificates from local authority/PIC/S/WHO, CAPAs, Annual Product Quality Review (APQR), batch manufacturing records, self-inspection confirmation, list of recalls (3 years).
WARNING: any warning letters or regulatory actions from ANY authority must be disclosed.
Non-ICH/non-WHO-PQ manufacturers: full on-site FDA GMP audit required (~3 months first time, ~2 months renewal).

1.6 CONTROLLED SUBSTANCES
[from FDA/DRI/TSA/GL-ICS/2013/02 v02, Oct 2019] FDA regulates narcotics/psychotropic substances/precursors per UN Conventions (1961/1971/1988).
Import permit required via GCNet electronic system. Annual allocation system based on utilisation records.
Local manufacturers must have at least 5 years manufacturing experience before handling controlled substances.
Controlled substance raw materials cannot be transferred to another manufacturer.
Advice of Receipt: within 2 weeks of import. Returns: submitted quarterly.
Samples: precursors max 25kg, narcotics max 5kg, psychotropics max 25kg.

1.7 DRUG LABELLING
[OFFICIAL -- Guidelines on Labelling of Medicinal Products] Based on EMA Guideline on acceptability of names + FDA guidance on safety design. INN must be used. Brand name criteria reviewed for safety and INN conflicts. Radiopharmaceuticals: target organs should NOT be in brand name.

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SECTION 2: MEDICAL DEVICES & IVDs
==============================================================
FDA Ghana regulates medical devices under Public Health Act 2012.
Classification: Class A-D (risk-based, IMDRF-aligned)
Registration required before import, distribution or sale.
Foreign manufacturers must appoint local agent.
Submission: hardcopy + electronic (PDF), in person at FDA office.
Assessment: FIFO basis with exceptions for public health priority.
Non-refundable registration fee per application.
Product samples may be required.
Device fees per L.I. 2481: Class I USD 60, Class II USD 100, Class III USD 150, Class IV USD 200, SaMD USD 100 (see SECTION 1.4 FEES).
[FIELD] No clear guidance on grouping similar devices under one application.
[OFFICIAL -- FDA/MCH/MDD/GL-RMD/2013/01 v02, effective Mar 2016] GHTF/IMDRF aligned. Classification per GHTF SG1/N77:2012. 62-page guideline. STED (Summary Technical Documentation) per GHTF/SG1/N011:2008 required. EPSP (Essential Principles of Safety and Performance) compliance + Declaration of Conformity required. QMS documentation mandatory. Clinical evaluation for higher-risk devices. Local agent with legal mandate required for non-resident applicants. Collaboration with Ghana Standards Authority (GSA) for device standards and Nuclear Regulatory Authority for radiation devices. New, renewal, and variation application types defined.
Additional published device guidelines: SaMD registration guideline; Used and refurbished medical equipment guideline (Feb 2024); Donation of medical devices guideline (Sep 2024); Import permit/clearance for cosmetics/devices/household chemicals (Jul 2025).

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SECTION 3: COMPLEMENTARY / HERBAL
==============================================================
FDA Ghana regulates herbal medicines, cosmetics, household chemicals, tobacco products.
Separate registration process for herbal medicines.
Traditional/herbal medicines have specific safety and quality data requirements.
Herbal medicines: assessed in collaboration with Centre for Plant Medicine Research (CPMR) Mampong. Separate Herbal and Homeopathic Medicines Department handles registration.

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SECTION 3B: BIOLOGICALS / VACCINES
==============================================================
BIOLOGICAL PRODUCTS [OFFICIAL -- FDA/SMC/BPD/GL-RBP/2013/01 v02, effective Mar 2019]:
CTD format (5 modules). 61-page guideline.
Covers: GMO products (insulin), traditional vaccines, immunotherapy, peptides/polypeptides, monoclonal antibodies, human cell-based products.
Section 3.5: Reliance pathway explicitly referenced. Risk Management Plan (RMP) mandatory.
Standard timeline: 260 working days. Verification pathway: 30 working days.
VACCINE/BIOLOGICAL LOT RELEASE [from Guideline on Lot Release, Jun 2025]:
Three lot release pathways: (a) Routine/Full -- complete independent review of Lot Summary Protocol (LSP); (b) Non-routine (Reliance) -- reliance on lot release certificate from country of origin NRA or regional authority; (c) Non-routine (Exceptional/Expedited) -- for public health emergencies.
Risk-based methodology for lot release categorisation. LSP templates: EDQM OCABR guidelines or WHO TRS model protocols.
Cold-chain verification: FDA inspects consignment within 2 days of arrival. Temperature monitoring device required for whole journey.
Timeline: 30 working days for lot release. Applies to ALL vaccines/biologicals including self-procurement, UN agency supply, and public health emergency procurement.
Non-conforming lots: corrective actions or rejection. Non-compliant/rejected lots safely disposed or returned to origin.
BIOSIMILAR PRODUCTS [OFFICIAL -- FDA/VBP/GDL-02/03 v03, effective 5 September 2025]:
55-page guideline. WHO-acknowledged. Now under Vaccines, Vigilance and Clinical Trials Directorate.
ICH Q5A-E aligned + EMA biosimilar guidelines (EMEA/CHMP/437/04). Biosimilarity demonstration mandatory.
Data required: analytical (physicochemical + functional), animal toxicity studies, clinical (immunogenicity + PK/PD).
Full DMF required (Type II DMF NOT sufficient). Manufacturing process validation protocol + report required.
GMP and GLP certificates required for manufacturing and validation facilities.
Section 3.4: Reliance pathway available (references FDA Reliance Policy).
Section 5.0: specific provisions for imported biosimilars.
Variation must be approved BEFORE importation of varied biosimilar.
Post-market surveillance/PV plan mandatory.
NAMED PATIENT ACCESS [FDA/VBP/GDL-12/02, Sep 2025]: Guideline for importation of unregistered biological product for named patient. Allows access to unregistered biologicals when no registered alternative exists.
BIOLOGICAL VARIATIONS [FDA/SMC/BPU/GL-VAR/2015/07]: Detailed classification covering cell bank changes, seed lot changes, manufacturing facility changes, bulk/final product process changes, excipient changes (biological and non-biological), QC testing changes, specification changes, diluent changes, adjuvant changes.
BIOLOGICALS FEES (from L.I. 2481 Fee Schedule): Imported biological products registration USD 360/year; imported NCE USD 360/year; lot release (imported, per lot) USD 500; local biological products registration GHS 500/year; local lot release GHS 2,000/lot; local orphan drugs GHS 200/year; local small-scale manufacturers GHS 200/year.

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SECTION 4: CLINICAL TRIALS
==============================================================
FDA Ghana regulates clinical trials under Act 851.
Approval required before conducting trials.
GCP compliance mandatory.
Clinical trial authorization: 60 working days standard. Reliance pathway available if trial/product already authorized by reference NRA or reviewed under AVAREF.
Guideline for Authorization of Clinical Trials of Medicines and Food Supplements published.

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SECTION 5: POST-MARKET / PHARMACOVIGILANCE
==============================================================
Pharmacovigilance: adverse event reporting required.
Post-market surveillance conducted.
Pharmaceutical traceability guideline under development (GS1 standards).
Blood and blood products regulation strengthened (collaboration with Paul-Ehrlich-Institut).
FDA Ghana publishes guidelines for conducting GPVP (good pharmacovigilance practice) inspections.

==============================================================
SECTION 6: KEY TIMELINES
==============================================================
[FIELD] Medicines registration: 3-12 months depending on pathway and completeness.
[FIELD] Fast track (WHO-PQ/SRA): potentially under 6 months.
[FIELD] Pre-submission consultation available and recommended.
MEDICINAL PRODUCT REGISTRATION TIMELINES [OFFICIAL -- Process Flow and Timelines, DNC Department, Sep 2024]:
Clock system (stops when FDA requests further info).
Week 0: Receipt at client service, pre-evaluation assessment, fees paid
Week 4: Acknowledgement, classification, application number assigned
Weeks 10-16: Evaluation (quality/safety/efficacy) + lab analysis of registration samples
Weeks 16-20: Registration committee meeting + GMP audit report review
Weeks 20-22: Decision communicated to applicant
TOTAL: ~22 weeks (~5.5 months) for standard straightforward application.
IF DEFERRED: response deadline 12 months (1st), 6 months (2nd), 3 months (3rd). Reassessment: 16 weeks from query response.
APPEAL: 60 days from rejection decision (Section 118(6) of Public Health Act 2012, Act 851).

==============================================================
GUIDELINE INDEX
==============================================================
GUIDELINE INDEX (fdaghana.gov.gh):
- Allopathic drugs registration (CTD, FDA/DNC/GDL-01-03)
- Biological products registration (FDA/SMC/BPD/GL-RBP/2013/01)
- Medical devices registration (FDA/MCH/MDD/GL-RMD/2013/01)
- SaMD registration
- Reliance Policy (FDA/GEN/POL-02)
- Process flows and timelines for registration, re-registration, variations
- Guideline on variations
- Drug labelling guidelines
- GMP audit guideline (~3 months 1st time, ~2 months renewal)
- Clinical trials authorization (2024)
- Used/refurbished equipment, donated devices, import clearance
- Product registry: verifypermit.fdaghana.gov.gh/publicsearch
- G-FIRMS portal: gfirms.fdaghana.gov.gh/irims-portal-live
[OFFICIAL] FDA Ghana's current published guideline suite also includes: Guidelines for Reporting Variations; Guidelines on Parallel Importation of Medicinal Products; Guideline for Registration of Software as a Medical Device; Guideline for Importation of Medical Devices and for Used and Refurbished Medical Equipment; Guidelines on Registration of Veterinary Medicinal Products; the FDA Reliance Guideline on Regulatory Decision-Making; guidelines for conducting GPVP (good pharmacovigilance practice) inspections and cGMP inspection of herbal manufacturers; and the Guideline for Authorization of Clinical Trials of Medicines and Food Supplements.

==============================================================
SHAAMI RWANDA REGULATORY KNOWLEDGE BASE -- RWANDA FDA
Regulator: Rwanda Food and Drugs Authority (Rwanda FDA)
Legal basis: Law No. 003/2018 of 09/02/2018
Address: P.O. Box 1948, Kigali, Rwanda | Email: info@rwandafda.gov.rw
Website: www.rwandafda.gov.rw | Portal: PRIMS / iRIMS (product registration, import visa, import licences)
NRA maturity: WHO Maturity Level 3 (achieved December 2024)
Director General: Dr. Emile Bienvenu
Sources: Rwanda FDA Guidelines 2024, abbreviated procedure guidelines, secondary sources
Last updated: April 2026
==============================================================

REGULATOR AND PORTALS
- PRIMS portal for online submissions (medicines, import visa, import licences)
- Rwanda FDA mandates: human and veterinary medicines, vaccines, biologicals, processed foods, poisons, medicated cosmetics, medical devices, household chemicals, tobacco
- Registration valid: 5 years, renewable
- EAC (East African Community) member -- participates in EAC-MRH joint assessments
DIGITAL PLATFORMS:
- iRIMS (Integrated Regulatory Information Management System) for submissions
- Rwanda FDA e-Learning Platform
- Product registry, SmPC/PIL repositories, GMP/GDP-compliant premises lists published

LOCAL REPRESENTATIVE
Foreign manufacturers must appoint a local representative (Marketing Authorisation Holder). The applicant/owner of the product may be the manufacturer or a person to whose order the product is manufactured.

==============================================================
SECTION 1: MEDICINES (HUMAN)
==============================================================
Guideline: DD/HMDR/GDL/001 Rev 1 (Guidelines for Registration of Human Pharmaceutical Products)
Dossier: CTD format
Stability: Zone IVb
Pharmacopoeias: Ph. Int., Ph. Eur., BP, JP, USP accepted

1.1 REGISTRATION PATHWAYS
Full Assessment -- Full CTD dossier evaluation.
Abbreviated Procedure -- DD/HMDR/GDL/004 Version 3 (effective 15 August 2024). Domesticated from EAC joint assessment abridged procedures. For products approved by recognised reference regulatory authorities, trusted institutions, and regulatory authorities of recognised competence. Risk-based approach to avoid duplication.
EAC Mutual Recognition Procedure (EAC-MRP) -- Regional harmonisation pathway.
WHO Collaborative Registration Procedure (CRP) -- Rwanda FDA participates.
[FIELD] Rwanda has been praised for implementing regional regulatory reliance -- reportedly increased access to quality medicines by 40% and reduced regulatory costs by 35%.

1.2 RELIANCE
[OFFICIAL -- ODG/RAHC/GDL/001 Rev_3, February 2024: Reliance Guideline]
Scope: all medical products -- MA, GMP/GCP inspections, clinical trials, vigilance, PMS, QC testing.
REFERENCE AUTHORITIES FOR MA RELIANCE:
(a) WHO Prequalified Products (incl WHO PQ collaborative procedure)
(b) Stringent Regulatory Authorities (SRAs)
(c) WHO Listed Authorities (WLAs) and WHO transitional Listed Authorities (category B)
(d) Continental/regional: EMA and EAC joint dossier assessments
(e) ML3 functioning regulatory authorities with MoU with Rwanda FDA
NOTE: Rev_2 expanded from ICH-only to all WHO transitional listed authorities -- significantly broader.
FOUR RELIANCE PATHWAYS:
(a) Verification of sameness | (b) Confirmation of applicability for national context
(c) Abridged assessment using RRA reports | (d) Joint assessment/work-sharing
GMP reliance: waivers for WLA/WHO transitional listed (cat B), PIC/S members, WHO PQ-inspected facilities.
QC testing reliance: accepted from WHO PQ or accredited labs.
Reliance: unilateral, bilateral, or multilateral. Authority retains sovereignty and accountability.

1.3 SCREENING AND ASSESSMENT PROCESS
Application received via PRIMS portal.
Screening for completeness within 30 calendar days.
If incomplete: applicant notified, not scheduled for assessment.
Queries: applicant must respond in one submission with all outstanding info. Reissued queries for second time with unsatisfactory responses = rejection.
cGMP inspection is part of product registration process -- no product registered without GMP verification.
[OFFICIAL -- DD/HMDR/GDL/001 Rev_1, February 2024: Registration of Human Pharmaceutical Products]
205-page CTD guideline. Aligned with EAC Compendium + WHO + ICH.
Recognised pharmacopoeias: Ph.Int., Ph.Eur., BP, JP, USP.
CEP or APIMF accepted for API quality. WHO PQ evidence accepted.
Registration status in EAC and SRAs/WLAs must be declared.
Registration Committee decision: approve, reject, or request additional data.
Certificate of registration (Annex-X) issued upon approval, valid 5 years.

1.4 FEES -- MEDICINES
[OFFICIAL -- CBD/TRG/004 Rev_2, Rwanda FDA Regulatory Service Tariff/Fees and Fines, March 2021]
Fees in USD (foreign) or FRW (domestic). Payment via PRIMS. Non-refundable.
REGISTRATION (5-year validity):
Human medicines (foreign imported): USD 1,250
Veterinary medicines (foreign): USD 600
Herbal medicines (foreign): USD 250
Human medicines (domestic): FRW 300,000
Veterinary medicines (domestic): FRW 200,000
Herbal medicines (domestic): FRW 50,000
MEDICAL DEVICES (foreign): Class A USD 500 / Class B USD 1,500 / Class C USD 2,000 / Class D USD 2,500. Variants (same manufacturer, same model, slight differences): 5% of registration fee.
MEDICAL DEVICES (domestic): Class A FRW 100,000 / Class B FRW 120,000 / Class C FRW 200,000 / Class D FRW 220,000
IVDs (foreign): Class A USD 300 / Class B USD 1,000 / Class C USD 1,200 / Class D USD 1,500
IVDs (domestic): Class A FRW 120,000 / Class B FRW 200,000 / Class C FRW 300,000 / Class D FRW 400,000
COSMETICS/HOUSEHOLD CHEMICALS (foreign): Toothpastes USD 250 / Antiseptics USD 150 / Cosmetics USD 250
FOOD SUPPLEMENTS (foreign): USD 700
CLINICAL TRIALS: Phase I USD 4,000 / Phase II USD 4,000 / Phase III USD 3,000. Research institution (foreign) USD 4,000 / (domestic) USD 2,000. Amendment of approved trial USD 500.
RETENTION/RENEWAL: percentage of initial registration fee (per regulation Part 2).
GMP inspection fees: determined based on manufacturing site location (cost recovery).
AMA headquartered in Kigali, Rwanda. Rwanda FDA hosts BioNTech biontainer facility.
MoU with Ghana FDA (Nov 2022) and SAHPRA (Apr 2024) for joint reviews and cooperation.
FEES REGULATION [from CBD/TRG/004 Rev_2]:
Payment in RWF or USD. Non-refundable, non-transferable.
FOB-based import fees calculated on declared value verified by Authority.
Variants (same manufacturer, same ingredients, different additive/packaging): 5% of main product registration fee.
Grouping: products with same base, 2-10 products (85% discount), 11-20 (further discount).
GMP inspection fees: site-based, cost recovery.
Appeals: Article 7. Exemptions: Article 8 (emergency situations).
December 2024 updated fee schedule published (per Rwanda FDA website).

1.5 GMP REQUIREMENTS
[OFFICIAL -- FDISM/FDIC/GDL/001 Rev_4, April 2023: GMP Guidelines for Finished Pharmaceutical Products]
73-page guideline (Part 1) + annexes (Part 2, incl API GMP guide).
cGMP inspection mandatory for all manufacturing sites BEFORE product registration.
Types of inspection: routine, and any type as deemed necessary by Authority.
11 chapters: pharmaceutical QS, personnel, premises/equipment, documentation, production, QC, outsourced services, complaints/recalls, self-inspection.
Key personnel qualifications defined. Classification of inspection findings.
GMP certificate issued upon compliance. Application process defined (Chapter 2.2).
Rwanda FDA may conduct own inspection OR accept reports from recognised authorities (per reliance guideline).
GMP inspection fees: determined by manufacturing site location (cost recovery basis).
[FIELD] Rwanda FDA participates in joint EAC GMP inspections.

1.6 IMPORT / EXPORT
[OFFICIAL -- FDSIM/FDIEC/GDL/001 Rev_1, November 2022]
20-page guideline covering pharma products AND medical devices/IVDs.
Two-phase import process: Import Visa (phase 1, valid 6 months) then Import License (phase 2, valid 6 months, single consignment).
Import visa: confirms manufacturer/supplier compliance with international/national standards.
Import license (DIS/FMT/122): granted for single consignment after visa.
Processing time: 3 working days for export authorisation.
All products must be registered or have special approval before import.
Applications via PRIMS platform. All consignments pass through approved port of entry.
Min 2/3 shelf life remaining at port of entry. Product info in officially recognised Rwandan languages.
Physical inspection at port of entry or importer's premises (sealed consignments).
ELIGIBLE IMPORTERS: licensed manufacturers and wholesalers only.
REGISTERED PRODUCTS: GMP/ISO/IEC/CE certificates NOT required for import visa (simplified in Rev_1).
NON-REGISTERED PRODUCTS: COA not required if manufacturer in SRA country. GDP/operational licence can replace GMP/ISO/CE.
Donated products: specific conditions (Chapter 1.1.3.4).
Controlled substances: separate import licence required (narcotic drugs, psychotropic substances, precursors per Law 03/2012).
Export: export licence required, eligibility criteria defined (Chapter 2).
Personal effects: separate guideline (FDSIM/FDIEC/GDL/004).

==============================================================
SECTION 2: MEDICAL DEVICES & IVDs
==============================================================
Guideline: DHT/GDL/024 (Guidelines on Submission of Documentation for Registration of Medical Devices)
Developed in reference to EAC harmonisation, AMDF, WHO, IMDRF.
Registration/notification required before marketing.
Classification: risk-based (aligned with IMDRF/EAC framework).
Essential principles of safety, quality and performance must be demonstrated.
Notification/registration fees prescribed.
Reference number assigned upon application receipt.
Queries: must respond in one submission. Two unsatisfactory resubmissions = rejection.
Device classification: 4 classes (A-D). Fees per CBD/TRG/004 Rev_2 (Dec 2024): Class A USD 500, B USD 1,000, C USD 1,500, D USD 2,500.

==============================================================
SECTION 3: COMPLEMENTARY / HERBAL
==============================================================
Medicated cosmetics regulated by Rwanda FDA.
Household chemical substances regulated.
Cosmetics: registration and quality/safety promotion across districts (Feb 2024 campaign).
Medicated cosmetics: separate regulations (CBD/TRG/011) and guidelines. Antiseptics/disinfectants, household pesticides, cleaning chemicals, laboratory chemicals: each has dedicated regulations/guidelines/forms.

==============================================================
SECTION 3B: BIOLOGICALS / VACCINES
==============================================================
Rwanda FDA publishes Guidelines for Registration of Human Biological Products and of Biosimilar Products, and a Guideline/Regulation for lot release of vaccines and biological products (see GUIDELINE INDEX).
Rwanda FDA hosts the BioNTech mRNA biontainer facility (first batch arrived March 2023); the SAHPRA MoU (April 2024) includes mRNA vaccine regulatory oversight.

==============================================================
SECTION 4: CLINICAL TRIALS
==============================================================
Clinical trial fees (CBD/TRG/004 Rev_2): Phase I USD 4,000 / Phase II USD 4,000 / Phase III USD 3,000; research institution foreign USD 4,000 / domestic USD 2,000; amendment of an approved trial USD 500.
The Reliance Guideline (ODG/RAHC/GDL/001 Rev_3) covers reliance on GCP inspections and clinical-trial oversight (see SECTION 1.2).

==============================================================
SECTION 5: POST-MARKET / PHARMACOVIGILANCE
==============================================================
Pharmacovigilance system in place.
Adverse event reporting required.
Post-market surveillance conducted.
Pharmacovigilance regulation (CBD/TRG/016) with reliance provisions (Art 28). Promotion/advertisement regulations (CBD/TRG/017).
VARIATIONS:
Guideline: Draft Guidelines for Variation of Registered Pharmaceutical Products.
Categories: Annual Notification (AN), Immediate Notification (IN), Minor Variation, Major Variation.
AN/IN: minimal or no adverse effects -- notify after implementation.
Minor/major: require prior acceptance before implementation.
Rwanda FDA consultation recommended before submission for classification guidance.

==============================================================
SECTION 6: KEY TIMELINES
==============================================================
Screening: 30 calendar days.
[FIELD] Full assessment: 6-12 months typical.
[FIELD] Abbreviated procedure: potentially 3-6 months.
[FIELD] Rwanda FDA recognised for efficient, responsive regulatory process within EAC.
Export authorisation processing: 3 working days.
Rwanda is home of the African Medicines Agency (AMA) headquarters (Kigali). AMA inaugurated Director General Dr. Delese Mimi Darko (Ghana) in June 2025.
EUR 2M EU Twinning project launched May 2023 to improve medicinal product regulation.
MoU with Ghana FDA (Nov 2022) for mutual cooperation. MoU with SAHPRA (April 2024) for joint product reviews, inspections, and mRNA vaccine regulatory oversight.

==============================================================
GUIDELINE INDEX
==============================================================
ADDITIONAL PUBLISHED REGULATIONS AND GUIDELINES:
- Regulations Governing Fees (CBD/TRG/004 Rev_2, updated December 2024): payable in RWF or USD, non-refundable
- Guidelines for pharmaceutical mark-ups across supply/distribution chain (Sep 2025)
- Guidelines for Appeals against Rwanda FDA decisions (30 working days to appeal; Board of Directors final decision)
- Guidelines/Regulation for lot release of vaccines and biological products
- Regulations governing analysis of products regulated by Rwanda FDA
- Variation of registered pharmaceutical products guideline (notification/minor/major)
- Pharmacovigilance regulation (CBD/TRG/016) with reliance provisions (Art 28)
- Promotion/advertisement regulations (CBD/TRG/017)
- Client Service Charter (processing standards)
[OFFICIAL -- Rwanda FDA Guidelines on Abbreviated Procedures for Registration of Pharmaceutical Products, DD/HMDR/GDL/004 Version 3, effective 15 August 2024] Abbreviated (abridged) registration procedures domesticated from the EAC joint-assessment abridged procedures, used to accelerate national registration of products already approved by recognised reference regulatory authorities, trusted institutions and regulatory harmonisation initiatives. Version 3 REMOVED the mandatory requirement for a GMP application before issuance of Marketing Authorization where the recognition procedure is applied.
[OFFICIAL] Rwanda FDA's current guideline and regulation suite also includes: the Regulation Governing Registration of Medical Devices including IVDs; Guidelines for Registration of Medical Devices and for submission of IVDD documentation; Guidelines for Registration of Human Biological Products and of Biosimilar Products; Guidelines for Renewal of Registered Human Pharmaceutical Products (Version 2); the Guideline for Registration of Innovative Medical Products and of medical products for unmet medical needs; Guidelines for the Cancellation or Suspension of a registered medical product; Guidance on good practices for desk assessment of GMP/GLP compliance; the Regulations Governing tariffs, fees and charges on services rendered (No. ODG/IMPOTR/G/001 Rev 3); and a full suite of veterinary medicine, biological and device guidelines.
[OFFICIAL] Further Rwanda FDA guideline and regulation document references: Guidelines for Renewal of Pharmaceutical Products Marketing Authorization -- DD/HMDR/GDL/009 Version 2 (August 2024); Guidelines on Submission of Documentation for Registration of Medical Devices -- DHT/GDL/024 Rev 0 (May 2020), which adopts the GHTF Summary Technical Documentation (STED) format and is issued under technical regulation CBD/TRG/012; the Regulation Governing Registration of Medical Devices including IVDs; and the Regulation Governing tariffs, fees and charges on services rendered (No. ODG/IMPOTR/G/001 Rev 3).

==============================================================
SHAAMI TANZANIA REGULATORY KNOWLEDGE BASE -- TMDA
Regulator: Tanzania Medicines and Medical Devices Authority (TMDA)
Legal basis: Tanzania Medicines and Medical Devices Act Cap 219 (formerly TFDCA, amended by Finance Act 2019)
Address: P.O. Box 1253, Dodoma / P.O. Box 77150, Dar es Salaam, Tanzania
Website: www.tmda.go.tz | Portal: RIMS / IMIS2 (imis2.tmda.go.tz)
NRA maturity: WHO Maturity Level 3 (one of first 5 African countries); ISO 9001:2015 certified
Sources: TMDA Guidelines, Fees and Charges Regulations 2022, GN No. 686, secondary sources
Last updated: April 2026
==============================================================

REGULATOR AND PORTALS
- RIMS (imis2.tmda.go.tz) for: online medicine registration, import/export permits, premises registration, GMP applications, clinical trial applications, medical device registration
- Executive Agency under Ministry of Health
- Three laboratories: Dar es Salaam, Mwanza, Dodoma
- Registration valid: 5 years, renewable (subject to annual retention fees)
- Ministerial Advisory Board (MAB) oversight
INSTITUTIONAL STRUCTURE (from tmda.go.tz, verified April 2026):
ISO 9001:2015 certified. Executive Agency under Ministry of Health.
HQ: PSSSF Building, Makole, P.O. Box 1253, Dodoma. Sub-HQ: Mabibo External, P.O. Box 77150, Dar es Salaam.
8 Zone Offices: Central, Eastern Lake, Eastern, Northern, Southern Highlands, Southern, Western Lake, Western.
3 Laboratories: Dar es Salaam, Mwanza, Dodoma.
DIGITAL PLATFORMS:
- IMIS2 portal (imis2.tmda.go.tz): online submission for product registration, premises, GMP, clinical trials, import/export
- SQRT (sqrt.tmda.go.tz): Safety and Quality Reporting Tool for adverse events
- Clinical Trial Registry: imis2.tmda.go.tz/#/public/clinical-trials
- Registered products databases: medicines, medical devices, notified devices, registered premises
- Public GMP Inspection Reports published
- Medical Devices Public Assessment Reports published (from Oct 2024)
HARMONISATION:
Medicines: AMA, AMRH, WHO Collaborative Procedure, EAC Mutual Recognition Procedures (EAC-MRP)
Medical devices: AMDF, WHO, GHWP, IMDRF
AU-3S Programme participant. BREEDIME Project. Gates Global Grand Challenges.

LOCAL REPRESENTATIVE
Local Technical Representative (LTR) required for foreign manufacturers. TMDA publishes list of recognised LTRs on website. LTR facilitates communication and regulatory compliance.

==============================================================
SECTION 1: MEDICINES (HUMAN)
==============================================================
Dossier: CTD format via RIMS portal
Regulations: Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015

1.1 REGISTRATION PATHWAYS
Routine Procedure -- Full CTD assessment for standard applications.
Non-Routine Procedure -- Guidelines published April 2023. For WHO-PQ, SRA-approved, EAC-MRP products. Facilitated/accelerated review.
Emergency Use Authorization -- Guidelines published April 2023, updated September 2022.
WHO Collaborative Registration Procedure (CRP) -- TMDA participates actively.
EAC Mutual Recognition Procedure (EAC-MRP) -- TMDA is a key participant as EAC member.
Similar Biotherapeutics -- Guideline published March 2020.

1.2 RELIANCE / NON-ROUTINE PROCEDURE
[OFFICIAL -- TMDA Guidelines on Regulatory Reliance for Marketing Authorisation of Human Medicinal Products, TMDA/DMC/MRE/G/022 Rev 00, July 2025] TMDA defines four reliance-based evaluation pathways: (1) Abridged review; (2) Verification of sameness; (3) Recognition; and (4) Work-sharing. The applicant selects the pathway and submits documentation accordingly; the guideline also governs reliance applied to variations of registered medicinal products.
[OFFICIAL -- TMDA Guidelines on Processing of Applications for Registration of Medicinal Products through the Non-Routine Procedure, TMDA/DMC/MRE/G/007 Rev 01, April 2023] Made under Regulation 4(1) of the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations 2015, the non-routine procedure provides an expedited review for eligible products (WHO-PQ, SRA or EAC-MRP approved products, and emergency medicines).

1.3 KEY GUIDELINES PUBLISHED
- Guidelines for Registration of Medicinal Products through Non-Routine Procedure (April 2023)
- Guidelines for Emergency Use Authorization of Medicinal Products (April 2023)
- Guidelines on Submission of Documentation for Renewal of Marketing Authorization (January 2021)
- Guidelines for Application to Conduct Clinical Trials (Third Edition, June 2017)
- Guidelines on Variations of Registered Vaccines
- Guidelines for Herbal Medicinal Products
- Guidelines for Biocidals (Antiseptics and Disinfectants) Products (August 2020)
- Guidelines for Veterinary Medicinal Products (March 2020)
- Guidelines for Similar Biotherapeutics Products (March 2020)
- Guidelines for Immunological Veterinary Products (March 2020)
- GMP Inspection Guidelines (Second Edition, January 2025)
- Good Storage and Distribution Practice Guidelines (May 2024)

1.4 FEES -- MEDICINES
[OFFICIAL -- Tanzania Medicines and Medical Devices (Fees and Charges) Regulation, 2022]
Fees in USD for foreign applicants. Payment via GEPG system with Control Number on Proforma Invoice.
Bank accounts: NMB Revenue Bank (USD), NBC USD, CRDB Bank USD.
KEY FEES EXTRACTED:
Foreign GMP inspection: USD 6,000 per plant + inspector travel allowances (cost recovery)
Clinical trial application: USD 3,000
Fast-track clinical trial: double the registration and analysis fee
Clinical trial amendment (major): USD 500
Clinical trial amendment (minor): USD 300
Registration certificate valid: 5 years. GMP certificate valid: 3 years.
Annual retention fees: payable by 31 January each year (failure = import permits suspended).
[OFFICIAL -- GN No. 686, Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2021]
MEDICINES (Imported): New/renewal non-biologicals USD 2,000 | Biologicals USD 3,000 | Retention USD 300 | Variation major USD 1,000 | Variation minor USD 300 | Fast track: DOUBLE the respective fee.
MEDICINES (Domestic): New/renewal TZS 1,000,000 | Variation major TZS 200,000 | Minor TZS 100,000.
Innovator pricing application: USD 200.
MEDICAL DEVICES (Imported): Class A notification USD 100 | Class A registrable USD 500 | Class B USD 2,500 | Class C USD 2,500 | Class D USD 2,500 | Spare parts/accessories USD 500 | Variation major USD 300 | Minor USD 150 | Retention registered USD 200 | Notified USD 50.
MEDICAL DEVICES (Domestic): Class A notification TZS 50,000 | Class A registrable TZS 100,000 | Class B TZS 200,000 | Class C TZS 500,000 | Class D TZS 500,000.
[FIELD] TMDA fees are generally affordable compared to SAHPRA and NAFDAC.
Payment procedures for overseas customers: guidance published April 2024. All overseas payments must go through GEPG.

1.5 GMP REQUIREMENTS
GMP inspection mandatory before product registration.
GMP Inspection Guidelines Second Edition published January 2025.
TMDA conducts foreign manufacturer inspections.
List of inspections conducted published on website.
Public GMP Inspection Reports published (transparency initiative).
Good Storage and Distribution Practice (GSDP) regulations and guidelines in force.
GMP Technical Committee provides oversight.
Renewal of GMP compliance for foreign manufacturers: annual submission required.
GMP INSPECTION FEES (per block, foreign): East Africa USD 4,000 | SADC USD 4,500 | Rest of Africa USD 5,000 | Asia USD 6,000 | Europe USD 6,500 | Americas USD 7,500 | Australia/NZ USD 7,500. Additional 25% per extra production line/block.

==============================================================
SECTION 2: MEDICAL DEVICES & IVDs
==============================================================
Regulation: under Tanzania Medicines and Medical Devices Act Cap 219
TMDA has a dedicated Medical Devices and Diagnostics directorate.
Registration required for all medical devices and IVDs before marketing.
Classification: risk-based (aligned with IMDRF/WHO framework).
Online registration via RIMS portal.
Registered devices database publicly searchable. Notified devices database also available.
Medical Devices Public Assessment Reports published.
Establishment licensing: premises registration required for manufacturers, wholesalers, distributors.
Quality audit conducted for medical device establishments.
Vigilance and post-marketing surveillance for devices.
Fees: per Fees and Charges Regulation 2022 (device-specific schedule published on TMDA website).
DIAGNOSTICS / IVDs (Imported): Class A notification USD 100 | Class A registrable USD 300 | Class B USD 1,000 | Class C USD 1,500 | Class D USD 2,000 | Variation major USD 500 | Minor USD 200 | Retention registered USD 200 | Notified USD 50.
ANTISEPTICS/DISINFECTANTS (Imported): New/renewal USD 300 | Variation USD 100 | Retention USD 80.
Fees payable in TZS or USD equivalent. Non-refundable. Late payment: 15% penalty. GEPG payment system required.
Guidelines for Clinical Performance Studies for IVDs published.

==============================================================
SECTION 3: COMPLEMENTARY / HERBAL
==============================================================
Guidelines for herbal medicinal products published.
Biocidals (antiseptics/disinfectants) guideline published August 2020.
Medical gases regulation in place.
[FIELD] Herbal/complementary medicines regulated by Medicines Control Inspection and Enforcement section. Separate guideline published.

==============================================================
SECTION 3B: BIOLOGICALS / VACCINES
==============================================================
Biologicals are registered under TMDA's marketing-authorisation framework; imported biologicals registration fee USD 3,000 (GN No. 686).
TMDA publishes Guidelines for Similar Biotherapeutics Products (March 2020), Guidelines on Registration of Vaccines, and Guidelines for Registration of Biosimilar Products and of Biotherapeutic Products.
Vaccine post-approval changes follow the Guidelines on Variations of Registered Vaccines; a Surveillance of Adverse Events Following Immunization (AEFI) guideline (2nd edition, December 2022) covers vaccine safety monitoring.

==============================================================
SECTION 4: CLINICAL TRIALS
==============================================================
TMDA Clinical Trials Control and Pharmacovigilance (CTPV) section under Directorate of Human and Veterinary Medicines.
Clinical Trials Technical Committee (CTTC) provides independent technical advice.
Guidelines for Application to Conduct Clinical Trials (Third Edition, June 2017).
Online submission via RIMS portal.
Clinical Trial Registry System publicly accessible.
Pharmacovigilance Regulations in force -- serious adverse events reporting mandatory.
GCP inspection of investigator sites conducted.
Harmonisation initiatives for clinical trials across EAC.
Clinical trial application fee: USD 3,000 (per Fees and Charges Regulation 2022); amendment major USD 500, minor USD 300; fast track DOUBLE. Payment via GEPG.

==============================================================
SECTION 5: POST-MARKET / PHARMACOVIGILANCE
==============================================================
Pharmacovigilance regulations and guidelines in force.
Drug Safety Bulletin published regularly.
Safety and Quality Reporting Tool (SQRT) available online.
Post-marketing surveillance active.
Recall of products and rapid alert system in place.
Disposal of unfit products procedures published.
Vaccines: Surveillance of Adverse Events Following Immunization guideline (2nd ed, Dec 2022).

==============================================================
GUIDELINE INDEX
==============================================================
[OFFICIAL] TMDA's current marketing-authorisation guideline suite also includes: Guidelines on Submission of Documentation for Renewal of Marketing Authorization of human and veterinary medicinal products; the TMDA Variations Guidelines (March 2020) with a dedicated Vaccine Variation guideline; TMDA Guidelines on Registration of Vaccines; Guidelines for Registration of Biosimilar Products and of Biotherapeutic Products; Guidelines on Submission of Documentation for Marketing Authorization of Herbal products; Guidelines for Clinical Performance Studies for IVDs; and a consolidated Compendium of Guidelines for Marketing Authorization of Medicinal Products. Registration fees remain governed by Government Notice GN No. 686.
[OFFICIAL] Further TMDA guideline document references: Submission of Documentation for Renewal of Marketing Authorization of Human and Veterinary Medicinal Products -- TMDA/DMC/MRE/G/003 Rev 2 (January 2021, made under section 17 of the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations 2015); Guidelines on Variations on Registered Medicinal Products -- TMDA/DMC/MRE/G/002 Rev 03 (March 2020).
ADDITIONAL PUBLISHED GUIDELINES (from tmda.go.tz/publications):
- Biotherapeutics registration guideline (TMDA/DMC)
- Renewal of registration guideline (TMDA/DMC/MRE/G/003)
- SmPC format/content guideline (TFDA/DMC/HVR/G/001)
- Medical devices registration guideline (2020)
- Medical devices quality audit guideline (TMDA/DMD/MDL/G/001)
- Medical devices vigilance guideline (TMDA/DMD/MDV/GD/001)
- Controlled drugs dealing guideline
- GCP/GCLP inspection guideline
- National Pharmacovigilance Roadmap
- Orphan Medicines pathway available
- Local Technical Representatives list published
- Authorized ports of entry list published
NEW REGULATIONS (2025):
- Scheduling of Medicines Regulation (Dec 2025): categories include controlled, prescription-only, pharmacy-only, behind-the-counter, OTC, general sales, ADDO prescription. ADDO = Accredited Drug Dispensing Outlets (unique to Tanzania).
- GMP Guidelines for Inspection of Human Medicinal Products Manufacturing Facilities (2nd Edition, Jan 2025)
- Goods Storage and Distribution Practices (GSDP) Regulations (2021)
FEES: Tanzania Medicines and Medical Devices (Fees and Charges) Regulation, 2022 (current). Payment via GEPG (Government Electronic Payment Gateway). Control Number required for each payment. Overseas payment: GEPG TMDA Collection Account (USD) at NMB or NBC or CRDB. Annual retention fees due before 31 January each year. Import permits blocked if retention fees unpaid.

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SHAAMI SENEGAL REGULATORY KNOWLEDGE BASE -- ARP
Regulator: Agence Senegalaise de Reglementation Pharmaceutique (ARP)
Legal basis: Loi n.2023-06 du 13 juin 2023; Decret n.2022-824 du 07 avril 2022; UEMOA Reglement n.04/2020/CM/UEMOA
Address: Dakar, Senegal
Website / portal: www.arp.sn ; digital homologation platform services.arp.sn
NRA maturity: WHO Maturity Level 3 (ML3, 2024) -- the first francophone African NRA to reach ML3
Sources: ARP guideline suite (2023-2025); UEMOA regulations; scanned ARP guideline PDFs processed by OCR
Last updated: 17 May 2026
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REGULATOR AND PORTALS
ARP is a UEMOA and ECOWAS (CEDEAO) member-state regulator and reached WHO Maturity Level 3 (ML3) -- the first francophone African NRA to do so. The digital homologation platform is services.arp.sn.
LEGAL FRAMEWORK:
[OFFICIAL -- Loi n.2023-06 du 13 juin 2023 relative aux medicaments, aux autres produits de sante et a la pharmacie] The primary pharmaceutical law. Article 134 allows public-health derogations -- special authorisations granted exceptionally to certain categories of medicines and other health products.
[OFFICIAL -- Decret n.2022-824 du 07 avril 2022] Creates the ARP and sets its organisation and functioning rules; ARP holds the market-surveillance / market-control function and clinical-trial oversight.
[OFFICIAL -- Decret n.2025-1833 du 18 novembre 2025] Fixes the fees (redevances) arising from regulation of the pharmaceutical sector and the modalities for their collection; published in the Journal Officiel of the Republic of Senegal.
[OFFICIAL -- Reglement n.04/2020/CM/UEMOA] Governs the procedures for registration (homologation) of human pharmaceutical products across UEMOA member states; Senegal applies the UEMOA-harmonised CTD dossier format.

LOCAL REPRESENTATIVE
[FIELD] Senegal applies the UEMOA / ECOWAS harmonised CTD dossier format; a local pharmaceutical establishment licensed by ARP is required for foreign manufacturers; all submissions are in French; stability climatic Zone IVb; ARP achieved WHO Maturity Level 3 in 2024.

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SECTION 1: MEDICINES
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1.1 REGISTRATION (HOMOLOGATION / AMM)
[OFFICIAL -- Reglement n.04/2020/CM/UEMOA; Lignes directrices CTD, ECOWAS/CEDEAO, June 2018] Standard registration uses full CTD-format dossier evaluation. The AMM is the legal document issued for the marketing or free distribution of a product after evaluation of its safety, efficacy and quality.
[OFFICIAL -- ARP Ligne directrice decrivant les autres modalites de delivrance d'AMM (fast track, confiance, collaboration), Juillet 2023] Besides full evaluation, ARP offers three alternative AMM pathways, each with a decision communicated to the applicant within 60 days:
- FAST TRACK: for WHO-prequalified products; public-health products (antiretrovirals, antimalarials, anti-tuberculosis medicines, mother-and-child health products, neglected-tropical-disease medicines, and products subject to a PNA tender); and products registered by national regulators at WHO Maturity Level 3 or above. The application requires a fast-track request letter, the prequalification / assessment report, a complete CTD dossier where necessary, evidence of GMP compliance, a batch-release certificate for vaccines, and the current Quality Information Summary (QIS).
- ABBREVIATED / RELIANCE (confiance) PROCEDURE: for a product approved by at least one NM3+ regulator at the time of submission; reserved for serious life-threatening conditions and unmet local medical needs (currently cancer and the infectious diseases dengue, tuberculosis, hepatitis and malaria). The reliance request is made together with the application letter, justified by local disease burden and unmet need.
- COLLABORATION PROCEDURE: for products approved through UEMOA or ECOWAS joint evaluation, the WHO collaborative registration procedure, or by an NRA that has signed a collaboration agreement with ARP. The application must be lodged with ARP within 3 years of approval by the chosen primary reference body, accompanied by the unredacted assessment report; otherwise it is rejected at pre-screening.
[OFFICIAL -- ARP Note circulaire MSAS/ARP, plateforme digitale de l'homologation] In line with Reglement n.04/2020/CM/UEMOA, ARP has digitalised its homologation platform (services.arp.sn) for managing AMM registrations, variations and renewals.
[OFFICIAL -- ARP Ligne directrice relative au refus, suspension, retrait d'AMM au Senegal, 17 July 2023] Under Articles 20-22 of Reglement n.04/2020/CM/UEMOA an AMM may be refused, suspended or withdrawn after a reasoned opinion. A suspension is a temporary, usually urgent measure not exceeding 1 year and may lead to withdrawal. An AMM may be cancelled if the product is not placed on the market within 3 years of its grant, or on safety/quality grounds (harmful product, lacking therapeutic effect, non-conforming composition).

1.2 TEMPORARY-USE AND EMERGENCY AUTHORISATIONS (ATU / RTU / EUA)
[OFFICIAL -- ARP Ligne directrice sur les conditions de delivrance des ATU et RTU, Juin 2023] An Autorisation Temporaire d'Utilisation (ATU) may be "nominative" (one named patient, under a prescribing physician's responsibility, with a 30-day assessment procedure) or "de cohorte" (a patient group, granted shortly before AMM once trial data are robust). An ATU is granted for 1 year, renewable. A Recommandation Temporaire d'Utilisation (RTU) authorises a prescription not conforming to the AMM (off-label use) where no product with the same active ingredient holds an AMM or ATU in that indication; an RTU is established for a maximum of 3 years, renewable, and promotion of an RTU indication is prohibited.
[OFFICIAL -- ARP Ligne directrice pour l'autorisation d'utilisation d'urgence des produits medicaux, Juillet 2023] Under Article 134 of Loi n.2023-06, ARP may grant an Emergency Use Authorisation (EUA) for an unregistered medical product, or for unapproved use of a registered one (allopathic medicines, biologicals including vaccines, medical devices), during a declared public-health emergency where no adequate, approved and available alternative exists.

1.3 GMP
[OFFICIAL -- BPF UEMOA] Good manufacturing practice follows the UEMOA good manufacturing practice guide.

1.4 IMPORT / EXPORT
[OFFICIAL -- ARP Ligne directrice des demandes d'importation et d'exportation de medicaments et autres produits de sante, Decembre 2023] Every import or export of a medicine requires an ARP authorisation. All imported products must hold an AMM, except those granted an exceptional authorisation. Imports pass through the ORBUS customs dematerialisation platform via official entry points (Diass airport, the port of Dakar, and the land borders with Mauritania, Mali, Guinea-Bissau, Guinea Conakry and the Gambia). Products with less than 6 months' shelf life may not be imported. An import authorisation is valid 3 months, non-transferable and single-use (maximum 6 months for controlled substances). Import applications must be lodged at ARP headquarters at least 10 days before the products arrive (reducible to 3 days in emergencies) and are processed within a maximum of 10 days from filing (3 days in emergencies), exceptionally extendable to 1 month. An export authorisation is valid 3 months; export applications are lodged at least 15 days before shipment and processed within a maximum of 15 days. Exceptional import of unregistered products requires a GMP certificate from the country of manufacture and that country's AMM or a Certificate of Pharmaceutical Product (CPP), and is granted only where no registered therapeutic equivalent is available in Senegal. An appeal against an ARP decision may be lodged with the Director-General within 14 days, and thereafter with the Minister of Health.

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SECTION 2: MEDICAL DEVICES & IVDs
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The manufacture and wholesale distribution of medical devices and of in-vitro diagnostic devices are subject to ARP oversight (see SECTION 3 -- listed among the establishments covered by the pharmaceutical-regulation fee decree). The detailed medical-device / IVD registration framework was not extracted in this pass (see gap note below).

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SECTION 3: COMPLEMENTARY / HERBAL
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[OFFICIAL -- Decret n.2025-1833 du 18 novembre 2025 (list of regulated establishments); ARP rapport sur les complements alimentaires] Cosmetic products, nutritional supplements (complements alimentaires) and phytomedicines are regulated; the manufacture and wholesale distribution of medical devices and of in-vitro diagnostic devices are subject to ARP oversight, as listed among the establishments covered by the pharmaceutical-regulation fee decree.

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SECTION 3B: BIOLOGICALS / VACCINES
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[OFFICIAL -- ARP Guide d'evaluation technique des medicaments biosimilaires (DIHS-HOM SD 005), 17 July 2023; ARP Ligne directrice sur l'evaluation des produits biologiques, 2023] The administrative evaluation of a biosimilar is identical to that of a standard medicine; it adds a comparability exercise against the reference biological medicine across CTD Module 3 (quality), Module 4 (non-clinical) and Module 5 (clinical), an immunogenicity assessment and a pharmacovigilance plan. ARP aligns with the EMA, WHO and ICH biosimilar guidelines. A dedicated guideline governs the technical evaluation of biological products.

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SECTION 4: CLINICAL TRIALS
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[OFFICIAL -- ARP Ligne directrice relative a la conduite d'essais cliniques au Senegal, Septembre 2023; Loi n.2009-17 portant Code d'Ethique pour la Recherche en Sante; ARP Decision 005 portant adoption des lignes directrices relatives aux essais cliniques] Clinical trials conducted in Senegal are overseen by ARP. The clinical-trial application follows a CTD-style modular dossier (administrative, non-clinical/clinical/quality summaries, investigational-product quality, clinical study reports, medical devices), may be preceded by a pre-submission meeting, and an accelerated procedure handles authorisation requests within a maximum of 30 working days. A separate guideline covers the conduct of clinical trials in emergency situations.

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SECTION 5: POST-MARKET / PHARMACOVIGILANCE
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[OFFICIAL -- ARP Guide de bonnes pratiques de pharmacovigilance, 2023] Pharmacovigilance follows a dedicated ARP good-practice guide.
[OFFICIAL -- ARP Ligne directrice surveillance du marche, 2023; ARP Ligne directrice pour la surveillance post-marketing de la qualite des medicaments selon une approche basee sur les risques; ARP Decision 004 instituant le programme de surveillance de la qualite des medicaments; ARP Lignes directrices sur les plaintes et reclamations] Market surveillance and risk-based post-marketing quality surveillance are each governed by a dedicated guideline; ARP also publishes guidelines on complaints and recalls.

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SECTION 6: KEY TIMELINES
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Alternative AMM pathways (fast track / reliance / collaboration): decision communicated within 60 days (see SECTION 1.1). Clinical-trial authorisation, accelerated procedure: maximum 30 working days (see SECTION 4). Import authorisation: processed within a maximum of 10 days from filing, exceptionally extendable to 1 month; export authorisation: maximum 15 days (see SECTION 1.4). Nominative ATU assessment procedure: 30 days (see SECTION 1.2).

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GUIDELINE INDEX
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Loi n.2023-06 du 13 juin 2023 -- medicines, other health products and pharmacy
Decret n.2022-824 du 07 avril 2022 -- creation of the ARP
Decret n.2025-1833 du 18 novembre 2025 -- fees (redevances) of pharmaceutical-sector regulation
Reglement n.04/2020/CM/UEMOA; Lignes directrices CTD ECOWAS/CEDEAO (June 2018)
ARP Ligne directrice -- autres modalites de delivrance d'AMM (fast track, confiance, collaboration), Juillet 2023
ARP Note circulaire MSAS/ARP -- plateforme digitale de l'homologation
ARP Ligne directrice -- refus, suspension, retrait d'AMM (17 July 2023)
ARP Ligne directrice -- ATU et RTU (Juin 2023)
ARP Ligne directrice -- autorisation d'utilisation d'urgence des produits medicaux (Juillet 2023)
ARP Ligne directrice -- demandes d'importation et d'exportation (Decembre 2023)
ARP Guide d'evaluation technique des medicaments biosimilaires (DIHS-HOM SD 005, 17 July 2023); Ligne directrice sur l'evaluation des produits biologiques (2023)
ARP Ligne directrice -- conduite d'essais cliniques au Senegal (Septembre 2023); Decision 005
ARP Guide de bonnes pratiques de pharmacovigilance (2023)
ARP Ligne directrice surveillance du marche (2023); surveillance post-marketing basee sur les risques; Decision 004; Lignes directrices plaintes et reclamations
BPF UEMOA -- good manufacturing practice guide

[GAP] Specific ARP fee amounts were not extracted -- Decret n.2025-1833 du 18 novembre 2025 sets the fee schedule, but the published fee grid is a scanned image not amenable to text extraction; verify the fee amounts and the detailed medical-device / IVD registration framework directly with ARP.

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SHAAMI COTE D'IVOIRE REGULATORY KNOWLEDGE BASE -- AIRP
Regulator: Autorite Ivoirienne de Regulation Pharmaceutique (AIRP)
Legal basis: Loi n.2017-541 du 3 aout 2017; Decret n.2018-926; UEMOA Reglement n.04/2020/CM/UEMOA
Address: Cocody-Riviera Bonoumin, 08 BP 3535 Abidjan 08
Website / portal: www.airp.ci
NRA maturity: AIRP is an independent administrative authority; Cote d'Ivoire is a UEMOA and ECOWAS member applying UEMOA-harmonised pharmaceutical regulation
Sources: AIRP guideline suite; UEMOA regulations; scanned guideline PDFs processed by OCR
Last updated: 17 May 2026
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REGULATOR AND PORTALS
AIRP is an independent administrative authority with legal personality and financial autonomy. Cote d'Ivoire is a UEMOA and ECOWAS member; AIRP applies UEMOA-harmonised pharmaceutical regulation.
LEGAL FRAMEWORK:
[OFFICIAL -- Loi n.2017-541 du 3 aout 2017 relative a la regulation du secteur pharmaceutique] Creates the AIRP as the national pharmaceutical regulator, an independent administrative authority. AIRP grants marketing authorisations, establishment licences, GMP certificates, import/export and clinical-trial authorisations, and conducts pharmaceutical inspection and market surveillance. No pharmaceutical product may be placed on the Ivorian market, free or for payment, without a Marketing Authorisation (AMM) -- Art. 18. In a public-health necessity an accelerated AMM procedure may be used exceptionally -- Art. 19. Clinical trials require AIRP authorisation after the conforming opinion of the national ethics committee -- Art. 27. Penal sanctions: a false or misleading AMM declaration carries 2 to 6 years imprisonment and a 500,000 to 5,000,000 FCFA fine (10,000,000 to 100,000,000 FCFA for a legal person); falsified-medicine offences carry 5 to 10 years.
[OFFICIAL -- Loi n.2015-533 du 20 juillet 2015 relative a l'exercice de la pharmacie; Loi n.2015-534 du 20 juillet 2015 portant Code de deontologie pharmaceutique] Govern the practice of pharmacy and pharmaceutical ethics.
[OFFICIAL -- Decret n.2018-926 du 12 decembre 2018] Sets the organisation and functioning of the AIRP.
[OFFICIAL -- Reglement n.04/2020/CM/UEMOA du 28 septembre 2020] Defines UEMOA procedures for the homologation (registration) of human pharmaceutical products; Reglement n.02/2005 and Reglement n.01/2022/CM/UEMOA harmonise pharmaceutical regulation, and Directive n.06/2020/CM/UEMOA sets the status of UEMOA national pharmaceutical regulators.

LOCAL REPRESENTATIVE
[FIELD] A local establishment licensed by AIRP (a pharmaceutical representation or distribution agency) is required for foreign manufacturers; all submissions are in French; Cote d'Ivoire applies the UEMOA-harmonised CTD dossier format; stability climatic Zone IVb.

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SECTION 1: MEDICINES
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1.1 REGISTRATION (HOMOLOGATION / AMM)
[OFFICIAL -- Loi 2017-541, Art.18] Homologation covers registration, renewal and variations; the AMM is the official document authorising marketing or free distribution of a pharmaceutical product.
[OFFICIAL -- AIRP Note circulaire n.0976/AIRP, March 2026] AIRP receives registration dossiers in periodic ordinary sessions. Applicants are selected through a call for expression of interest that prioritises priority molecules, therapeutic innovations and treatments for chronic or orphan diseases; an annual reception plan governs scheduling (the 2026 ordinary registration session ran 7-17 April 2026). Only selected applicants are invited to lodge dossiers; reception is by appointment, 08h30-15h30.
[OFFICIAL -- AIRP Note d'information, 22 May 2026] Registration, variation and renewal notifications ("ajourne", "accepte sous reserve", "accepte", "accepte avec recommandations") are transmitted by email; applicants' responses to notifications must be returned exclusively by email to notifications@airp.ci.

1.2 RELIANCE / RECOGNITION
[OFFICIAL -- Decision n.0014/AIRP/DG du 1 septembre 2025, modifying Decision n.0004/AIRP/DG du 13 fevrier 2025] AIRP may rely on or recognise certificates, reports or decisions issued by: national regulators that have reached WHO Maturity Level 3 or above; WHO Listed Authorities (WLA); ICH-member regulators; international bodies of which Cote d'Ivoire is a member (the WHO, including its collaborative registration procedure; the African Medicines Agency, AMA; the West African Health Organisation, WAHO/OOAS; UEMOA; and AVAREF); and members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Reliance and recognition apply to homologation, inspection of manufacturing and distribution establishments, clinical trials, laboratory testing, vigilance and batch release. AIRP remains fully independent and responsible for the decisions it adopts. The framework is based on WHO Good Regulatory Practices, Annex 11, WHO Technical Report Series No.1033 (2021).

1.3 FEES (Decision n.007/AIRP/CR du 28 avril 2023 fixing AIRP service tariffs)
[OFFICIAL -- Decision n.007/AIRP/CR du 28 avril 2023] An Autorisation de Commercialisation (AC) for "other pharmaceutical products" is valid 5 years (3 years for traditional-medicine products). The base registration fee is charged for each dosage, each pharmaceutical form and each presentation. Major variation = 100% of the base fee; minor variation = 10%; renewal = 50%. The base fee is reduced by 50% for products manufactured locally or in another UEMOA member state. Late-renewal penalties: +20% per month for the first 6 months after expiry, +30% per month from month 7 to month 12, and +50% per month beyond 12 months.
[OFFICIAL -- Decision n.007/AIRP/CR, Annexe 1] Herbal / traditional-pharmacopoeia medicines manufactured in Cote d'Ivoire (WHO class 1): registration 100,000 FCFA, major variation 100,000, minor variation 10,000, renewal 50,000. Medical-device declaration for classes A (I) and B (IIa): 10,000 FCFA. Laboratory-reagent declaration: 40,000 FCFA.
[OFFICIAL -- Decision n.007/AIRP/CR, Annexe 2] Establishment licence fees (FCFA): private pharmacy (officine) creation licence 100,000; opening of a pharmaceutical sales depot 150,000; pharmaceutical-industry exploitation licence 2,500,000 (renewal 2,500,000, 5-year validity); medical-biology analysis laboratory creation 1,000,000; clinical-trial service provider (CRO) registration 1,000,000.
[OFFICIAL -- Decision n.007/AIRP/CR, Annexe 3] Other services (FCFA): Prior Import Authorisation (API) per product type for 10 lines, 3-month validity; Special Import Authorisation for near-expiry products 40,000 (3-month validity); Special Import Authorisation for non-homologated products 20,000; Removal Authorisation (Autorisation d'Enlevement) per dossier 10,000; quarterly export authorisation for biological samples 100,000; advertising/promotion/information authorisation 500,000 per laboratory. GMP (BPF) certificate issue/renewal: local Ivorian industries 500,000; foreign industries in Africa 3,000,000; in Europe 5,000,000; elsewhere 10,000,000 (5-year validity). Good Distribution Practice (BPD) certificate for wholesalers, importers and depositaries 300,000 (1-year validity). Duplicate of any document 5,000 per page.
[OFFICIAL -- AIRP Modalites d'obtention d'une licence d'exploitation d'une officine privee de pharmacie, 17 April 2023] A private pharmacy operating licence requires an AIRP conformity visit and a dossier (current-year ONPCI registration attestation, creation-licence copy, trade register, fiscal declaration of existence, AIRP conformity-visit report, etc.) accompanied by a 250,000 FCFA cheque for dossier fees, submitted in 2 copies.

1.4 GMP & ESTABLISHMENTS
[OFFICIAL -- Loi 2017-541; Decision n.08/2010/CM/UEMOA] Pharmaceutical products must be manufactured according to Good Manufacturing Practice (BPF -- the UEMOA GMP guide) and distributed according to Good Distribution Practice (BPD). Opening and operating any pharmaceutical establishment (manufacturing, import/export, wholesale, representation, distribution, dispensing, quality-control laboratory, cosmetics manufacturing) is subject to an authorisation issued by AIRP.
[OFFICIAL -- AIRP Note d'information, 11 December 2025] AIRP has replaced the former "modalites" for granting establishment licences with consolidated lignes directrices -- one document per establishment category -- setting out the documents required for creation, renewal or modification of an agrement, the legal operating requirements, and the process and timelines for obtaining the agrement; published on www.airp.ci.

1.5 IMPORT / EXPORT
[OFFICIAL -- Decision n.0005/AIRP/DG, February 2025, conditions d'importation et d'exportation des produits pharmaceutiques] Import or export of any pharmaceutical product requires a prior authorisation (Autorisation Prealable a l'Importation / a l'Exportation, API/APE) issued by AIRP, granted only to AIRP-licensed establishments. An import or export authorisation is single-use, nominal and non-transferable. A special and provisional import authorisation may be granted exceptionally only in a public-health emergency. Entry and exit points are set by AIRP jointly with customs; processing times and authorisation validity are defined in annexed guidelines.
[OFFICIAL -- AIRP-FOR-7.1.1-05.3-02-001 v01, 31/01/2024, Liste de controle - demande d'autorisation d'importation] Import dossier checklist: demand letter to the AIRP Director-General specifying the entry route (2 copies); final or proforma invoice (2 copies); quality documents (medicines: batch-release certificate; medical devices: certificate of conformity; vaccines: batch-release certificate of the biological product); the importer's agrement; and the fee payment receipt.

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SECTION 2: MEDICAL DEVICES & IVDs
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[OFFICIAL -- Decision n.03/2022/CM/UEMOA du 24 juin 2022] Adopts the UEMOA guidelines harmonising medical-device regulation; marketing and putting-into-service authorisations for medical devices are issued by the national pharmaceutical regulator, and member states were given 24 months to establish the institutional and legal framework. AIRP has issued a decision on the regulation of medical devices; device classes A (I) and B (IIa) are subject to declaration.

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SECTION 3: COMPLEMENTARY / HERBAL
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[OFFICIAL -- Decision n.07/2010/CM/UEMOA (cosmetics); Decision n.06/2010/CM/UEMOA (nutritional supplements); AIRP decret reglementant les produits cosmetiques et les produits d'hygiene corporelle; AIRP decret reglementant les substituts du lait maternel] Cosmetic products, nutritional supplements and breast-milk substitutes are regulated; a separate AIRP decision sets conventional tariffs for diabetes and hypertension medicines.

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SECTION 3B: BIOLOGICALS / VACCINES
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[OFFICIAL -- AIRP Note d'information, 16 January 2025] All medicines, including vaccines, distributed in Cote d'Ivoire require an AMM. Non-homologated vaccines imported for public-health needs must come from a country at WHO GBT Maturity Level 3 or above and be WHO-prequalified; failing that, a liability engagement letter (invoice number and date, supplier name and address, vaccine list, batch numbers) is required.

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SECTION 4: CLINICAL TRIALS
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[OFFICIAL -- Loi 2017-541, Art.27-29; Decret n.2020-407 du 22 avril 2020 portant reglementation des essais cliniques] No clinical trial may be undertaken in Cote d'Ivoire without an AIRP authorisation issued after the conforming opinion of the national ethics committee; trials must be conducted in accordance with good clinical practice. A dedicated AIRP decision governs the authorisation of phase I, II, III and IV clinical trials in alternative (emergency) situations. False or misleading clinical-trial declarations carry 2 to 10 years imprisonment and fines up to 1,000,000,000 FCFA for a legal person.

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SECTION 5: POST-MARKET / PHARMACOVIGILANCE
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[OFFICIAL -- Arrete n.210 de pharmacovigilance; Loi 2017-541, Art.31] AIRP organises and implements vigilance and pharmaceutical market surveillance, collecting and evaluating safety information on pharmaceutical products and combating falsified medicines and the illicit market.

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SECTION 6: KEY TIMELINES
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Registration is processed in periodic AIRP sessions (see SECTION 1.1); import/export authorisation processing times and validity are set in annexed guidelines (see SECTION 1.5). Exact dossier-evaluation timelines were not fully extracted -- see gap note below.

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GUIDELINE INDEX
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Loi n.2017-541 du 3 aout 2017 -- regulation of the pharmaceutical sector
Loi n.2015-533; Loi n.2015-534 -- practice of pharmacy; code of pharmaceutical ethics
Decret n.2018-926 du 12 decembre 2018 -- organisation and functioning of AIRP
Decret n.2020-407 du 22 avril 2020 -- regulation of clinical trials
Reglement n.04/2020/CM/UEMOA; n.02/2005; n.01/2022/CM/UEMOA; Directive n.06/2020/CM/UEMOA -- UEMOA harmonisation
Decision n.007/AIRP/CR du 28 avril 2023 -- AIRP service tariffs (Annexes 1-3)
Decision n.0005/AIRP/DG (February 2025) -- conditions of import and export
Decision n.0014/AIRP/DG du 1 septembre 2025 -- regulatory reliance and recognition
Decision n.03/2022/CM/UEMOA -- harmonisation of medical-device regulation
Decision n.07/2010 (cosmetics); n.06/2010 (nutritional supplements); n.08/2010 (UEMOA GMP guide)
AIRP-FOR-7.1.1-05.3-02-001 v01 (31/01/2024) -- import authorisation checklist
AIRP Modalites d'obtention d'une licence d'exploitation d'une officine privee de pharmacie (17 April 2023)
Arrete n.210 de pharmacovigilance

[GAP] The base registration-fee amount for conventional (non-herbal) medicines, exact dossier-evaluation timelines, and the full medical-device classification and fee grid were not fully extracted -- several AIRP fee-annex tables are scanned and only partially OCR-legible; verify directly with AIRP.

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SHAAMI CAMEROON REGULATORY KNOWLEDGE BASE -- DPML
Regulator: Direction de la Pharmacie, du Medicament et des Laboratoires (DPML), Ministry of Public Health
Legal basis: Decret N98-405/PM du 22 October 1998 (homologation and placing on the market of pharmaceutical products)
Address: Yaounde, Cameroon
Website / portal: Ministry of Public Health / DPML
NRA maturity: pre-ML3 (WHO SBM completed)
Currency: CFA Franc (XAF) -- CEMAC zone. Regional: ECCAS, OCEAC, AMA Treaty ratified (15th ratification)
Sources: DPML guideline suite (2018-2023)
Last updated: April 2026
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REGULATOR AND PORTALS
DPML under Ministry of Public Health. Quality control: LANACOME (National Laboratory). OCEAC harmonisation for Central African pharmaceutical regulation. Bilingual (French/English) but regulatory system primarily French.
[OFFICIAL -- Decret N98-405/PM du 22 October 1998 fixing the modalities of homologation and placing on the market of pharmaceutical products] Homologation is the statutory national approval required before a pharmaceutical product may be placed on the Cameroon market; the Marketing Authorization (AMM) is the official document issued by the competent authority. The regulator is the Direction de la Pharmacie, du Medicament et des Laboratoires (DPML), Ministry of Public Health.

LOCAL REPRESENTATIVE
Mandatory local pharmaceutical representative or distributor. Dossiers primarily in French.
A foreign manufacturer must appoint a representative in Cameroon -- a natural person (with a certified letter of designation) or a corporate representative (an approved promotion agency meeting agrement and good-practice conditions).

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SECTION 1: MEDICINES
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1.1 REGISTRATION
Dossier: CTD format. Registration required before marketing/import. LANACOME conducts quality testing.
[OFFICIAL -- DPML Guide Pratique de Soumission des Dossiers d'Homologation des Produits Pharmaceutiques, March 2018] DOSSIER FORMAT: CTD (Common Technical Document) -- Module 1 (administrative / regional information) plus technical Modules 2-5. Generic products NOT requiring bioequivalence: Modules 2 and 3 only. Generics requiring bioequivalence: Modules 2, 3 and 5 (BE section). Innovator products, biosimilars and vaccines: all five modules. MODULE 1 (administrative) requires: cover letter; table of contents; stamped application to the Minister of Public Health; completed AMM application form; applicant pharmacovigilance commitment letter; certified copy of the manufacturer's valid operating licence; certified valid GMP/BPF certificate for every site in the production chain; certified copy of the valid AMM in the country of manufacture and of origin plus AMMs from other countries where registered; WHO-format Certificate of Free Sale or WHO-type certificate of conformity (for products destined to tropical countries); Summary of Product Characteristics; packaging and leaflet mock-ups; proof of payment; and finished-product samples with batch analysis bulletins. Only originals or certified-conforme copies are accepted -- no uncertified scans or photocopies.
[OFFICIAL] STABILITY DATA (minimum at AMM application): accelerated 40+/-2C / 75+/-5% RH for 6 months; long-term 30+/-2C / 75+/-5% RH for 6 months (climatic Zone IVb).
[OFFICIAL] EVALUATION PROCESS: a complete dossier receives a deposit attestation (incomplete dossiers get a rejection check-list); administrative evaluation then technical evaluation (product quality, pharmacopoeia conformity, interchangeability/bioequivalence) by an expert evaluator, then review by the National Medicines Commission. Decisions are either rejet (rejection -- no appeal possible) or reserves (reservations -- recourse possible within 3 months).

1.2 FEES
[OFFICIAL] HOMOLOGATION FEES (DPML): grant of AMM (octroi) 500,000 FCFA; renewal (renouvellement) 250,000 FCFA; variation 100,000 FCFA. Late-renewal penalties apply (the renewal fee multiplied by the number of expired cycles) where renewal is not lodged at least 3 months before AMM expiry. Cosmetic product Autorisation de Commercialisation: 100,000 FCFA per form per product. Biomedical reagent (IVD/reactif) homologation: 10,000 FCFA.
[GAP] GMP inspection and clinical-trial fee amounts not extracted (the homologation, renewal, variation, cosmetic and reagent fees are recorded under SECTION 1.2 above).

1.3 VARIATIONS
[OFFICIAL -- DPML Guide de Variation d'AMM des Produits Pharmaceutiques, 29 June 2023] A dedicated DPML guideline governs variations (modifications, extensions) to a granted AMM.

1.4 RELIANCE
[GAP] Reliance/abridged criteria not documented.

==============================================================
SECTION 2: MEDICAL DEVICES & IVDs
==============================================================
Limited framework. OCEAC/CEMAC harmonisation applies.
[OFFICIAL -- DPML Guide Pratique de Soumission des Dossiers d'Homologation des Reactifs Biomedicaux] Biomedical reagents for medical-biology laboratories and for public use may be placed on the market only after homologation by the DPML, under Decret 98/405/PM.
[GAP] No established public device registration pathway.

==============================================================
SECTION 3: COMPLEMENTARY / HERBAL
==============================================================
[OFFICIAL -- DPML Guide for Cosmetic Products Autorisation de Commercialisation] Cosmetic products require an Autorisation de Commercialisation; a "Personne Responsable" (pharmacist, doctor, design engineer, chemist, biochemist or microbiologist) guarantees product conformity; 10 retail-model samples are required, together with an ANOR cosmetic conformity certificate.

==============================================================
SECTION 5: POST-MARKET / PHARMACOVIGILANCE
==============================================================
An applicant pharmacovigilance commitment letter is required in Module 1 of the AMM dossier (see SECTION 1.1). Post-market evaluation is overseen by the National Medicines Commission.

==============================================================
SECTION 6: KEY TIMELINES
==============================================================
[FIELD] Registration timeline: 12-24+ months.

==============================================================
GUIDELINE INDEX
==============================================================
Decret N98-405/PM du 22 October 1998 -- homologation and placing on the market of pharmaceutical products
DPML Guide Pratique de Soumission des Dossiers d'Homologation des Produits Pharmaceutiques (March 2018)
DPML Guide de Variation d'AMM des Produits Pharmaceutiques (29 June 2023)
DPML Guide Pratique de Soumission des Dossiers d'Homologation des Reactifs Biomedicaux
DPML Guide for Cosmetic Products Autorisation de Commercialisation

KEY FACTS
- Official languages: French and English (bilingual). Largest CEMAC economy (~28M population).
- AMA Treaty ratification (15th country) brought AMA into force in November 2021 -- historic milestone.
- OCEAC (Organisation de Coordination pour la Lutte contre les Endemies en Afrique Centrale) coordinates regional pharma harmonisation.
- LANACOME conducts quality control testing for all regulated products.
- Sub-Regional Program for Harmonisation of National Pharmaceutical Policies in Central Africa (coordinated by OCEAC in Yaounde).
- Stability: Zone IVb. WHO SBM completed.
- Submissions are in French (Cameroon is bilingual; medicine leaflets must be in both French and English).

==============================================================
SHAAMI ETHIOPIA REGULATORY KNOWLEDGE BASE -- EFDA
Regulator: Ethiopian Food and Drug Authority (EFDA)
Legal basis: Food and Medicine Administration Proclamation No. 1112/2019; Council of Ministers Regulation No. 299/2013; Rate of Service Fees Regulation No. 370/2015
Address: Addis Ababa, Ethiopia
Website / portal: www.efda.gov.et
NRA maturity: EFDA (formerly FMHACA) -- WHO benchmarking ongoing
Sources: EFDA guideline and directive suite (2015-2026); Regulation 370/2015 fee schedule (OCR-processed)
Last updated: 17 May 2026
==============================================================

REGULATOR AND PORTALS
Ethiopian Food and Drug Authority (EFDA), Medicine Evaluation and Marketing Authorization Lead Executive Office. Legal basis: Food and Medicine Administration Proclamation No. 1112/2019 and the Food, Medicine and Healthcare Administration and Control Council of Ministers Regulation No. 299/2013. EFDA replaced the former FMHACA. EFDA also publishes barcoding/master-data, Global Location Number (GLN) and Global Trade Item Number (GTIN) allocation guidelines for pharmaceutical traceability.

LOCAL REPRESENTATIVE
A foreign manufacturer must appoint a local agent in Ethiopia. The medicine registration dossier includes an Agency Agreement appointing that local agent (see SECTION 1). Registration of a foreign-based manufacturer's agent (food, medical product, or medical devices & equipment) costs USD 50 for first registration, replacement, additional agency, or renewal (Regulation 370/2015, Schedule 11). A foreign-based medicine manufacturer may open a branch office in Ethiopia -- USD 100 first time, USD 50 renewal (Schedule 16).

==============================================================
SECTION 1: MEDICINES
==============================================================
1.1 REGISTRATION
[OFFICIAL -- EFDA Guideline for Registration of Medicine, EFDA/GDL/017 version 005, approved 30 October 2023; Guideline for Registration of Medicine (1 March 2024)] Medicines are registered via a Common Technical Document (CTD) dossier: Module 1 (administrative and product information), Module 2 (Dossier Overall Summary), Module 3 (Quality), Module 4 (non-clinical study reports), Module 5 (clinical study reports). The dossier requires a Certificate of Pharmaceutical Product (CPP), a GMP certificate for the manufacturing site, and an Agency Agreement appointing a local agent. Bioequivalence study requirements (BCS-based) are annexed.
[OFFICIAL -- EFDA Medicine Marketing Authorization Directive No. 963/2023] The marketing-authorization framework for medicines is set by Directive No. 963/2023, supported by a guideline describing the role and responsibilities of the Marketing Authorization holder and a guideline for preparation and publication of public assessment reports.
[OFFICIAL -- EFDA Guideline for Registration of Low-risk Medicines] A separate streamlined registration pathway applies to low-risk medicines.
[OFFICIAL -- EFDA Guideline for Non-Routine Registration, EFDA/GDL/024 version 001, approved 30 November 2023] A non-routine registration pathway is available for eligible medical products.
[OFFICIAL -- EFDA Guidelines for Conditional Approval] A conditional-approval pathway is available for eligible medicines.
[OFFICIAL -- EFDA Guideline of Medicinal Gases Registration; EFDA Guideline for Temporary Marketing Authorization of Medicinal Gases] Medicinal gases have dedicated registration and temporary-MA guidelines.

1.2 RELIANCE
[OFFICIAL -- EFDA Guidelines on Reliance for Medicine Marketing Authorization, EFDA/GDL/042 version 003, effective 2 December 2024 (Guidelines on Reliance for Marketing Authorization, 2024)] Two reliance pathways: (1) Verification Review and (2) Abridged Review. Eligibility for MA through reliance depends on prior approval by a reference regulatory authority or trusted institution (an annexed list of reference NRAs). Reliance also covers evaluation of post-approval changes and of renewals.
[OFFICIAL -- EFDA Guideline for WHO Pre-qualified Medicines through the Collaborative Registration Procedure (6 September 2023)] WHO-prequalified medicines may be registered through the WHO Collaborative Registration Procedure (CRP).
[OFFICIAL -- EFDA Guideline on Reliance for GMP Inspection] EFDA may rely on GMP inspections performed by recognised authorities and WHO Prequalification.

1.3 GMP
[OFFICIAL -- EFDA GMP Inspection Procedure Directive No. 1055/2025; EFDA Medicine Good Manufacturing Practice (MGMP) Guideline; GMP Guideline 4th Edition; GMP Inspection Manual] GMP inspections are conducted under Directive No. 1055/2025. EFDA maintains a GMP Guideline (4th Edition), a Medicine GMP guideline, a GMP Inspection Manual, a Guideline for Remote GMP Inspection, and a dedicated GMP Guideline for Herbal Medicine. A Good Laboratory Practice Guideline and a Guideline for Quality Agreement in pharmaceutical contract manufacturing (version 002, 2025) also apply.
[OFFICIAL -- Regulation No. 370/2015, Schedule 18, Rate of Service Fees] Foreign GMP inspection fees (USD, per production institution / one production place / up to two production lines): East African countries 5,400; other African countries 6,930; Middle East countries 7,750; manufacturers in Europe without an SRA GMP certificate 7,750; manufacturers in North America without an SRA GMP certificate 8,950. A desk audit of companies that hold a GMP certificate from a strong regulatory authority and intend to import is 3,500. Each additional production line beyond four adds 1,500. Raw-material/finished-product warehouse 3,000; packaging-of-finished-product, QC and distribution licence 2,500; QC and distribution licence 2,000. A priority service in relation to medicines registration is charged at double the fee.

1.4 VARIATIONS AND RENEWAL
[OFFICIAL -- EFDA Guideline on Variation Applications to Registered Medicines (2 November 2023); EFDA Guideline on Variation Applications to Registered Vaccines (2024)] Post-approval changes follow dedicated variation guidelines for medicines and for vaccines.
[OFFICIAL -- EFDA Guideline for Renewal of Marketing Authorization, EFDA/GDL/018 version 003, approved 5 December 2023] Renewal of marketing authorization follows EFDA/GDL/018.

1.5 IMPORT
[OFFICIAL -- EFDA Guideline on Medical Products Special Import Permit (21 December 2023)] A Special Import Permit pathway governs the import of medical products outside routine registration.
[OFFICIAL -- EFDA Medicine and Medical Device Import, Export and Wholesale Control Directive No. 872/2022; EFDA Guideline for Medicine and Medicine Raw Material Port Clearance, version 001, 2025] Import, export and wholesale of medicines and medical devices are controlled under Directive No. 872/2022; a dedicated 2025 guideline governs port clearance of medicines and medicine raw materials.
[OFFICIAL -- EFDA Narcotic and Psychotropic Medicine Control Directive No. 1121/2018] Narcotic and psychotropic medicines are controlled under Directive No. 1121.
[OFFICIAL -- Regulation No. 370/2015, Schedules 9 and 10] Port-of-entry import inspection fees (Birr): medicines and medicine raw materials 350; medical devices 350; cosmetics and cosmetics raw materials 350; airplane fumigation 350; dead-body control 150. Port-of-exit export inspection fees (Birr): medicines and raw materials 150; medical devices 150; cosmetics and raw materials 150; tobacco 300.

1.6 FEES (Regulation No. 370/2015 -- Rate of Service Fees, Federal Negarit Gazette No. 22, 11 January 2016)
[OFFICIAL -- Council of Ministers Regulation No. 370/2015] This regulation determines the fees payable for registration and licensing of food, medicine, health professionals and health institutions, set out in 23 schedules. Key medicine-relevant items: Certificate of Pharmaceutical Products, Medical Supplies Free Sale Certificate and GMP certificate (Schedule 15) -- 250 Birr first issue, 200 Birr renewal (every three years) each. Consultancy-service licence for sectors under EFDA control (Schedule 17) -- 200 Birr first time, 100 Birr renewal/replacement. Medical-device and equipment dossier evaluation (Schedule 13) -- 1,300 Birr dossier evaluation, 650 Birr re-registration (every four years). Medicine laboratory-testing fees (Schedule 21, USD) range from 15 (appearance/description) to 400 (comparative chromatographic dissolution) -- e.g. assay 100-225, dissolution 200-400, related substances 50-125, sterility 200, bacterial endotoxins 150, condom testing 150-200 by batch size.

==============================================================
SECTION 2: MEDICAL DEVICES & IVDs
==============================================================
[OFFICIAL -- EFDA General Guidelines for Medical Devices Marketing Authorization; EFDA Guidelines for the Registration of Medical Devices or Supplies] Medical devices and supplies (including surgical dressings, ligatures and sutures) require marketing authorization supported by an application form, an agency agreement, a GMP certificate, a product certificate, technical documentation (manufacturing and packaging procedures, specifications, test methods, stability study report, labelling samples), and pre-clinical safety and efficacy data for new devices.
[OFFICIAL -- EFDA Guideline for Marketing Authorization of Low-risk Medical Devices; EFDA Low-Risk Medical Device Manufacturers Control Directive No. 1010/2024] Low-risk medical devices have a dedicated marketing-authorization guideline; low-risk medical-device manufacturers are controlled under Directive No. 1010/2024.
[OFFICIAL -- EFDA Guidelines for IVD Registration Requirements; EFDA Guidelines for Non-IVD Registration Requirements] Separate dossier-requirement guidelines apply to IVD and to non-IVD medical devices.
[OFFICIAL -- EFDA Guideline for Classification of In-Vitro Diagnostic Medical Devices; EFDA Guideline for Classification of Medical Devices other than IVD Medical Devices; EFDA Guidelines for Borderline Medical Devices; EFDA Medical Devices Nomenclature (Adopting Ethiopia)] Risk-classification, borderline determination and a national medical-device nomenclature are defined.
[OFFICIAL -- EFDA Guidance on Criteria for Bundling or Grouping of Medical Devices; EFDA Guideline for Application of Accessories and Spare Parts] Bundling/grouping criteria and accessory/spare-part applications have dedicated guidance.
[OFFICIAL -- EFDA Guideline for Medical Devices Good Manufacturing Practice; EFDA Guidelines for Medical Devices GMP Inspection; EFDA Guidelines for Medical Device GDP and GSP] Medical-device GMP, GMP inspection and good distribution/storage practice have dedicated guidelines.
[OFFICIAL -- EFDA Guidelines for Medical Device Labeling; EFDA Guideline on Requirements of Medical Devices Clearance at Ports of Entry] Device labelling and port-of-entry clearance are governed by dedicated guidelines.
[OFFICIAL -- EFDA Guidelines for Software as Medical Devices (SaMD)] Software as a medical device has a dedicated registration guideline.
[OFFICIAL -- EFDA Guidelines for Medical Devices Clinical Investigation Authorization; EFDA Guidelines for Medical Devices Good Clinical Practices] Clinical investigation of medical devices requires EFDA authorization and follows medical-device GCP.
[OFFICIAL -- EFDA Medical Devices Recall Guideline; EFDA Medical Devices Post-Marketing Surveillance Guideline; EFDA Medical Devices Decommissioning and Disposal Guideline; EFDA Guidelines for Medical Device Refurbishment; EFDA Guidelines for Medical Device Donations; EFDA Medical Equipment Donation Directive No. 336/2020; EFDA Guideline for Medical Device Post-approval Change Notification] Device recall, post-market surveillance, decommissioning/disposal, refurbishment, donation (Directive 336/2020) and post-approval change notification each have dedicated guidance.

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SECTION 3: COMPLEMENTARY / HERBAL
==============================================================
Herbal medicines are subject to a dedicated EFDA GMP Guideline for Herbal Medicine (see SECTION 1.3).
[OFFICIAL -- EFDA Traditional Medicinal Products Manufacturing Certificate of Competence and Market Authorization Directive No. 957; EFDA Low-Risk Traditional Medicinal Products Regulation Directive No. 1102/2017; EFDA Traditional Medicine Clinical Trial Guidance (2020); EFDA Traditional Medicine Guidance] Traditional medicinal products are regulated through dedicated directives and guidance, including a low-risk traditional-medicine directive (1102/2017) and clinical-trial guidance.
[OFFICIAL -- EFDA Food Supplement Directive No. 333/2020; EFDA Infant Formula and Follow-up Formula Directive No. 335/2020; EFDA Baby Food Control Directive No. 840/2021] Food supplements, infant/follow-up formula and baby food are regulated through dedicated directives.
[OFFICIAL -- EFDA Cosmetics Import, Export and Wholesale Control Directive No. 331/2020; EFDA Cosmetic Product Manufacturing Directive No. 49/2020; EFDA Cosmetic Product Regulation; EFDA Guideline for Registration of Antiseptics and Disinfectants; EFDA Guideline for Registration of Oral-care and Skin-care Products with Therapeutic Claim] Cosmetics, antiseptics/disinfectants and therapeutic oral-care/skin-care products are regulated through dedicated directives and guidelines.

==============================================================
SECTION 3B: BIOLOGICALS / VACCINES
==============================================================
[OFFICIAL -- EFDA Guideline for Registration of Vaccine (29 January 2024)] Vaccines have a dedicated registration guideline; variation applications to registered vaccines are governed by a dedicated 2024 guideline.
[OFFICIAL -- EFDA Guidelines for Registration of Biotherapeutic Protein Products (30 January 2024); EFDA Guidelines on Evaluation of Similar Biotherapeutics (30 January 2024); EFDA Guidelines on procedures and data requirements for changes to approved biotherapeutic products (23 January 2025)] Biotherapeutic protein products and similar biotherapeutics (biosimilars) have dedicated registration and evaluation guidelines, plus a 2025 guideline on changes to approved biotherapeutics.
[OFFICIAL -- EFDA Guideline for Registration of Monoclonal Antibodies and Related Products (2025)] Monoclonal antibodies and related products have a dedicated 2025 registration guideline.
[OFFICIAL -- EFDA Guidance for Registration of Radiopharmaceuticals; EFDA Guideline for Temporary Market Authorization of Radiopharmaceuticals] Radiopharmaceuticals have dedicated guidance including a temporary MA route.
[OFFICIAL -- EFDA Guideline for the Registration of Plasma-derived Medical Products; EFDA Good Practice Guideline for Blood Establishments, 1st Edition 2026] Plasma-derived medical products and blood establishments have dedicated guidance.
[OFFICIAL -- EFDA Guideline for Registration of Snake Antivenom Products, 1st Version 2026] Snake antivenom products have a dedicated 2026 registration guideline.
[OFFICIAL -- EFDA Guideline for Emergency Use Authorization of Vaccines and Therapeutics for Marburg Virus Disease, version 001, 2025; EFDA Risk Management Plan Guideline for COVID-19 Vaccines] Emergency use authorization of vaccines/therapeutics (e.g. for Marburg virus disease) and vaccine risk-management planning have dedicated guidance.

==============================================================
SECTION 4: CLINICAL TRIALS
==============================================================
[OFFICIAL -- EFDA Clinical Trial Directive No. 964/2023] Clinical trials are governed by Directive No. 964/2023.
[OFFICIAL -- EFDA Guideline for Clinical Trial Authorization, 2025 version 005] Clinical-trial authorization follows the 2025 version-005 guideline (with a Clinical Trial Application form and an application processing-flow diagram; a non-routine clinical-trial application screening form also exists).
[OFFICIAL -- EFDA Guideline for Good Clinical Practice, 2025 version 004; EFDA Guideline for Good Clinical Practice Inspection, 2025 version 002] Good clinical practice and GCP inspection follow the 2025 guidelines.
[OFFICIAL -- EFDA Guideline for Bioequivalence Studies, 2025 version 002] Bioequivalence studies follow the 2025 version-002 guideline.
[OFFICIAL -- EFDA Guideline for reliance and joint clinical trial application (2025)] A reliance and joint-review pathway exists for clinical trial applications.
[OFFICIAL -- Regulation No. 370/2015, Schedule 19] Clinical Trial Control fees (USD): a clinical trial application is 3,000; a lower-tier category 1,500; a technical or major change to a clinical trial 500; a minor item 100.

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SECTION 5: POST-MARKET / PHARMACOVIGILANCE
==============================================================
[OFFICIAL -- EFDA Pharmacovigilance Guideline; EFDA National Pharmacovigilance Roadmap 2020] Pharmacovigilance is governed by a dedicated guideline and a national roadmap; disease-specific PV guidelines exist (antimalarial, HIV, TB, NCD, NTD).
[OFFICIAL -- EFDA Adverse Event Following Immunization (AEFI) Guideline; EFDA AEFI Surveillance Guideline Addendum 2022; EFDA Vaccine Safety Risk and Crisis Communication Guideline] AEFI surveillance and vaccine-safety crisis communication have dedicated guidance.
[OFFICIAL -- EFDA Guideline for Consumer Reporting of Adverse Drug Events (English Version); EFDA Guideline for prevention, detection and response to Substandard and Falsified (SF) medical products] Consumer ADE reporting and SF-product response have dedicated guidance.
[OFFICIAL -- EFDA GDP, GSP and Re-call Guideline (Revised 2nd Edition); EFDA Medicines Waste Management and Disposal Directive; EFDA Medicine Donation Control Directive No. 958/2023; EFDA Guideline for control of advertising and promotion (11 January 2024)] Good distribution/storage practice and recall, waste disposal, medicine donations (Directive 958/2023) and advertising/promotion control are governed by dedicated documents.
[OFFICIAL -- EFDA Good Review Practice Guideline; EFDA Guideline for Risk Management Process for Regulatory Systems, version 002, 2025; EFDA Master Data Guideline 2nd Edition 2024; EFDA Pharmaceutical Products Barcoding Guideline] EFDA also publishes good-review-practice, regulatory risk-management, master-data and barcoding guidelines.

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SECTION 6: KEY TIMELINES
==============================================================
EFDA registration processing timelines are not stated in the fee regulation; the EFDA registration and reliance guidelines (SECTION 1) govern review steps. The Rate of Service Fees Regulation No. 370/2015 is the governing fee instrument (gazetted January 2016) -- applicants should confirm whether a more recent fee schedule has superseded it.

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GUIDELINE INDEX
==============================================================
LEGISLATION & DIRECTIVES: Food and Medicine Administration Proclamation No. 1112/2019; Council of Ministers Regulation No. 299/2013; Rate of Service Fees Regulation No. 370/2015; Medicine Marketing Authorization Directive No. 963/2023; Clinical Trial Directive No. 964/2023; Medicine and Medical Device Import, Export and Wholesale Control Directive No. 872/2022; Narcotic and Psychotropic Medicine Control Directive No. 1121/2018; Low-Risk Medical Device Manufacturers Control Directive No. 1010/2024; Medical Equipment Donation Directive No. 336/2020; Medicine Donation Control Directive No. 958/2023; Food Supplement Directive No. 333/2020; Infant Formula Directive No. 335/2020; Cosmetics Directives No. 331/2020 and No. 49/2020; Traditional Medicinal Products Directive No. 957; Low-Risk Traditional Medicinal Products Directive No. 1102/2017; GMP Inspection Procedure Directive No. 1055/2025; Medicines Waste Management and Disposal Directive.
MEDICINE GUIDELINES: Registration of Medicine (EFDA/GDL/017 v005; 1 March 2024); Registration of Low-risk Medicines; Non-Routine Registration (EFDA/GDL/024 v001); Conditional Approval; Reliance for Marketing Authorization (EFDA/GDL/042 v003, 2024); WHO PQ via Collaborative Registration Procedure; Reliance for GMP Inspection; Variation Applications to Registered Medicines; Renewal of Marketing Authorization (EFDA/GDL/018 v003); Special Import Permit; Medicinal Gases Registration / Temporary MA; role and responsibilities of MA holder; preparation and publication of public assessment reports; Medicinal Product Information; Drug Information Service (2nd Version 2025).
GMP & QUALITY: GMP Guideline 4th Edition; Medicine GMP (MGMP); GMP Inspection Manual; Remote GMP Inspection; GMP Guideline for Herbal Medicine; Good Laboratory Practice Guideline; Quality Agreement in pharmaceutical contract manufacturing (v002, 2025); Good Review Practice; Risk Management Process for Regulatory Systems (v002, 2025).
MEDICAL DEVICES & IVDs: General Guidelines for Medical Devices Marketing Authorization; Registration of Medical Devices or Supplies; Marketing Authorization of Low-risk Medical Devices; IVD and Non-IVD Registration Requirements; Classification of IVD and of non-IVD Medical Devices; Borderline Medical Devices; Medical Devices Nomenclature; Bundling/Grouping criteria; Accessories and Spare Parts; Medical Devices GMP and GMP Inspection; Medical Device GDP and GSP; Medical Device Labeling; Clearance at Ports of Entry; Software as Medical Devices; Clinical Investigation Authorization; Medical Devices Good Clinical Practices; Recall; Post-Marketing Surveillance; Decommissioning and Disposal; Refurbishment; Donations; Post-approval Change Notification.
BIOLOGICALS: Registration of Vaccine; Variation Applications to Registered Vaccines; Registration of Biotherapeutic Protein Products; Evaluation of Similar Biotherapeutics; changes to approved biotherapeutic products (2025); Registration of Monoclonal Antibodies (2025); Registration of Plasma-derived Medical Products; Good Practice Guideline for Blood Establishments (2026); Registration of Snake Antivenom (2026); Registration of Radiopharmaceuticals and Temporary MA; EUA for Marburg Virus Disease (2025); RMP Guideline for COVID-19 Vaccines.
CLINICAL TRIALS: Clinical Trial Authorization (2025 v005); Good Clinical Practice (2025 v004); GCP Inspection (2025 v002); Bioequivalence Studies (2025 v002); reliance and joint clinical trial application (2025); Clinical Trial Application form and processing-flow diagram.
PHARMACOVIGILANCE & POST-MARKET: Pharmacovigilance Guideline; National Pharmacovigilance Roadmap 2020; disease-specific PV guidelines (antimalarial, HIV, TB, NCD, NTD); AEFI Guideline and 2022 Addendum; Vaccine Safety Risk and Crisis Communication; Consumer Reporting of ADEs; prevention/detection/response to SF products; GDP/GSP and Re-call Guideline; advertising and promotion control.
TRACEABILITY: Master Data Guideline; Pharmaceutical Products Barcoding Guideline; GLN and GTIN Allocation Guidelines.

[GAP] EFDA medicine registration dossier-evaluation fees (Regulation 370/2015 Schedule 13 -- new chemical / generic-with-bioequivalence rows) are OCR-garbled in the scanned regulation and could not be reliably read; EFDA registration processing timelines and pharmacovigilance reporting timelines were not stated in the documents processed -- verify these directly with EFDA, and confirm whether a fee schedule more recent than Regulation 370/2015 (gazetted January 2016) is in force.

==============================================================
SHAAMI BOTSWANA REGULATORY KNOWLEDGE BASE -- BOMRA
Regulator: Botswana Medicines Regulatory Authority (BOMRA)
Legal basis: Medicines and Related Substances Act, 2025 (Act No. 29 of 2025); Human Medicines Regulations, 2026
Address: Gaborone, Botswana
Website / portal: www.bomra.co.bw
NRA maturity: BOMRA is a ZAZIBONA member (SADC collaborative medicines registration initiative)
Sources: BOMRA guideline suite; Human Medicines Regulations 2026
Last updated: 17 May 2026
==============================================================

REGULATOR AND PORTALS
Botswana Medicines Regulatory Authority (BOMRA). BOMRA is a member of the ZAZIBONA collaborative medicines registration initiative (SADC), which is strategically important for multi-country SADC market entry.

LOCAL REPRESENTATIVE
A local representative is required for foreign manufacturers seeking BOMRA registration.

==============================================================
SECTION 1: MEDICINES
==============================================================
1.1 REGISTRATION
[OFFICIAL -- Human Medicines Regulations, 2026 (Statutory Instrument under the Medicines and Related Substances Act, 2025, Act No. 29 of 2025)] Marketing authorisation is required before a human medicine may be placed on the Botswana market. The Regulations define registration pathways, application, screening and validation, assessment, registration conditions, validity and renewal, and variations. Dedicated parts cover: new chemical entities and new biological entities (with data protection); generic medicines (application requirements, bioequivalence studies, biowaivers, interchangeability and substitution); biosimilar medicines (comparability studies, extrapolation of indications, naming and labelling); fixed-dose combinations (with therapeutic justification); orphan medicines (orphan designation and incentives); and controlled medicines.
[OFFICIAL -- BOMRA Guideline for the Renewal of Registration for Human Medicines, BOMRA/ER/MD/P11/G01 Issue 3.0, effective 1 September 2023] Renewal of a human-medicine registration follows this guideline.
[OFFICIAL -- BOMRA Guideline for Variation of Human Medicines, BOMRA/ER/MD/P04/G03 Issue 3] Post-approval variations to registered human medicines follow this guideline.

1.2 RELIANCE
[OFFICIAL -- BOMRA Guideline on Reliance and Recognition of Information from Regional and International Bodies, Issue 3.0] BOMRA applies reliance and recognition of regulatory information from regional and international bodies in its decision-making. As a ZAZIBONA member it participates in SADC work-sharing for medicines registration and GMP inspection; a separate guideline covers recognition and reliance on information from veterinary-medicine NRAs.

1.3 GMP AND MANUFACTURING
[OFFICIAL -- BOMRA Guideline for Good Manufacturing Practice, BOMRA/IL/IL/P08/G01 Issue 2.1, effective 20 April 2026] GMP compliance is required. Under the Human Medicines Regulations 2026 a manufacturing licence is required, with defined licence categories, key-personnel requirements, GMP compliance, a GMP certificate of compliance, contract-manufacturing provisions and local-manufacturing incentives. A Guideline for Classification of GXP Deficiencies is also published.

1.4 IMPORT AND EXEMPTIONS
[OFFICIAL -- BOMRA Guideline for Importation of Medicines for Personal Use; BOMRA Guideline for Submission of Applications for Exemption from Registration] Personal-use medicine importation and exemption-from-registration applications follow dedicated BOMRA guidelines.

==============================================================
SECTION 2: MEDICAL DEVICES & IVDs
==============================================================
[OFFICIAL -- BOMRA medical-device guideline suite] BOMRA regulates medical devices and IVDs through: the Guideline for Application for Registration of Medical Devices; the Guideline for Application for Registration of IVDs; the Guideline for Medical Device Classification (BOMRA/ER/MED/P04) and the Guideline for IVD Medical Device Classification; the Guideline for Notification for Registration of Medical Devices; the Variation Guidelines for Medical Devices; and the Guideline for Labelling of Medical Devices including IVDs. Considerations for the regulation of MNCH (maternal, newborn and child health) medical devices are also published.

==============================================================
SECTION 3: COMPLEMENTARY / HERBAL
==============================================================
[OFFICIAL -- BOMRA Guideline for Application for Registration of Complementary Medicines] Complementary medicines have a dedicated registration guideline. Veterinary medicinal products are regulated separately, with guidelines for registration of pharmaceutical VMPs, immunological VMPs and complementary veterinary medicines, plus VMP variation and renewal guidelines.

==============================================================
SECTION 3B: BIOLOGICALS / VACCINES
==============================================================
Biosimilar medicines and new biological entities are regulated within the Human Medicines Regulations 2026 -- comparability studies, extrapolation of indications, naming and labelling, and data protection (see SECTION 1.1).

==============================================================
SECTION 6: KEY TIMELINES
==============================================================
BOMRA registration processing timelines were not extracted in this pass (see gap note below).

==============================================================
GUIDELINE INDEX
==============================================================
Human Medicines Regulations, 2026 (under Act No. 29 of 2025)
BOMRA/ER/MD/P11/G01 Issue 3.0 (1 Sep 2023) -- Renewal of Registration for Human Medicines
BOMRA/ER/MD/P04/G03 Issue 3 -- Variation of Human Medicines
BOMRA Guideline on Reliance and Recognition of Information from Regional and International Bodies, Issue 3.0
BOMRA/IL/IL/P08/G01 Issue 2.1 (20 Apr 2026) -- Good Manufacturing Practice; Guideline for Classification of GXP Deficiencies
BOMRA medical-device guideline suite: Registration of Medical Devices; Registration of IVDs; Medical Device Classification (BOMRA/ER/MED/P04); IVD Medical Device Classification; Notification for Registration of Medical Devices; Variation Guidelines for Medical Devices; Labelling of Medical Devices including IVDs
BOMRA Guideline for Application for Registration of Complementary Medicines; veterinary-medicine guideline suite
BOMRA Guideline for Importation of Medicines for Personal Use; Guideline for Submission of Applications for Exemption from Registration

[GAP] BOMRA fee-schedule amounts and registration processing timelines were not extracted in this pass -- verify directly with BOMRA.

==============================================================
SHAAMI MOZAMBIQUE REGULATORY KNOWLEDGE BASE -- ANARME
Regulator: Autoridade Nacional Reguladora de Medicamentos, I.P. (ANARME)
Legal basis: [OFFICIAL -- Lei n.º 12/2017 de 8 de Setembro (Boletim da República I Série No. 141), Law on Medicines, Vaccines and Other Biological Products for Human Use; revokes Lei n.º 4/98 of 14 January] [OFFICIAL -- Decreto n.º 93/2018 de 31 de Dezembro, Regulation on Authorisation of Introduction in the Market of Medicines, Vaccines and Other Biological Products for Human Use] [OFFICIAL -- Decreto n.º 19/2023 de 02 de Maio, Regulation on Authorisation of Introduction in the Market of Health Products and Phytotherapeutic and Homeopathic Medicines (covers medical devices, IVDs, phytotherapeutic and homeopathic medicines)]
Address: Maputo, Mozambique (Sede e Direcções Regionais Norte/Centro/Sul -- DRN/DRC/DRS)
Website: https://anarme.gov.mz
Portal: WP Download Manager-based document portal at anarme.gov.mz/manuais-guioes-directrizes/, /circulares/, /modelos-e-formularios/, /boletins/, /listas/
NRA maturity: [FIELD -- USP PQM+ country page (usp-pqmplus.org/where-we-work/mozambique) accessed 2026-05-30] ANARME is working toward WHO GBT ML3 with PQM+ support and is not yet on the published ML3 list (as of WHO benchmarking summary January 2025 the eight ML3 African NRAs are Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Zimbabwe -- Mozambique not yet listed). ANARME maintains ISO 9001:2015 certification; LNCQ (Laboratório Nacional de Comprovação da Qualidade, the national medicines quality-control laboratory under ANARME) is working toward ISO/IEC 17025:2017 accreditation.
Regional memberships: SADC member [OFFICIAL -- ra8310-annex-iv_sadc-ctd-format-v02_aug2014-portuguese (ANARME applies the SADC CTD format)]. ZAZIBONA active member [FIELD -- ZAZIBONA portal (zazibona.com) and multiple SADC-MRH publications accessed 2026-05-30] confirm Mozambique among the nine active ZAZIBONA NRAs (the others: Botswana, DRC, Malawi, Namibia, South Africa, Tanzania, Zambia, Zimbabwe). The "Processo Colaborativo" tier at 50,000 MT in Diploma Ministerial 15/2023 corresponds to this ZAZIBONA work-sharing pathway. ANARME participates in the SADC Medicines Regulatory Harmonization (SADC-MRH) programme. [GAP] Mozambique's AMA Treaty (African Medicines Agency) ratification status was not confirmed in the documents reviewed -- to be verified directly with the AU treaty database.
Sources: Lei 12/2017; Decreto 93/2018; Decreto 19/2023; Diploma Ministerial 15/2023 de 20 de Janeiro (fee schedule); Manual de Procedimentos de AIM (ANARME.MAM.DVAM V.001 v.00 2024); SADC CTD format Annex IV v02 Aug 2014; Lista Prioritária de Dispositivos Médicos Versão 00 Agosto 2025; Manual de Notificação de Ensaios Clínicos; Manual de Boas Práticas de Farmacovigilância (2 volumes -- one for ANARME, one for AIM holders)
Last updated: 2026-05-30
==============================================================

REGULATOR AND PORTALS
ANARME (Autoridade Nacional Reguladora de Medicamentos, I.P.) was created as the national medicines regulatory authority of Mozambique. It operates under the Ministry of Health (Ministério da Saúde) and is jointly co-tutoral with the Ministry of Economy and Finance for fee matters. Headquarters in Maputo with three regional directorates (DRN -- Norte, DRC -- Centro, DRS -- Sul).
Submission portal: ANARME publishes guidelines, circulars, forms and lists at https://anarme.gov.mz with sections for /manuais-guioes-directrizes/ (guidelines and procedural manuals), /circulares/ (regulatory circulars), /modelos-e-formularios/ (forms and templates), /boletins/ (pharmacovigilance bulletins), /listas/ (authorised products / cancelled products / inspector lists). The portal uses the WordPress Download Manager plugin (URLs of the shape /download/<slug>/?wpdmdl=<id>). [OFFICIAL -- ANARME public portal observed 2026-05-30]
Currency: Metical (MT, Mozambican Metical). All ANARME fees are denominated in MT.
Registration certificate validity: [GAP] AIM certificate validity period not explicitly stated in the fee schedule -- to be confirmed from the Manual de Procedimentos. The fee schedule provides for "Renovação de AIM" (renewal) which implies a finite validity, and an annual retention fee (Taxa Anual de Retenção) of 2,500 MT for imported products and 2,000 MT for products manufactured in Mozambique.

LOCAL REPRESENTATIVE
A Mozambican-registered company is mandatory for AIM applications. [OFFICIAL -- Manual de Procedimentos de AIM (ANARME.MAM.DVAM V.001 v.00 2024), Section 1.1.1 NB: "O requerente deve ser empresa registada e com sede em Moçambique" -- The applicant must be a company registered and headquartered in Mozambique]
Letter of Representation (Carta de Representatividade) is required when applicable -- this is the document by which the foreign manufacturer authorises the Mozambican entity to act as its local representative. [OFFICIAL -- Manual de Procedimentos de AIM, Module 1, Item 1.2.3]
Importer and distributor licensing is separate and required for those activities: Importer licence 150,000 MT; Distributor licence 120,000 MT; annual retention 10% of the licensing fee; renewal 30% of the licensing fee. [OFFICIAL -- Diploma Ministerial n.º 15/2023, Section 2.1.1.3]
[FIELD] In practice, the local representative for foreign manufacturers is a Mozambican-registered pharmaceutical company that holds the importer or distributor licence and is named as the AIM applicant on the dossier. Establishing a Mozambican subsidiary or contracting an established local distributor are the two standard options.

SECTION 1: MEDICINES (HUMAN)

1.1 Registration pathways
ANARME operates four AIM (Autorização de Introdução no Mercado -- Marketing Authorisation) pathways, distinguished in both the fee schedule and the procedural manuals. [OFFICIAL -- Diploma Ministerial n.º 15/2023 de 20 de Janeiro, Section 1.1; Manual de Procedimentos de AIM V.001 v.00 2024]

a) Processo Completo (Complete / full procedure) -- a full CTD dossier review. Used for new chemical entities and any product not eligible for an abbreviated, recognition or collaborative pathway. Procedural manual: "Protocolo de Recepção e Validação de um Processo de Pedido de AIM Completo no Formato CTD" (ANARME.MAM.DVAM V.001 v.00 2024).
b) Processo Abreviado (Abridged procedure) -- a reduced-scope CTD review. Procedural manual: "Protocolo de Recepção e Validação de um Processo de Pedido de AIM Abreviado no Formato CTD" (ANARME.MAM.DVAM V.001 v.00 2024).
c) Processo por Reconhecimento (Recognition / reliance procedure) -- ANARME relies on the assessment of another stringent / recognised regulatory authority. Procedural manual: "Protocolo de Recepção e Validação de um Processo de Pedido de AIM por Reconhecimento ou Colaborativo no Formato CTD" (ANARME.MAM.DVAM V.001 v.00 2024). Reliance is applied as a fee-reduced pathway and at lower documentary burden.
d) Processo Colaborativo (Collaborative procedure) -- a work-sharing pathway covered by the same recognition/collaborative protocol manual. The fee is set lower than recognition, which is consistent with regional collaborative-review schemes such as SADC ZAZIBONA where the regulatory work is shared across the SADC NRAs.

1.2 Recognised reference authorities and reliance
[OFFICIAL -- Circular n.º 07/2025 (ANARME -- Reconhecimento da Farmacopeia Indiana) confirms recognition of the Indian Pharmacopoeia for quality testing purposes]
[OFFICIAL -- ANARME applies the SADC CTD format (Annex IV of the SADC Application Form package, v02 August 2014; ANARME publishes both the original English version and a Portuguese translation), which is the same dossier format used by other ZAZIBONA member NRAs including SAHPRA, MCAZ, TMDA and BOMRA]
[FIELD] Recognition / reliance is the fee-discounted pathway: 70,000 MT vs 90,000 MT for Processo Completo (imported, per form/dosage/presentation). Collaborative is set even lower at 50,000 MT, signalling that ZAZIBONA-type work-shared dossiers carry both reduced documentation and reduced fees.
[GAP] The specific list of "stringent" reference authorities accepted by ANARME for the Reconhecimento (recognition) pathway is not enumerated in the materials reviewed in this pass. [FIELD -- ANARME public page anarme.gov.mz/autorizacao-de-entrada-no-mercado-aim/ accessed 2026-05-30] does identify accepted reference products for bioequivalence purposes: "medicamento inovador, medicamento de referência listado no Orange Book da USFDA, medicamentos de referência listados pela OMS e pelas autoridades reconhecidas por Moçambique" (innovator medicine; reference listed in the USFDA Orange Book; WHO-listed reference; reference listed by authorities recognised by Mozambique). The exact list of "autoridades reconhecidas por Moçambique" (authorities recognised by Mozambique) for the reliance pathway itself is referenced but not enumerated on the public page.

1.3 Fees -- medicines [OFFICIAL -- Diploma Ministerial n.º 15/2023 de 20 de Janeiro, Boletim da República I Série n.º 14 de 20 de Janeiro de 2023; revogates Diploma Ministerial n.º 125/2008]
All fees in Metical (MT). 40% of receipts go to the State Budget and 60% to ANARME.IP.

AIM -- Imported medicines, vaccines and other biological products:
- Processo Completo: per form, dosage and presentation 90,000 MT; each supplementary dosage 48,500 MT; each additional presentation 7,500 MT.
- Processo Abreviado: per form and dosage 62,000 MT; each supplementary dosage 36,500 MT; each additional presentation 7,500 MT.
- Processo por Reconhecimento: per form, dosage and presentation 70,000 MT; each supplementary dosage 36,500 MT; each additional presentation 7,500 MT.
- Processo Colaborativo: per form, dosage and presentation 50,000 MT; each supplementary dosage 36,500 MT; each additional presentation 7,500 MT.

AIM -- Medicines manufactured in Mozambique (Processo Completo and Processo Abreviado, single tier):
- Per form, dosage and presentation 40,000 MT; each supplementary dosage 28,500 MT; each additional presentation 7,500 MT.

Post-AIM:
- Renewal of AIM, imported product: 31,000 MT.
- Renewal of AIM, locally manufactured product: 25,000 MT.
- Annual retention fee per imported product: 2,500 MT.
- Annual retention fee per locally manufactured product: 2,000 MT.
- Transfer of AIM from one company to another, per product: 15,000 MT.
- Second copy of AIM certificate: 10,000 MT.
- Certificate of Pharmaceutical Product (CPP) issuance: 20,000 MT.

1.4 GMP requirements and inspection fees [OFFICIAL -- Diploma Ministerial n.º 15/2023, Sections 2.1.1.2.1 and 2.1.1.2.2]
GMP certification for LOCAL Mozambican manufacturers:
- One production line: 230,000 MT.
- Two production lines: 300,000 MT.
- Three or more production lines: 500,000 MT.
- Addition of new products to the portfolio (same line): 30,000 MT.

GMP inspection of FOREIGN manufacturing sites (anywhere in the world), per inspector, per site:
- Travel-and-work fee per inspector: 6,400 MT per hour (working hours and travel hours are calculated separately).
- Documentary evaluation fee per manufacturing site: 200,000 MT.

[GAP] Whether GMP inspection is mandatory before first AIM grant or whether ANARME accepts WHO PQ / PIC/S / SRA GMP certificates for waiver is not explicit in the fee schedule alone -- to be confirmed from the Manual de Procedimentos de Inspecção (referenced as fetch-failed during scrape) and the AIM por Reconhecimento manual.

1.5 Renewal of registration [OFFICIAL -- Manual: "Protocolo de Recepção e Validação de um Processo de Pedido de Renovação de AIM no Formato CTD" (ANARME.MAM.DVAM V.001 v.00 2024); fee: Diploma Ministerial 15/2023 Section 1.1.3]
Renewal fees: 31,000 MT imported, 25,000 MT local. Annual retention fees of 2,500 MT (imported) / 2,000 MT (local) apply between renewals.
[GAP] AIM validity period (5 years vs other) and the renewal lead-time and documentation list are in the procedural manual; not extracted in this pass.

1.6 Variations and amendments [OFFICIAL -- "Check-list de Alterações e Emendas" (ANARME forms portal)]
A formal variation framework exists; the public check-list lists the documents required for an alteration/amendment submission. [GAP] The classification of variations (minor / major / notification) and their respective fees and timelines is not extracted -- only clinical-trial protocol amendments are listed in the fee schedule (5,000 MT minor, 10,000 MT major; see Section 4).

1.7 Import / export and authorised ports [OFFICIAL -- Diploma Ministerial n.º 15/2023, Section 2.2.5; Circular n.º 15/2025 -- ANARME DVIL Cronograma de Tramitação dos Processos de Importação e Libertação]
Import/export fees:
- Special Import Request per product: varies between 5,000 MT and 20,000 MT.
- BIEF approval for finished pharmaceutical products by the private sector: 2% of the invoice value.
- BIEF approval for finished pharmaceutical products by the public sector (Central de Medicamentos e Artigos Médicos): 0.5% of the invoice value.

BIEF = Boletim de Importação e Exportação Farmacêutica (Pharmaceutical Import and Export Authorisation). The Special Import Request form ("Anexo VI -- Formulário para Importação Especial ANARME") is the document for one-off / exceptional imports outside the normal AIM-based supply chain.

[FIELD] The ANARME DVIL (Direcção de Vigilância e Inspecção Farmacêutica) issued Circular n.º 15/2025 on the timeline-schedule (cronograma) for processing import and release of pharmaceutical products, indicating that import processing timelines are published rather than ad-hoc.

1.8 Site Master File
[GAP] Site Master File requirements for foreign manufacturers not extracted; SADC CTD Module 1 / Module 3.2.A.1 is the standard location and ANARME applies the SADC CTD.

1.9 Establishment / manufacturer / wholesaler / importer licensing [OFFICIAL -- Diploma Ministerial n.º 15/2023, Sections 2.1.1.1, 2.1.1.3, 2.1.1.4]
LOCAL pharmaceutical industry licensing (per production line):
- Licensing fee: 1% of the total project implementation investment.
- Annual retention fee: 100,000 MT.
- Licence renewal: 50% of the licensing fee.

Importer/distributor licensing: Importer 150,000 MT; Distributor 120,000 MT; annual retention 10% of licensing; renewal 30% of licensing.

Pharmacy and sales-outlet licensing:
- Pharmacy Level A: 75,000 MT.
- Pharmacy Level B: 50,000 MT.
- Pharmacy Level C: 25,000 MT.
- Pharmacy in Maputo City "Zona Cimento": 250,000 MT.
- Medicines and health-product sales outlets (Postos de Venda): 10,000 MT.
- Commercial establishments selling medicines (Rede Comercial): 100,000 MT.
- Annual retention 10% of licensing; renewal 50% of licensing.

SECTION 2: MEDICAL DEVICES AND IVDs [OFFICIAL -- Decreto n.º 19/2023 de 02 de Maio, Regulation on Authorisation of Introduction in the Market of Health Products and Phytotherapeutic and Homeopathic Medicines; "Lista Prioritária de Dispositivos Médicos (DM) e Dispositivos Médicos de Diagnóstico In-Vitro (DIVs) Sujeitos ao Registo", ANARME Versão 00, August 2025]

Definitional framework: A medical device (DM) is defined in Decree 19/2023 broadly as any instrument, apparatus, equipment, software, material or article (alone or in combination, including software intended by the manufacturer specifically for diagnostic or therapeutic purposes) intended by the manufacturer for use in humans for: diagnosis, prevention, control, treatment or alleviation of disease; diagnosis, control, treatment, alleviation or compensation of injury or disability; investigation, replacement or modification of anatomy or of a physiological process; or control of conception -- whose principal intended effect in the human body is not achieved by pharmacological, immunological or metabolic means, although its function may be assisted by such means.

Scope of regulation: ANARME publishes a Lista Prioritária (priority list) of DMs and DIVs subject to registration, indicating a phased/risk-tiered approach to device regulation. Devices outside the priority list may be subject to notification rather than full registration. [OFFICIAL -- Lista Prioritária, Versão 00, August 2025]

Pathways available for devices:
a) Notification -- forms exist: "Formulário de Pedidos de Notificação para AIM de DM e DIVs" (notification form for devices and IVDs).
b) Full / collaborative AIM -- check-lists exist: "Lista de verificação de um processo de pedido de AIM de Dispositivo Médico e DIVs" (collaborative procedure check-list); "Lista de verificação de um processo de pedido de AIM de Dispositivo Médico de Diagnóstico in vitro" (DIV-specific check-list).
c) Renewal -- "Lista de verificação de um processo de renovação do de AIM do Dispositivo Médico e DIV".

[GAP] Specific device class fees, conformity assessment requirements per class, and ISO 13485 mandation are not explicit in the materials reviewed in this pass -- to be extracted from the device-specific Manual de Procedimentos which fetch-failed during scrape (manuals listed under /manuais-guioes-directrizes/ for devices). The fee tier for devices appears to fall under the general "Other authorisations under Decree 93/2018" of 5,000 -- 180,000 MT in Diploma Ministerial 15/2023 section 4; the Decree 19/2023 may publish a separate device fee schedule (not yet extracted).

SECTION 3: COMPLEMENTARY / HERBAL / SUPPLEMENTS [OFFICIAL -- Decreto n.º 19/2023 de 02 de Maio covers Medicamentos Fitoterápicos (phytotherapeutic medicines) and Homeopáticos (homeopathic medicines)]
ANARME regulates phytotherapeutic and homeopathic medicines under Decree 19/2023. A specific check-list exists: "Check-list de Fitoterápicos e Homeopáticos" (ANARME forms portal).
[GAP] Detailed pathway, dossier, fee and timeline for phytotherapeutic / homeopathic / supplement products not extracted in this pass.

SECTION 3B: BIOLOGICALS / VACCINES [OFFICIAL -- Lei n.º 12/2017 de 8 de Setembro; Decreto n.º 93/2018 de 31 de Dezembro]
Biologicals and vaccines are explicitly within the scope of Decree 93/2018 ("Medicamentos, Vacinas e Outros Produtos Biológicos para Uso Humano"). Fees are the same as for imported medicines (Section 1.3 above): Processo Completo 90,000 MT per form/dosage/presentation, etc.
[OFFICIAL -- Manual de Procedimentos de AIM Module 1.2.6 references "Cópia de certificado de EMA do dossier mestre do antígeno da vacina (VAMF)" -- i.e. ANARME accepts EMA VAMF certificates for vaccines]
[GAP] Lot release, RMP, Plasma Master File (PMF), and biosimilar-specific requirements are not extracted in this pass.

SECTION 4: CLINICAL TRIALS [OFFICIAL -- Manual de Notificação de Ensaios Clínicos (ANARME); "Checklist para a Realização de Ensaios Clínicos"; Diploma Ministerial n.º 15/2023 Section 3]

Authorisation regime: Clinical trials require ANARME authorisation. Two registers exist: trials conducted by Government institutions, and trials conducted by Non-Governmental Organisations -- the fee schedule differentiates between the two.

Fee schedule (in MT):
For Government-institution trials:
- Trial by foreign individual investigator: 150,000 MT.
- Trial by national individual investigator: 110,000 MT.
- Foreign-promoter trial -- Phase 1: 250,000 MT, Phase 2: 195,000 MT, Phase 3: 145,000 MT.
- National-promoter trial -- Phase 1: 135,000 MT, Phase 2: 112,500 MT, Phase 3: 97,500 MT.

For NGO-conducted trials:
- Trial by foreign individual investigator: 180,000 MT.
- Trial by national individual investigator: 130,000 MT.
- Foreign-promoter trial -- Phase 1: 250,000 MT, Phase 2: 220,000 MT, Phase 3: 190,000 MT.
- National-promoter trial -- Phase 1: 180,000 MT, Phase 2: 150,000 MT, Phase 3: 130,000 MT.

Trial amendments:
- Administrative amendments and other minor amendments: 5,000 MT.
- Major protocol or Investigator's Brochure amendments: 10,000 MT.
- Annual revalidation / renewal of the protocol: 10,000 MT.

[OFFICIAL -- a Manual Operativo da Área de Ensaios Clínicos da ANARME exists (referenced in portal but fetch-failed during scrape)]
[GAP] Ethics-committee approval pathway, GCP standard applied, investigator residency and liability-insurance requirements not extracted in this pass.

SECTION 5: POST-MARKET / PHARMACOVIGILANCE [OFFICIAL -- Manual de Boas Práticas de Farmacovigilância (ANARME); Manual de Boas Práticas de Farmacovigilância para Titulares de AIM (Manual for AIM holders); Boletim de Farmacovigilância published semestrally and annually by ANARME (2022, 2023, 2024, 2025 editions inventoried in the portal)]

ANARME operates a Centro Nacional de Farmacovigilância (National Pharmacovigilance Centre) and publishes both an internal Manual de Boas Práticas de Farmacovigilância (GVP for ANARME staff) and a separate Manual de Boas Práticas de Farmacovigilância para Titulares de AIM (GVP for AIM holders / manufacturers).
A "Folheto" (information sheet) for the Centro Nacional de Farmacovigilância is publicly available, indicating active public-facing pharmacovigilance communication.
A "Guião sobre os requisitos, competências e necessidades de treinamento dos técnicos de farmacovigilância" (Guide on requirements, competencies and training needs for pharmacovigilance technicians) is published, indicating a structured PV-officer training programme.
[GAP] Specific ADR reporting timelines (e.g. 15 calendar days for serious / 90 days for non-serious), PSUR/PBRER cadence, RMP requirements at AIM, and recall / appeal procedures not extracted in this pass -- they live inside the Manual de Boas Práticas de Farmacovigilância para Titulares de AIM and the operational PV manuals.

SECTION 6: KEY TIMELINES [OFFICIAL -- Circular n.º 15/2025 ANARME DVIL on Cronograma de Tramitação dos Processos de Importação e Libertação; multiple cancellation / authorisation lists dated 2024-2026]

[OFFICIAL -- Lista de Produtos de Saúde Autorizados, dated 29 April 2026, ANARME portal /listas/] Published authorisation list dated 29 April 2026 (most recent reviewed); cancellation list "Lista de Produtos de Saúde Cancelados" published periodically. The presence of regular dated lists indicates active AIM portfolio management.
[OFFICIAL -- Lista de Medicamentos Renovados aos 24 de Abril de 2025, ANARME portal /listas/] Published renewal list dated 24 April 2025 indicates a batched renewal pipeline.

[GAP] Headline full AIM-grant timelines per pathway (Completo / Abreviado / Reconhecimento) are not numerically published in the materials reviewed in this pass.

[FIELD -- anarme.gov.mz/autorizacao-de-entrada-no-mercado-aim/ accessed 2026-05-30] ANARME states a 21-day target for communicating the deferment or refusal of an AIM application following receipt: "O deferimento ou indeferimento do pedido será sempre comunicado ao requerente no prazo máximo de 21 dias posteriores à recepção" (the decision will always be communicated within at most 21 days following receipt). This appears to be the receipt-and-validation triage timeline rather than full scientific assessment.

[FIELD -- Frontiers in Medicine "Pharmaceutical Industry Evaluation of the Effectiveness and Efficiency of the ZAZIBONA Collaborative Medicines Registration Initiative" (2022) and Heads of Medicines Regulatory Authorities ZAZIBONA commitment, accessed 2026-05-30] For the Processo Colaborativo / ZAZIBONA pathway specifically: heads of regulatory authorities including Mozambique have committed to finalising applications within 90 calendar days of submission for products receiving a positive ZAZIBONA recommendation. Mozambique was identified as a member with a 90-day verification target for ZAZIBONA-recommended products. As of December 2021, 333 ZAZIBONA dossiers had been assessed across the nine member NRAs with a median time-to-recommendation of approximately 12 months.

GUIDELINE INDEX
The following ANARME documents have been inventoried from the portal and are the primary references for this KB. Document numbering follows the ANARME convention ANARME.<AREA>.<UNIT> V.<x> v.<y>.

Statutes and regulations:
- Lei n.º 12/2017 de 8 de Setembro -- Law on Medicines, Vaccines and Other Biological Products for Human Use (Boletim da República I Série No. 141, 8 September 2017). Revokes Lei n.º 4/98.
- Decreto n.º 93/2018 de 31 de Dezembro -- Regulation on Authorisation of Introduction in the Market of Medicines, Vaccines and Other Biological Products for Human Use.
- Decreto n.º 19/2023 de 02 de Maio -- Regulation on Authorisation of Introduction in the Market of Health Products and Phytotherapeutic and Homeopathic Medicines (covers devices, IVDs, phytotherapeutic, homeopathic).
- Diploma Ministerial n.º 15/2023 de 20 de Janeiro -- Fee Table for Services Provided by ANARME, I.P. (Tabela de Taxas), Boletim da República I Série No. 14. Revokes Diploma Ministerial n.º 125/2008.

Procedural manuals (ANARME.MAM.DVAM V.001 v.00 2024):
- Protocolo de Recepção e Validação de um Processo de Pedido de AIM Completo no Formato CTD.
- Protocolo de Recepção e Validação de um Processo de Pedido de AIM Abreviado no Formato CTD.
- Protocolo de Recepção e Validação de um Processo de Pedido de AIM por Reconhecimento ou Colaborativo no Formato CTD.
- Protocolo de Recepção e Validação de um Processo de Pedido de Renovação de AIM no Formato CTD.

CTD format references:
- ANARME Formato CTD (national publication).
- SADC Annex IV -- SADC CTD format v02 August 2014 (Portuguese translation published by ANARME).
- SADC Annex III -- SADC Application Form v02 August 2014 (Portuguese translation published by ANARME).

Medical devices:
- Lista Prioritária de Dispositivos Médicos (DM) e Dispositivos Médicos de Diagnóstico In-Vitro (DIVs) Sujeitos ao Registo, ANARME Versão 00, Agosto 2025.
- Lista de Verificação de um Processo de Pedido de AIM de Dispositivo Médico e DIVs pelo Procedimento Colaborativo.
- Lista de Verificação de um Processo de Pedido de AIM de Dispositivo Médico de Diagnóstico in vitro.
- Lista de Verificação de um Processo de Renovação do AIM do Dispositivo Médico e DIV.
- Formulário de Pedidos de Notificação para AIM de DM e DIVs.

Clinical trials:
- Manual de Notificação de Ensaios Clínicos (ANARME).
- Checklist para a Realização de Ensaios Clínicos.

Pharmacovigilance:
- Manual de Boas Práticas de Farmacovigilância (ANARME internal GVP).
- Manual de Boas Práticas de Farmacovigilância para Titulares de AIM (GVP for AIM holders).
- Folheto -- Centro Nacional de Farmacovigilância (public information sheet).
- Guião sobre os requisitos, competências e necessidades de treinamento dos técnicos de farmacovigilância.
- Boletim de Farmacovigilância (semestral and annual editions 2022-2025).
- Boletim Medicamento Seguro (Expo Saúde editions; "Edição 2 anual 2025"; special editions).

Reliance / regional:
- Circular n.º 07/2025 ANARME -- Reconhecimento da Farmacopeia Indiana (recognition of Indian Pharmacopoeia for quality testing).
- WHO TRS 1019 Annex 6 (also published by ANARME in the portal, indicating WHO standards are applied).
- SADC Directriz de Bioequivalência (SADC bioequivalence guideline, also published by ANARME).

Import / export and inspection:
- Circular n.º 15/2025 ANARME DVIL -- Cronograma de Tramitação dos Processos de Importação e Libertação de Produtos.
- Anexo VI -- Formulário para Importação Especial ANARME.
- Formulário de Pedido de Importação Especial.
- Manual de Requisitos e Procedimentos para Autorização de Importação, Exportação e Libertação de Produtos Farmacêuticos (referenced; fetch-failed during scrape).
- Lista de Inspectores DRN / DRC / DRS / Sede e DRS (regional inspector rosters).

Establishment / good practices:
- Manual de Boas Práticas Regulamentares.
- Manual de Boas Práticas de Farmácia Comunitária e Hospitalar.
- Minuta para o Requerimento de Instalação de Empresa de Importação, Distribuição e Transportadoras.

Strategic / governance:
- Plano Estratégico da ANARME.IP.
- Plano Estratégico de Comunicação da ANARME.IP.
- Política de Qualidade da ANARME.IP.
- Manual da Qualidade da ANARME.IP.
- Organograma da ANARME.IP.
- Despacho Ministerial de 23 de Janeiro de 2017 -- Reestauração do Programa de Medicina Desportiva.

Source: https://anarme.gov.mz (manuais, guiões e directrizes; modelos e formulários; boletins; circulares; listas; legislação nacional)

==============================================================
SHAAMI MALAWI REGULATORY KNOWLEDGE BASE -- PMRA
Regulator: Pharmacy and Medicines Regulatory Authority (PMRA)
Legal basis: [OFFICIAL -- Pharmacy and Medicines Regulatory Authority Act, 2019 (Act No. 9 of 2019), Malawi Gazette Supplement No. 3C dated 22 February 2019, assented 19 February 2019]
Address: Pharmacy and Medicines Regulatory Authority, Malawi (operational headquarters in Lilongwe; regulatory inspectorate covers Blantyre, Lilongwe, Mzuzu)
Website: https://www.pmra.mw
Portal: PMRA operates a WordPress-based document portal at www.pmra.mw with sections /marketing-authorisation-of-medicines/, /guidelines/, /fee-schedule/, /applications-forms/, /premises-register/, /personnel-licensing/, /import-and-export-permits/, /adverse-events-monitoring/, /vetting-of-advertising-materials/, /business-premises-licensing/, /the-act/.
NRA maturity: [OFFICIAL -- PMRA Strategic Plan 2024-2028 (web version, 21 May 2024)] PMRA has an Institutional Development Plan (IDP) and a roadmap towards achieving WHO Maturity Level II and Maturity Level III. PMRA is not yet on the published African NRA ML3 list. [FIELD -- WHO benchmarking summary January 2025] the eight ML3 African NRAs are Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Zimbabwe -- Malawi (PMRA) is not yet included.
Regional memberships: SADC member; ZAZIBONA active member [OFFICIAL -- Registration Procedure for Medicines Recommended for Registration by ZAZIBONA, PMRA; PMRA Strategic Plan 2024-2028]. ZAZIBONA collaborates between Zambia, Zimbabwe, Botswana, Namibia, South Africa and other SADC NRAs including Malawi.
Sources: PMRA Act No. 9 of 2019; PMRA (Fees and Forms) (Amendment) Regulations 2026 (Government Notice No. 27 of 2026, Malawi Gazette Supplement No. 8A dated 27 March 2026, effective 1 April 2026) amending G.N. No. 9 of 2022; PMRA CTD Format Guidelines; Guidance on Post Approval Changes (Variations) PMRA-GD-REG-MA-03.00 effective 12 September 2024; Guidance for Registration of Fast Track Products PMRA-GD-REG-MA-002-00 effective May 2023; Guidance on Waiver of In Vivo Bioequivalence Requirements PMRA-GD-REG-003-01 effective August 2025; Guidance on Importation and Exportation PMRA-GD-REG-005-01 effective November 2023; Guidance on Advertisement of Medicines and Allied Substances; Guidelines for Drug Donations; Guidelines for Pharmacy Personnel Registration; Product Information Guidelines; Minimum Requirements documents for Manufacturing, Wholesale, Retail, Dispensing, Medicine Store, Medical Device Wholesaler, Veterinary Medicine Store; Registration Procedure for Medicines Recommended by ZAZIBONA; PMRA Strategic Plan 2024-2028; ZAZIBONA shared documents
Last updated: 2026-05-30
==============================================================

REGULATOR AND PORTALS
PMRA (Pharmacy and Medicines Regulatory Authority) is the national medicines regulatory authority of Malawi, established by the Pharmacy and Medicines Regulatory Authority Act 2019 (Act No. 9 of 2019). PMRA is responsible for personnel licensing (pharmacists, technologists/technicians, assistants, medical representatives), premises licensing (manufacturer, wholesale, retail, medicine store, dispensing, medical device wholesaler, veterinary), product registration (human medicines, veterinary medicines, medical devices, cosmetics, nutritional supplements, traditional medicines, disinfectants, reagents, feed additives), GMP inspection, import/export permits, clinical trial authorisation, pharmacovigilance, advertising vetting, and quality control laboratory testing.
PMRA portal sections at www.pmra.mw include /marketing-authorisation-of-medicines/ (MA application landing), /guidelines/ (guidance documents), /fee-schedule/ (current and historical fee structures), /applications-forms/, /premises-register/, /personnel-licensing/, /import-and-export-permits/, /adverse-events-monitoring/, /vetting-of-advertising-materials/, /business-premises-licensing/, /the-act/.
Currency: All fees are dual-denominated. Fees for Malawi-manufactured or Malawi-citizen activities are denominated in Malawi Kwacha (K / MWK). Fees for foreign manufacturers, non-Malawian persons or activities outside Malawi are denominated in US Dollar (USD). The fee schedule explicitly publishes both tiers side by side.
Registration certificate validity: [GAP] Specific validity period not extracted in this pass; the existence of an annual retention-fee schedule (Section 6 of the Fees Regulations) and explicit renewal/re-registration fees (Section 5) confirms a finite validity with periodic renewal.

LOCAL REPRESENTATIVE
A Malawian-licensed pharmaceutical entity is required to file applications. The fee schedule explicitly distinguishes "medicine manufactured in Malawi" (paid in Kwacha) from "medicine manufactured outside Malawi" (paid in USD) -- the foreign-manufacturer category presupposes a local applicant. Premises licensing (wholesale pharmacy, retail pharmacy, medicine store, dispensing licence, medical device licence) is a separate licensing chain held by the Malawian entity.
A Malawian Medical Representative licence is required for product promotion: registration K 500,000 (Malawian) / USD 1,500 (non-Malawian); retention K 300,000 / USD 750. [OFFICIAL -- PMRA (Fees and Forms) (Amendment) Regulations 2026, First Schedule Section 1(d) and 2(d)]
[GAP] Specific qualifications, ongoing obligations, and exclusive-distribution requirements for the local representative role not extracted from the materials reviewed in this pass.

SECTION 1: MEDICINES (HUMAN)

1.1 Registration pathways
PMRA operates five distinct registration pathways for human medicines, each with a published calendar-day target. [OFFICIAL -- PMRA Marketing Authorisation of Medicines portal pmra.mw/marketing-authorisation-of-medicines/]

a) Normal (full) registration -- full review of quality and clinical information. **Target: 360 calendar days.**
b) WHO Collaborative Registration Procedure (WHO CRP) -- applies to WHO-Prequalified products. **Target: 90 calendar days from PMRA access to the WHO assessment reports.**
c) SRA-registered products -- reliance on Stringent Regulatory Authority approvals. **Target: 90 calendar days from complete dossier submission.** Requires assessment report from the reference authority.
d) ZAZIBONA-recommended medicines -- products recommended for registration by the ZAZIBONA Central Office. Applicants must submit to PMRA within one year of the recommendation. **Target: 90 calendar days regulatory period.** [OFFICIAL -- PMRA Registration Procedure for Medicines Recommended for Registration by ZAZIBONA]
e) Public health priority diseases -- non-prequalified products treating priority conditions (ARVs, anti-malarials, TB, reproductive health, neglected diseases). **Target: 180 calendar days.** [OFFICIAL -- PMRA-GD-REG-MA-002-00, Fast Track Guidance, effective May 2023]

Additionally, BCS biowaivers allow waiver of in vivo bioequivalence requirements for immediate-release solid oral dosage forms eligible under the Biopharmaceutics Classification System. [OFFICIAL -- PMRA-GD-REG-003-01, Guidance on Waiver of In Vivo Bioequivalence Requirements, effective August 2025]

1.2 Recognised reference authorities and reliance [OFFICIAL -- PMRA-GD-REG-MA-002-00 Fast Track Guidance]
For the fast-track pathway, PMRA expressly accepts:
- WHO Prequalified Products (WHO/PQP).
- Public-health programme products in defined therapeutic areas (ARVs, Anti-Malaria, TB, Reproductive Health, neglected diseases).
- Products registered by countries within the ICH region.

[FIELD -- PMRA Marketing Authorisation page; PMRA-GD-REG-005-01 Importation Guidance] PMRA's reliance / GMP recognition framework accepts manufacturing sites GMP-certified by PMRA itself, PIC/S members, any SRA, or holding WHO GMP certification. For product approval, PMRA recognises products authorised by USFDA, EMA, any SRA-country, or WHO PQ. The ICH-region fast-track route in PMRA-GD-REG-MA-002-00 is a separate reliance category.

[GAP] The full enumerated list of "SRA" countries accepted by PMRA is in PMRA-GD-REG-MA-002-00 section 4.3 and the Importation Guidance; the canonical SRA list is the WHO-published one and PMRA materially aligns to it -- but the precise PMRA list was not exhaustively extracted in this pass.

1.3 Fees -- medicines [OFFICIAL -- PMRA (Fees and Forms) (Amendment) Regulations 2026, Government Notice No. 27 of 2026, Malawi Gazette Supplement No. 8A dated 27 March 2026, effective 1 April 2026, made under section 129 of the PMRA Act 2019, amending G.N. No. 9 of 2022 First Schedule]

All fees are denominated in MWK (K) for Malawian / locally-manufactured activities and in USD for non-Malawian / outside-Malawi activities. Section numbers refer to the First Schedule of the 2026 Regulations.

Section 5(a) -- Human medicine registration:
- Generic medicine manufactured in Malawi: K 800,000
- Line extension of generic in Malawi: K 500,000
- Generic medicine manufactured outside Malawi: USD 1,700
- Line extension of generic outside Malawi: USD 1,000
- New chemical entity (NCE), including dosage form or delivery system, manufactured outside Malawi: USD 2,200
- Biologicals manufactured outside Malawi: USD 2,000
- Renewal / re-registration in Malawi: K 500,000
- Renewal / re-registration outside Malawi: USD 1,000
- Orphan medicine manufactured outside Malawi: USD 500
- Administration fee for issuance of Certificate of Pharmaceutical Product (CPP): K 100,000

Section 5(b) -- Veterinary medicine registration:
- Generic in Malawi: K 600,000; outside: USD 1,200
- Line extension in Malawi: K 400,000; outside: USD 750
- NCE outside Malawi: USD 1,700
- Biologicals outside Malawi: USD 1,500
- Renewal in Malawi: K 400,000; outside: USD 750

Section 6 -- Annual retention fees for medicinal products:
- Human medicine manufactured in Malawi: K 500,000
- Human medicine manufactured outside Malawi: USD 700
- Orphan medicine: USD 300
- Veterinary medicine in Malawi: K 300,000; outside: USD 600

Section 7(g) -- Fast-track registration of medicines or allied substances manufactured outside Malawi: twice the normal rate of the corresponding Section 5 or 7 fee.

1.4 GMP requirements and inspection fees [OFFICIAL -- PMRA (Fees and Forms) (Amendment) Regulations 2026, First Schedule Section 3(a) and 3(b)]

GMP inspection of Malawian manufacturers (Section 3(a)):
- Oral dosage forms, general (solids and liquids): K 3,500,000
- Oral dosage forms, beta-lactam and cephalosporins (solids and liquids): K 3,500,000
- External preparation: K 2,500,000
- Sterile preparations, general (solids and liquids): K 4,000,000
- Sterile preparations, beta-lactam and cephalosporins: K 4,000,000
- Hormones, general oral solids: K 3,500,000
- Hormones, sterile: K 4,000,000
- Primary and secondary packaging: K 3,500,000
- Medical oxygen gas: K 3,000,000
- Re-inspection (previously failed, follow-up or investigation): cost of travel

GMP inspection of non-Malawian (foreign) manufacturers (Section 3(b)) -- by site:
- Manufacturing within SADC: USD 4,000
- Rest of Africa: USD 5,500
- Outside Africa: USD 6,500
- Additional category for GMP: USD 2,000
- Desk review per manufacturing plant: USD 3,500
- Desk review, additional category for GMP: USD 1,000

Section 4(a) -- Annual retention fees for manufacturing premises:
- Oral dosage forms (solids/liquids): K 500,000
- External preparations: K 300,000
- Sterile preparations: K 500,000
- Primary packaging only: K 300,000
- Secondary packaging only: K 200,000

[FIELD] The desk-review option at USD 3,500 explicitly anticipates reliance on a recent GMP inspection from a recognised authority (an SRA or PIC/S equivalent) -- the desk fee is roughly half the on-site inspection fee for sites outside Africa, signalling a clear reliance discount for foreign-GMP-certified manufacturers.
[GAP] The specific list of foreign GMP certificates (SRA, PIC/S, WHO PQ, WHO TRS) accepted for desk-review reliance is not extracted in this pass.

1.5 Renewal of registration [OFFICIAL -- Fees Regulations 2026, First Schedule Section 5(a)(vii)-(viii) and Section 6]
Renewal / re-registration fees: K 500,000 in Malawi / USD 1,000 outside Malawi for human medicines; K 400,000 / USD 750 for veterinary medicines. Annual retention fees of K 500,000 / USD 700 (human) and K 300,000 / USD 600 (veterinary) apply between renewals.
[GAP] AIM validity period and renewal lead-time are not in the Fees Regulations; to be confirmed from the dedicated PMRA Renewal guidance (not fetched in this pass).

1.6 Variations and post-approval changes [OFFICIAL -- PMRA-GD-REG-MA-03.00, Guidance on Post Approval Changes (Variations), effective 12 September 2024; Fees Regulations 2026 First Schedule Section 9]

Variation classification: notifications, minor variations, major variations.
Fees:
- Notification for product manufactured in Malawi: K 100,000; outside: USD 150
- Minor variation in Malawi: K 150,000; outside: USD 200
- Major variation in Malawi: K 250,000; outside: USD 500

A major change made post-ZAZIBONA recommendation disqualifies the application from the ZAZIBONA pathway (a returning standard or fast-track pathway is then required). [OFFICIAL -- PMRA Registration Procedure for ZAZIBONA, item 7]

1.7 Import / export and authorised ports [OFFICIAL -- PMRA-GD-REG-005-01, Guidance on Importation and Exportation of Medicinal Products and Active Pharmaceutical Ingredients, effective November 2023; Fees Regulations 2026 First Schedule Section 10]

Import/export permit fees:
- Import or export permit for registered medicines, per consignment: 1.5% of invoice value (including freight and insurance)
- Verification fees for commercial consignments and donations to commercial organisations: 1% of invoice value
- Importation of unregistered medicines or allied substances from authorised sources: 7% of invoice value (significant premium that disincentivises pre-registration importing)
- Verification of donations to non-profit charitable NGOs: K 50,000
- Narcotics permit: K 100,000
- Amendment of import permit: K 200,000
- Amendment of narcotics permit: K 50,000
- Import or export permit for Investigational Medicinal Product (IMP): K 100,000
- Amendment of IMP import/export permit: K 50,000

Disasters, outbreak, and raw materials are exempted from verification/approval fees for donations.

Specific guidance documents on Donation Import Permit and Inspection at Ports of Entry / In-Land Depot are published in the same Guidance (PMRA-GD-REG-005-01).

1.8 Site Master File
[GAP] SMF requirements are not extracted from the CTD Format Guidelines body in this pass; ICH/WHO TRS 961 Annex 14 is the global standard and PMRA applies CTD Module 3.2.A.1 by convention.

1.9 Establishment / manufacturer / wholesaler / importer / pharmacy licensing [OFFICIAL -- Fees Regulations 2026 First Schedule Section 3(c)-(g) and Section 4]
PMRA licences a tiered set of pharmaceutical premises types. Each requires inspection and processing at the fees below.

Section 3 -- Inspection and processing of new premises:
- Wholesale pharmacy licence: K 2,000,000
- Retail pharmacy licence: K 1,500,000
- Medicine store licence or veterinary shop licence: K 500,000
- Dispensing licence private facility with admission service: K 1,200,000
- Dispensing licence private facility without admission service: K 350,000
- Dispensing licence public facility / CHAM (Christian Health Association of Malawi) facility with admission service: K 500,000
- Dispensing licence institutional facility: K 1,000,000
- Dispensing licence health centre: K 385,000
- Medical device licence: K 1,500,000

Section 4 -- Annual retention fees for premises:
- Wholesale pharmacy: K 1,000,000; relocation/alterations: K 1,000,000
- Retail pharmacy: K 500,000; relocation/alterations: K 750,000
- Medicine store / veterinary shop: K 200,000; relocation: K 300,000
- Dispensing with admission: K 600,000; without admission: K 200,000
- Institutional dispensing: K 600,000
- Medical device: K 750,000; relocation/alterations: K 800,000

[OFFICIAL -- Minimum Requirements documents published by PMRA for each premises type: Dispensing Premises, Medical Device Wholesaler, Medicine Store, Retail Pharmacy, Wholesale Pharmacy, Veterinary Medicine Store] The minimum-requirements suite specifies floor area, staffing, storage conditions, cold-chain capability, fire safety, and record-keeping requirements per premises class. Foreign manufacturers do not register directly in Malawi; their products are registered to and held by a Malawian-licensed importer/distributor.

SECTION 2: MEDICAL DEVICES AND IVDs [OFFICIAL -- Fees Regulations 2026 First Schedule Section 7(a) and Section 8(a)]

Medical devices are regulated under the "allied substances" framework of the PMRA Act 2019 alongside cosmetics, nutritional supplements, traditional medicines, disinfectants/reagents, and feed additives. The fee schedule expressly publishes a three-class device tier: Class I, Class II, Class III (no Class IV in the published schedule). A separate Medical Device Wholesaler premises licence and minimum-requirements document apply for distribution.

Registration fees -- medical devices (Section 7(a)):
- Class I manufactured in Malawi: K 150,000
- Class I manufactured outside Malawi: USD 700
- Class II in Malawi: K 500,000; outside: USD 1,000
- Class III in Malawi: K 1,000,000; outside: USD 1,700
- Renewal / re-registration Class I in: K 100,000; outside: USD 500
- Renewal Class II in: K 300,000; outside: USD 700
- Renewal Class III in: K 800,000; outside: USD 1,000
- Fast-track registration: twice the normal rate

Retention fees -- medical devices (Section 8(a)):
- Class I in: K 100,000; outside: USD 300
- Class II in: K 200,000; outside: USD 400
- Class III in: K 500,000; outside: USD 1,000

Premises:
- Medical device licence (inspection and processing): K 1,500,000
- Annual retention: K 750,000

[OFFICIAL -- PMRA Medical Device Register (published portal /premises-register/)] PMRA maintains a public register of medical-device suppliers with PMRA/MD/<sequence> registration numbers starting from PMRA/MD/01 (registered 19 September 2014). The register publishes the supplier name, address, district, and registration date.

[GAP] The published Fees Regulations stop at Class III; an explicit Class IV tier is not in the fee schedule. The PMRA medical-device classification rules and conformity assessment requirements (ISO 13485 mandation, CE/FDA recognition policy, SaMD framework) are not extracted in this pass.

SECTION 3: COMPLEMENTARY / HERBAL / SUPPLEMENTS [OFFICIAL -- Fees Regulations 2026 First Schedule Section 7(b)-(d) and Section 8(b)-(d)]

PMRA regulates three product categories adjacent to medicines under the allied-substances framework: cosmetics, nutritional supplements, and traditional medicines. Each has its own registration and retention fee tier.

Cosmetics (Section 7(b)):
- Registration in Malawi: K 300,000; outside: USD 700
- Renewal in: K 150,000; outside: USD 500
- Retention in: K 100,000; outside: USD 500

Nutritional supplements (Section 7(c)):
- Registration in: K 200,000; outside: USD 700
- Renewal in: K 150,000; outside: USD 400
- Retention in: K 100,000; outside: USD 500

Traditional medicines (Section 7(d)):
- Registration in: K 200,000; outside: USD 700
- Renewal in: K 150,000; outside: USD 400
- Retention in: K 100,000; outside: USD 500

[GAP] Specific quality, safety and labelling requirements for these categories, and the GMP standard applied, are not extracted in this pass.

SECTION 3B: BIOLOGICALS / VACCINES [OFFICIAL -- Fees Regulations 2026 First Schedule Section 5(a)(vi) and 5(b)(vi); PMRA Press Release "Malawi registers Lenacapavir for HIV-1 prevention"]

Biologicals are regulated within the human-medicines framework with a distinct registration fee:
- Biologicals manufactured outside Malawi: USD 2,000 (human); USD 1,500 (veterinary)

[OFFICIAL -- Press Release: Malawi Registers Lenacapavir for HIV-1 Prevention] PMRA has registered Lenacapavir (a long-acting injectable HIV-1 prevention biologic). This is a recent regulatory milestone and signals active biological-product processing capacity.

[GAP] Lot release procedures, RMP requirements, PMF/VAMF acceptance, biosimilar pathway specifics, and cold-chain assurance protocol are not extracted in this pass.

SECTION 4: CLINICAL TRIALS [OFFICIAL -- Fees Regulations 2026 First Schedule Section 12]

Clinical trial application fees by phase:
- Phase I: USD 9,000
- Phase II: USD 6,000
- Phase III: USD 5,000
- Academic research clinical trial: USD 2,000
- Fast-track clinical trial application: twice the normal rate

Clinical trial amendments:
- Major amendment: USD 300
- Minor amendment: USD 100
- Renewal of clinical trial: USD 2,200

[OFFICIAL -- Fees Regulations 2026 Section 10(i)-(j)] Import or export permit for Investigational Medicinal Product (IMP): K 100,000; amendment K 50,000.

[GAP] Ethics-committee approval pathway, GCP standard applied, investigator residency requirements, liability insurance, sponsor/CRO obligations, and the CT review timeline are not extracted in this pass.

SECTION 5: POST-MARKET / PHARMACOVIGILANCE [OFFICIAL -- PMRA portal /adverse-events-monitoring/; ADR Reporting Form and AEFI Reporting Form published]

PMRA operates an Adverse Events Monitoring function. ADR Reporting Form and AEFI (Adverse Event Following Immunisation) Reporting Form are published on the PMRA portal under /adverse-events-monitoring/.

[OFFICIAL -- Guidance on Advertisement of Medicines and Allied Substances] Pharmaceutical promotional material requires PMRA vetting in advance of dissemination. Fee schedule Section 13 details vetting fees per format (written K 80,000 / USD 150; audio/video K 150,000 / USD 150; posters/billboards K 100,000 / USD 150; vehicle posters K 80,000 / USD 150; t-shirts K 50,000 / USD 150; other materials K 50,000 / USD 150). The Authority has issued public notices on regulatory enforcement action against non-compliant pharmaceutical premises and personnel.

[GAP] Specific ADR reporting timelines (e.g. 15 calendar days for serious / 90 days for non-serious), PSUR/PBRER cadence, RMP requirements at registration, and recall procedures not extracted in this pass.

SECTION 6: KEY TIMELINES [OFFICIAL -- PMRA Marketing Authorisation of Medicines portal (pmra.mw/marketing-authorisation-of-medicines/); PMRA Registration Procedure for Medicines Recommended for Registration by ZAZIBONA; PMRA-GD-REG-MA-002-00 Fast Track Guidance]

PMRA publishes pathway-specific calendar-day targets:

| Pathway | Target | Eligible products |
|---|---|---|
| Normal full registration | 360 calendar days | Default for products outside reliance/work-sharing |
| WHO Collaborative Registration Procedure (CRP) | 90 days from PMRA access to WHO reports | WHO-Prequalified products |
| SRA-registered product reliance | 90 days from complete dossier submission | Products with an SRA approval and assessment report |
| ZAZIBONA-recommended | 90 days regulatory period | Products recommended by ZAZIBONA Central Office; submission within 1 year of recommendation |
| Public health priority diseases | 180 days | Non-prequalified ARVs, anti-malarials, TB, RH, neglected disease products |

The 4x speed-up between Normal (360 d) and reliance pathways (90 d) is a clear, published incentive for foreign manufacturers to use the SRA / WHO CRP / ZAZIBONA routes where eligible. Fast-track fees (Section 7(g) of the 2026 Fees Regulations) apply at "twice the normal rate" of the corresponding registration fee.

[FIELD -- WHO benchmarking summary January 2025 + PMRA Strategic Plan 2024-2028] WHO conducted a Global Benchmarking Tool (GBT) assessment of PMRA in March 2023. The published outcome confirms PMRA has documented procedures for medicines import/distribution authorisation that are well implemented and a rapid alert system for substandard/falsified products. The Strategic Plan publishes an Institutional Development Plan (IDP) and a roadmap towards WHO ML II and ML III; PMRA is not yet on the WHO ML3 list (the eight African ML3 NRAs as of January 2025 are EG, GH, NG, RW, SN, ZA, TZ, ZW).

GUIDELINE INDEX
The following PMRA documents have been inventoried from the official portal and form the primary references for this KB. Document numbers follow PMRA convention PMRA-GD-<unit>-<area>-<seq>-<version>.

Statutes and regulations:
- Pharmacy and Medicines Regulatory Authority Act, 2019 (Act No. 9 of 2019) -- Malawi Gazette Supplement No. 3C, 22 February 2019.
- Malawi Access to Information Act, February 2017 (also republished on PMRA portal for ATI compliance).
- Pharmacy and Medicines Regulatory Authority (Fees and Forms) (Amendment) Regulations, 2026 -- Government Notice No. 27 of 2026, Malawi Gazette Supplement No. 8A, 27 March 2026, effective 1 April 2026. Amends G.N. No. 9 of 2022 First Schedule.

Procedural guidance:
- Pharmacy and Medicines Regulatory Authority Common Technical Document Format Guidelines -- PMRA CTD format.
- Guidance for the Registration of Human Medicinal Products Classified for Fast Track Process -- PMRA-GD-REG-MA-002-00, effective May 2023.
- Guidance on Post Approval Changes (Variations) -- PMRA-GD-REG-MA-03.00, effective 12 September 2024.
- Guidance on Waiver of In Vivo Bioequivalence Requirements for Immediate-Release Solid Oral Dosage Forms -- PMRA-GD-REG-003-01, effective August 2025.
- Guidance on Importation and Exportation of Medicinal Products and Active Pharmaceutical Ingredients -- PMRA-GD-REG-005-01, effective November 2023.
- Guidance on Advertisement of Medicines and Allied Substances.
- Guidelines for Drug Donations.
- Guidelines For Pharmacy Personnel Registration.
- Product Information Guidelines.
- Registration Procedure for Medicines Recommended for Registration by ZAZIBONA -- PMRA.

Premises -- Minimum Requirements documents:
- Minimum Requirements for Dispensing Premises.
- Minimum Requirements for Medical Device Wholesaler.
- Minimum Requirements for Medicine Store.
- Minimum Requirements for Retail Pharmacy.
- Minimum Requirements for Wholesale Pharmacy.
- Minimum requirements for a Veterinary Medicine Store.

Application forms portfolio (representative subset):
- Application Form for Medicine Store; Wholesale Pharmacy; Retail Pharmacy; Dispensing Licence; Medical Device Wholesaler; Veterinary Shop Licence; Medicine Store Re-location; Retail Pharmacy Re-location; Wholesale Pharmacy Re-location.
- Application Form for Upgrading Medicine Store to Retail Pharmacy; Application Form for Downgrading Retail Pharmacy to Medicine Store.
- Pharmacy Personnel Application Form; Application for a Practicing Licence and Retention of Name on Register (Personnel); Application Form for Resit of Pharmacy Personnel Registration Examination.
- Application Form for Advertising Material.

Strategic / governance:
- PMRA Strategic Plan 2024-2028 (web version, 21 May 2024).
- PMRA Information Pack.
- PMRA Access to Information (ATI) Manual.

Public registers:
- Medical Device Register (PMRA/MD/<number>); Dispensing Licence Register; Retail Pharmacy Register; Wholesale Pharmacy Register.
- Premises register and personnel register sections of the public portal.

Source: https://www.pmra.mw (Guidelines; Marketing Authorisation of Medicines; Fee Schedule; Applications & Forms; Premises Register; Personnel Licensing; The Act)

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SHAAMI ANGOLA REGULATORY KNOWLEDGE BASE -- ARMED
Regulator: Agência Reguladora de Medicamentos e Tecnologias de Saúde (ARMED) -- the official name confirmed by the ARMED public website meta description and by the founding Decree. NOTE: ARMED's name expands to "Medicamentos e Tecnologias de Saúde" (Medicines and Health Technologies) -- not "Dispositivos Médicos" (Medical Devices) as is sometimes incorrectly cited externally.
Legal basis: [OFFICIAL -- Decreto Presidencial n.º 136/21 de 1 de Junho, Diário da República I Série n.º 100 (1 June 2021), creates ARMED and approves its Organic Statute; revokes pharmaceutical-aspect provisions of the Ministry of Health Organic Statute (Decreto Presidencial n.º 277/20) and Article 9 nº 4 of the older Regulamento de Exercício da Actividade Farmacêutica (Decreto Presidencial n.º 191/10)] [OFFICIAL -- Decreto Presidencial n.º 315/20 de 17 de Dezembro, Diário da República I Série n.º 204 (17 December 2020), approves the Regulamento do Registo de Medicamentos -- Medicines Registration Regulation] [OFFICIAL -- Decreto Presidencial n.º 253/21 de 14 de Outubro, Diário da República I Série n.º 195 (14 October 2021), establishes the Regulamento sobre a Farmacovigilância -- Pharmacovigilance Regulation] [OFFICIAL -- Decreto Presidencial n.º 41/24 de 29 de Janeiro, Diário da República I Série n.º 20 (29 January 2024), approves the Regulamento sobre o Licenciamento para o Exercício da Actividade Farmacêutica -- the current Pharmaceutical Activity Licensing Regulation; revokes articles 8, 9, 10, 11, 13, 47, 49 of Decreto Presidencial n.º 191/10 plus Decreto Presidencial n.º 202/21 in its entirety] [OFFICIAL -- Decreto Presidencial n.º 180/10 de 18 de Agosto, establishes the Bases Gerais da Política Nacional de Medicamentos] [OFFICIAL -- Decreto Executivo Conjunto MINFIN e MINSA n.º 1/25 de 14 de Janeiro, fees regulation; source for the published taxas e emolumentos]
Address: Luanda, Angola (registered office at the Ministério da Saúde / ARMED headquarters; specific street address to be confirmed)
Website: https://www.armed.gov.ao -- React single-page application backed by a public REST API at armed-production-server.up.railway.app. Documents and Diários da República are linked from each menu section under /informacoes?menu=...&tipoFile=...
Portal: ARMED publishes circular/decreto/despacho/lei suites at https://www.armed.gov.ao via the public site. The taxas-e-emolumentos page is the canonical fee landing.
NRA maturity: [FIELD -- WHO Regional Office for Africa news, June 2025, accessed 2026-05-31; ARMED-EDA Memorando de Entendimento Artigo 2.º a); APAnews "Angola aims for pharma regulatory maturity by 2027"] ARMED is targeting **WHO Maturity Level 3 by 2027**. The IDP (Institutional Development Plan) was updated in June 2025 at a 25-professional ARMED strategic meeting with WHO technical support and EU funding, building on the 2022 and February 2024 WHO GBT self-assessments. EDA (Egypt) provides parallel bilateral technical support toward the same ML3 goal. ARMED is currently NOT on the published African NRA ML3 list (which as of January 2025 names EG, GH, NG, RW, SN, ZA, TZ, ZW).
Regional memberships: SADC member. **[FIELD -- multiple SADC-MRH publications including PMC ZAZIBONA evaluation studies and Frontiers in Medicine 2022, accessed 2026-05-31]** Angola participates in **ZAZIBONA as a NON-ACTIVE (observer) member** -- distinct from the nine ACTIVE NRAs (BW, DRC, MW, MZ, NA, SA, TZ, ZM, ZW) that contribute to joint assessments and inspections. The observer status means Angola does not currently participate in ZAZIBONA work-shared assessments but is part of the broader SADC pharmaceutical harmonisation conversation. **For MAA clients: filing in Angola today therefore goes through the standard ARMED national route -- not a ZAZIBONA work-sharing route -- so the ZAZIBONA 90-day reliance route available in MZ/MW/ZA/ZW does NOT yet apply in Angola.** [FIELD -- Visão newspaper and Government of Angola official news, 4 June 2021] ARMED's founding statute (Decreto 136/21) explicitly aligns Angolan pharmaceutical legislation with the **African Union Model Law on Regulation of Pharmaceutical Products (approved January 2016)** -- ARMED is therefore positioned in the AMA (African Medicines Agency) alignment track.
Sources: Decreto Presidencial 136/21 (ARMED creation); Decreto Presidencial 315/20 (registration); Decreto Presidencial 253/21 (pharmacovigilance); Decreto Presidencial 41/24 (licensing); Decreto Presidencial 180/10 (national policy); Decreto Presidencial 191/10 (legacy framework, partially superseded); Decreto Presidencial 161/21 + 182/22 (simplification project); Decreto Executivo Conjunto MINFIN/MINSA 1/25 (fees); ARMED public API /emolumentos endpoint (42 itemised fees); ARMED-EDA Memorando de Entendimento; Lista de Medicamentos Registados em Angola até Fevereiro de 2025; 138 inventory items across 27 Decretos, 29 Despachos, 7 Leis, 66 Circulares, 1 Farmacovigilance bulletin, 8 Outros (manifest at docs/_manifest_angola.json)
Last updated: 2026-05-31
==============================================================

REGULATOR AND PORTALS
ARMED (Agência Reguladora de Medicamentos e Tecnologias de Saúde) was created by Decreto Presidencial n.º 136/21 de 1 de Junho 2021 as the national regulatory authority for medicines and health technologies in Angola. ARMED is under the tutela of the Ministério da Saúde (Ministry of Health, MINSA), with joint financial competence with the Ministério das Finanças (MINFIN) for fee-setting matters (e.g. the Decreto Executivo Conjunto MINFIN/MINSA n.º 1/25 fee regulation).
ARMED's mandate covers: human medicines, traditional medicines, biological products, derivatives of blood and other health products, plus medical devices and other health technologies. Its current Director-General signs Despachos under "DG-ARMED" prefix.
Prior to ARMED, the regulator function lived within MINSA's Direcção Nacional de Medicamentos e Equipamentos (DNME). [FIELD -- novojornal.co.ao 4 June 2021] Decreto Presidencial 136/21 explicitly EXTINGUISHED the DNME and transferred its functions to ARMED. Many older Circulares carry "DNME/MINSA" prefixes and remain in force where not contradicted by post-2021 ARMED issuances; references to DNME in those Circulares should be read as ARMED.
Currency: Kwanza (Kz, AOA). Fees are denominated in AOA and published via the ARMED /emolumentos endpoint and gazetted under Decreto Executivo Conjunto MINFIN/MINSA n.º 1/25 de 14 de Janeiro 2025.
Registration certificate validity: [GAP] Specific AIM certificate validity period not directly extracted in this pass. The fee schedule structures most licences on a 5-year (5 anos) cycle (manufacturing, importer/distributor, pharmacy and laboratory licences are explicitly "5 anos"); annual Inspecção certificates are renewed yearly.

LOCAL REPRESENTATIVE
[OFFICIAL -- ARMED Emolumentos -- "Pedido de licenciamento de Representante (5 anos)" at AOA 100,000] ARMED operates a Representante (Representative) licensing tier. Any foreign manufacturer engaging the Angolan market through a Representante must hold a 5-year ARMED-issued Representante licence.
Importer and distributor licensing is a separate, higher-tier set of licences in their own right:
- Pedido de licenciamento de Importador e distribuidor (5 anos): AOA 2,500,000
- Pedido de licenciamento de Distribuidor (5 anos): AOA 800,000
- Pedido de licenciamento de Importador restrito (empresas petrolíferas e diamantíferas) (5 anos): AOA 800,000
- Pedido de licenciamento de Importador de especialidade (5 anos): AOA 370,000
- Pedido de licenciamento de Importador de produtos percusores para indústria (5 anos): AOA 1,000,000
[FIELD] In practice the foreign manufacturer's local representative for AIM purposes is typically an Angolan-licensed Importador or Importador e distribuidor entity rather than a stand-alone Representante. The Representante tier likely covers individual liaison roles; importer/distributor licences cover the commercial side. Detailed Representante role definition is in the Regulamento sobre o Licenciamento (Decreto Presidencial n.º 41/24) and not exhaustively extracted in this pass.
[GAP] Specific ongoing obligations, qualification requirements, and exclusive-distribution rules for each licence class are in the Regulamento sobre o Licenciamento and not extracted in detail in this pass.

SECTION 1: MEDICINES (HUMAN)

1.1 Registration pathways [OFFICIAL -- Decreto Presidencial n.º 315/20 de 17 de Dezembro 2020 -- Regulamento do Registo de Medicamentos; Decreto Presidencial n.º 161/21 de 21 de Junho approves the "Projecto de Simplificação"; Decreto Presidencial n.º 182/22 de 22 de Julho approves the broader "Processo de Simplificação" governance reforms]
The current registration framework is the Regulamento do Registo de Medicamentos approved by Decreto Presidencial n.º 315/20. ARMED has since 2021 prioritised a "simplificação" reform programme covering pharmaceutical procedures -- Decreto Presidencial n.º 161/21 approved the project, and Decreto Presidencial n.º 182/22 approved the broader process. The combined effect signals an ARMED priority on reducing dossier burden and shortening review times, particularly via reliance.

1.2 Recognised reference authorities and reliance [OFFICIAL -- Memorando de Entendimento entre ARMED e a Autoridade Egípcia de Medicamentos (EDA) sobre Cooperação em Produtos Farmacêuticos, Produtos Biológicos e Dispositivos Médicos]
ARMED's bilateral cooperation framework explicitly establishes a reliance route on the Egyptian Drug Authority. Under the MoU Article 2.º b), the Angolan side commits to:
- Recognise products registered by EDA (with the option for additional ARMED product evaluation if and when considered appropriate);
- Recognise EDA pharmaceutical-inspection procedures and Good Manufacturing Practice certificates.
Under Article 2.º c) EDA supports ARMED with:
- Technical support for installation and operationalisation of the Laboratório Nacional de Controlo da Qualidade (national medicines QC laboratory);
- Training and expert exchange in pharmaceutical management, GMP inspection, GLP, distribution, storage and transport;
- Sharing of verification and certification results for medicines and health-technology quality, safety and efficacy.
Under Article 2.º a) EDA's stated objective is to help ARMED attain WHO ML3.

[GAP] The full enumerated list of stringent / reference authorities other than EDA accepted by ARMED for the reliance pathway is not yet centralised in a single published document; per-circular Despacho instruments occasionally name additional accepted NRAs (SAHPRA, INFARMED, US FDA, EMA) for product-specific reliance. The Regulamento do Registo de Medicamentos (Decreto Presidencial n.º 315/20) is the source document and is to be extracted in a future pass.

1.3 Fees -- medicines and pharmaceutical activities [OFFICIAL -- Decreto Executivo Conjunto MINFIN e MINSA n.º 1/25 de 14 de Janeiro, Diário da República I Série n.º 9 (14 January 2025); 42 itemised fees published via the ARMED /emolumentos endpoint]

All fees denominated in AOA (Kwanza, Kz).

Manufacturing licences (5 anos):
- Local manufacturing -- injectables: AOA 10,000,000
- Local manufacturing -- oral solids: AOA 7,000,000
- Local manufacturing -- oral liquids / semi-solids: AOA 7,000,000
- Quality control laboratory licensing: AOA 4,000,000

Import / distribution / commercial licences (5 anos):
- Importer + distributor: AOA 2,500,000
- Importer (specialty / especialidade): AOA 370,000
- Importer (restricted -- oil and diamond companies): AOA 800,000
- Importer of industrial precursors: AOA 1,000,000
- Distributor only: AOA 800,000
- Representante: AOA 100,000

Pharmacies (5 anos):
- Capital city Class 1 (1ª Classe): AOA 800,000
- Capital city Class 2 (2ª Classe): AOA 500,000
- Capital city Class 3 (3ª Classe): AOA 250,000
- Interior of country Class 1: AOA 700,000
- Interior Class 2: AOA 400,000
- Interior Class 3: AOA 200,000
- Ervanária / cosmetic establishment: AOA 130,000

Annual inspection certificates:
- Manufacturing / QC laboratory: AOA 80,000
- Importer / distributor: AOA 80,000
- Pharmacies / ervanárias: AOA 25,000

Pharmaceutical inspection at ports of entry:
- Port (40-ft container): AOA 45,000
- Port (20-ft container): AOA 22,000
- Land port of entry (40-ft container): AOA 45,000
- Land port of entry (20-ft container): AOA 22,000
- Airport > 1 pallet: AOA 22,500
- Airport <= 1 pallet: AOA 8,600
- Correios (postal): AOA 5,000

Clinical trials (per product):
- Phase I -- efficacy: AOA 1,300,000
- Phase II / III studies: AOA 1,300,000 (efficacy track)
- Pharmacokinetic / bioequivalence study (BE only): AOA 500,000
- Amendment to a clinical trial: AOA 300,000

Other:
- Advertising authorisation (45-day validity): AOA 400,000
- Display authorisation at public events: AOA 30,000
- Authorisation for inutilisation / destruction of pharmaceutical products: AOA 100,000
- Additional pharmacy services per service: AOA 130,000
- Authorisation for entities operating in pharmaceutical activity in general: AOA 150,000
- Certificate of Import: AOA 9,000
- Customs clearance declaration (Declaração de Desalfandegamento): AOA 9,000
- Renewal of Import/Export Certificate (pharmaceutical entities): AOA 2,500
- Other technical certificates: AOA 30,000
- Other declarations: AOA 2,500

[FIELD -- ARMED /emolumentos API endpoint accessed 2026-05-31] The 42-item fee dataset above is the canonical operational fee schedule maintained by ARMED itself. Where the Decreto Executivo Conjunto 1/25 published in the Diário da República I Série n.º 9 of 14 January 2025 differs, the gazetted version prevails; ARMED's portal is updated regularly to match.

1.4 GMP requirements and inspection fees [OFFICIAL -- Decreto Presidencial n.º 41/24 (Licensing Regulation); ARMED Emolumentos]
GMP inspection is mandatory for all pharmaceutical manufacturers (local and foreign). Local manufacturers are inspected as part of their 5-year licensing cycle (manufacturing licence fees in Section 1.3 above) plus an annual inspection certificate at AOA 80,000.
[OFFICIAL -- ARMED-EDA MoU Article 2.º b)] ARMED recognises EDA-issued GMP certificates. This is the only formally documented bilateral GMP reliance route extracted in this pass.
[GAP] The ARMED list of stringent NRAs whose GMP certificates qualify for waiver of on-site inspection, and the precise waiver procedure, are not centralised in a single extracted document. The Regulamento sobre o Licenciamento (Decreto Presidencial n.º 41/24) is the source; not exhaustively extracted in this pass.

1.5 Renewal of registration
[GAP] AIM validity period and renewal-trigger schedule not directly extracted in this pass; lives in the Regulamento do Registo de Medicamentos (Decreto Presidencial n.º 315/20). The fee schedule treats most operating licences on a 5-year cycle with annual inspection certificates.

1.6 Variations and post-approval changes
[GAP] Variation categorisation (minor / major / notification) and the variation-fee structure are not present in the 42-item Emolumentos endpoint as published, suggesting variations may be covered under the "Other technical certificates" tier (AOA 30,000) or the "Other declarations" tier (AOA 2,500). The Regulamento do Registo de Medicamentos defines the formal categories; not extracted in detail.

1.7 Import / export and authorised ports [OFFICIAL -- ARMED Emolumentos Sections "Certificado de Importação", "Declaração de Desalfandegamento", "Inspecção Farmacêutica"; multiple Circulares DNME/MINSA on import procedures from 2017-2021]
Each pharmaceutical import requires (a) a Certificado de Importação at AOA 9,000, (b) Declaração de Desalfandegamento (customs clearance) at AOA 9,000, plus (c) per-consignment pharmaceutical inspection at port of entry (rates per container size and entry point, see Section 1.3 above).
Renewal of the Import/Export Certificate for pharmaceutical entities is AOA 2,500.
[OFFICIAL -- Circular n.º 014/DSADU-DSIVA-GJ-AGT-2024 sobre os Bens e Mercadorias Isentos e o IVA] Customs/IVA treatment of pharmaceutical goods is governed by joint DSADU/AGT/MINFIN circulars; the 2024 circular consolidates the exemption list.
[OFFICIAL -- multiple DNME/MINSA Circulares 2017-2021] Numerous import-related circulars from DNME/MINSA remain in force on specific product categories (e.g. Circular 14/DNME/MINSA/2020 on technical requirements for licensing).

1.8 Site Master File
[GAP] SMF requirements not extracted in this pass; the standard SADC-CTD / ICH Module 3.2.A.1 location is the assumed default. Verify in the Regulamento do Registo de Medicamentos.

1.9 Establishment / manufacturer / wholesaler / importer / pharmacy licensing [OFFICIAL -- Decreto Presidencial n.º 41/24 de 29 de Janeiro, Regulamento sobre o Licenciamento para o Exercício da Actividade Farmacêutica; ARMED Emolumentos]
The current licensing framework is set by Decreto Presidencial n.º 41/24, which revoked articles 8, 9, 10, 11, 13, 47, 49 of the older Decreto Presidencial n.º 191/10 plus the entirety of Decreto Presidencial n.º 202/21. The Regulamento covers manufacturing, quality-control laboratories, importer / distributor activities, pharmacies (capital and interior, three classes each), ervanárias and cosmetic establishments, and representante roles. See the fee schedule in Section 1.3 for the per-class licensing fees on a 5-year cycle and the corresponding annual inspection certificates.

SECTION 2: MEDICAL DEVICES AND IVDs [OFFICIAL -- Decreto Presidencial n.º 136/21 (ARMED Organic Statute -- ARMED's mandate explicitly includes "Tecnologias de Saúde"); Memorando de Entendimento ARMED-EDA (cooperation framework explicitly covers "dispositivos médicos")]

ARMED's name itself ("Medicamentos e Tecnologias de Saúde") establishes its mandate over both medicines AND health technologies, which encompasses medical devices and IVDs. The legal-basis Decreto Presidencial n.º 136/21 confirms scope. The bilateral ARMED-EDA MoU lists medical devices alongside pharmaceutical products and biologicals as a cooperation area.

[GAP] A dedicated Angolan medical-devices regulation comparable to Mozambique's Decreto 19/2023 was NOT found in the documents reviewed in this pass. The framework appears to operate under the general Regulamento da Actividade Farmacêutica with ARMED's broader Tecnologias de Saúde mandate from Decreto 136/21. Device classification (Class I-III or A-D), class-specific fees, conformity assessment requirements, ISO 13485 mandation status and SaMD framework -- none of these are extracted from the materials reviewed in this pass. The "Decreto Executivo Conjunto MINFIN/MINSA n.º 1/25" fee regulation does not publish device-specific tiers separate from the general pharmaceutical fees in the Emolumentos endpoint.

SECTION 3: COMPLEMENTARY / HERBAL / SUPPLEMENTS [OFFICIAL -- Decreto Presidencial n.º 253/21 (Farmacovigilance regulation explicitly covers "medicamentos tradicionais"); ARMED Emolumentos -- Ervanárias / cosmetic establishment licence AOA 130,000]

Traditional medicines (medicamentos tradicionais) are explicitly within ARMED's pharmacovigilance scope by virtue of Decreto Presidencial n.º 253/21. Ervanárias (traditional-medicine establishments) and cosmetic-product establishments are licensed under the same 5-year Emolumentos framework as pharmacies (AOA 130,000 for the 5-year licence).
[GAP] Detailed pathway, dossier, fee and timeline for phytotherapeutic / supplement / cosmetic product registration not extracted in this pass.

SECTION 3B: BIOLOGICALS / VACCINES [OFFICIAL -- Decreto Presidencial n.º 253/21 (PV scope includes "derivados de sangue e outros produtos de saúde"); ARMED-EDA MoU explicitly lists "produtos biológicos" as a cooperation area]

Biologicals, vaccines and blood-derivative products are within ARMED's mandate and within the bilateral cooperation framework with EDA. The Decreto Executivo n.º 426/21 de 16 de Setembro (which approves the Lista Nacional de Medicamentos) is the published national essential-medicines list.
[GAP] Lot release procedures, RMP requirements, Plasma Master File (PMF), VAMF acceptance and biosimilar pathway specifics are not extracted in this pass.

SECTION 4: CLINICAL TRIALS [OFFICIAL -- ARMED Emolumentos Section "Pedido de autorização para realização de Ensaios Clínicos (Por produto)"]

Clinical-trial application fees (per product):
- Efficacy study (large trials): AOA 1,300,000
- Other PK/PD studies: AOA 1,300,000
- Pharmacokinetic / bioequivalence (BE only): AOA 500,000
- Amendment to an authorised trial: AOA 300,000

[GAP] Ethics-committee approval pathway, GCP standard, investigator residency, liability-insurance requirements, sponsor/CRO obligations, and CT review timelines are NOT extracted from the materials reviewed in this pass. The Regulamento do Registo de Medicamentos (Decreto Presidencial n.º 315/20) is the canonical source.

SECTION 5: POST-MARKET / PHARMACOVIGILANCE [OFFICIAL -- Decreto Presidencial n.º 253/21 de 14 de Outubro 2021 -- "Estabelece as regras do exercício da actividade de farmacovigilância sobre medicamentos de uso humano, medicamentos tradicionais, derivados de sangue e outros produtos de saúde, realizadas pelo Sistema Nacional de Farmacovigilância"; Boletim de Farmacovigilância n.º 1/2025 published]

ARMED operates the Sistema Nacional de Farmacovigilância (SNF) -- the National Pharmacovigilance System. Scope explicitly includes human medicines, traditional medicines, blood derivatives and other health products. The system publishes a periodic Boletim de Farmacovigilância (Bulletin); the n.º 1/2025 edition has been published.
[FIELD -- multiple Despachos n.º DG-ARMED 2025-2026 and earlier DNME/MINSA Despachos] ARMED actively issues Despachos restricting importation, distribution or commercialisation of specific products as a market-surveillance instrument. The current Despacho corpus (29 items in the inventory) indicates an active enforcement programme.
[GAP] Specific ADR reporting timelines (e.g. 15 calendar days serious / 90 days non-serious), PSUR/PBRER cadence, RMP requirements at registration, and recall procedures are not extracted in detail in this pass. Decreto Presidencial 253/21 is the canonical source.

SECTION 6: KEY TIMELINES [OFFICIAL -- Decreto Presidencial n.º 161/21 (Simplification project); Decreto Presidencial n.º 182/22 (Simplification process)]

ARMED has formally committed to a "simplificação" reform programme designed to reduce pharmaceutical-process turnaround times. The reform is gazetted via two Presidential Decretos -- 161/21 (project approval) and 182/22 (broader process governance).
[GAP] Numerical headline AIM-grant timelines per registration category are NOT centrally published in the materials reviewed in this pass. The Regulamento do Registo de Medicamentos (Decreto Presidencial n.º 315/20) defines the deadlines per pathway -- to be extracted in the next pass. Until then, real-world experience and the simplification framework should be referenced when advising clients on Angola filing strategy.

[FIELD -- ARMED-EDA MoU; ARMED Strategic Plan referenced in 136/21 Statute] ARMED has a stated objective of reaching WHO ML3 with EDA technical support. The current process-maturation effort under the Simplification framework targets faster pharmaceutical processes; specific time-reduction metrics are not publicly numbered.

GUIDELINE INDEX
The following Angola Diário da República and ARMED-published documents form the primary references for this KB. All documents were inventoried via the ARMED public API (138 items: 27 Decretos, 29 Despachos, 7 Leis, 66 Circulares, 1 Farmacovigilance bulletin, 8 Outros). 100 of these were downloaded in this pass (149 MB). 92 of the 100 are scanned image-only PDFs requiring OCR for full text extraction.

Constitutional and policy frameworks:
- Decreto Presidencial n.º 180/10 de 18 de Agosto -- Bases Gerais da Política Nacional de Medicamentos (National Medicines Policy bases).
- Decreto Presidencial n.º 191/10 de 1 de Setembro -- Regulamento do Exercício da Actividade Farmacêutica (legacy framework; significant articles revoked by Decretos 136/21 and 41/24).
- Decreto Presidencial n.º 277/20 de 26 de Outubro -- Estatuto Orgânico do Ministério da Saúde (pharmaceutical-aspect provisions revoked by Decreto 136/21).

ARMED creation and governance:
- Decreto Presidencial n.º 136/21 de 1 de Junho -- Cria a ARMED e aprova o Estatuto Orgânico (creates ARMED and approves its Organic Statute).
- Decreto Presidencial n.º 161/21 de 21 de Junho -- Projecto de Simplificação dos Processos Farmacêuticos.
- Decreto Presidencial n.º 182/22 de 22 de Julho -- Processo de Simplificação (broader simplification governance).

Registration, licensing and operational regulations:
- Decreto Presidencial n.º 315/20 de 17 de Dezembro -- Regulamento do Registo de Medicamentos (Medicines Registration Regulation; current).
- Decreto Presidencial n.º 41/24 de 29 de Janeiro -- Regulamento sobre o Licenciamento para o Exercício da Actividade Farmacêutica (current Licensing Regulation; revokes articles 8, 9, 10, 11, 13, 47, 49 of Decreto 191/10 plus all of Decreto 202/21).
- Decreto Presidencial n.º 202/21 de 26 de Agosto -- entirely revoked by Decreto 41/24; historical reference.
- Decreto Presidencial n.º 269/14 de 22 de Setembro -- Central de Compras (procurement) framework.
- Decreto Presidencial n.º 275/11 de 28 de Outubro -- annexed regulation (medicines-related).
- Decreto Presidencial n.º 253/20 de 02 de Outubro -- Política Nacional de Medicamentos.
- Decreto Presidencial n.º 202/19 de 25 de Junho -- Regulamento da Lei da Administração (administration framework).
- Decreto Presidencial n.º 161/21 + 182/22 -- Simplification project / process.
- Lei n.º 14/23 -- Lei de Alteração do Código do IVA (VAT amendment law; affects pharmaceutical IVA treatment).

Fees and customs:
- Decreto Executivo Conjunto MINFIN e MINSA n.º 1/25 de 14 de Janeiro -- ARMED Taxas e Emolumentos (fee regulation; source for the 42-item Emolumentos endpoint).

Pharmacovigilance and post-market:
- Decreto Presidencial n.º 253/21 de 14 de Outubro -- Regulamento sobre a Farmacovigilância.
- Boletim de Farmacovigilância n.º 1/2025 (ARMED).

Bilateral cooperation:
- Memorando de Entendimento entre ARMED (Angola) e EDA (Egipto) sobre Cooperação em Produtos Farmacêuticos, Produtos Biológicos e Dispositivos Médicos -- the only formally documented bilateral reliance cooperation extracted in this pass.

National medicines lists:
- Decreto Executivo n.º 426/21 de 16 de Setembro -- aprova a Lista Nacional de Medicamentos.
- Lista de Medicamentos Registados em Angola até Fevereiro de 2025 (ARMED-published register, periodically updated).

ARMED Despachos -- enforcement and market-surveillance instruments (29 inventoried, 2022-2026): products restricted on import, distribution, or commercialisation are gazetted via DG-ARMED Despachos. Examples include Despacho n.º 18/DG-ARMED/2026 (proibição de entrada de medicamentos em ...), Despacho n.º 12/DG-ARMED/2026 (lista de medicamentos), and Despachos issued jointly with MINSA on import/distribution restrictions.

ARMED Circulares -- operational guidance to industry (66 inventoried, 2013-2026): the corpus includes guidance from the predecessor DNME/MINSA on storage best practices (Circular 001/DNME/MINSA/2019), pharmacy operations, importer requirements, customs procedures, controlled drugs, and product-specific guidance.

Other documents inventoried in the Outros category (8 items): the Memorando de Entendimento ARMED-EDA, the national medicines register (Lista de Medicamentos Registados em Angola até Fevereiro de 2025), additions/amendments to operational circulars, and a clarification note.

Source: https://www.armed.gov.ao -- ARMED public API at armed-production-server.up.railway.app/site-infos and /emolumentos endpoints accessed 2026-05-31

==============================================================
FRPATH AUXILIARY LAYER (Erudee Foundation)
==============================================================

Source: FRPath, https://frpath.org / https://frpportal.public.erudee.org/Africa
Last scraped: 2026-06-04T21:35:58.641151+00:00
Total profiles: 79
Shaami countries covered by FRPath: BW, CI, ET, GH, KE, MW, MZ, NG, RW, TZ, ZA, ZW
Non-Shaami African countries covered by FRPath: DZ, EG, ER, GM, LR, MG, NA, SL, TG, TN, UG, ZM
Regional bodies covered: AMA, CEMAC, EAC, IGAD, WAEMU, WAHO, ZAZIBONA

FRPath® and FRPanorama (TM) are marks of the Erudee Foundation. The information provided in FRPath® is derived from public documents, guidelines, scientific publications, and other reliable sources.

Every FRPath datum should be tagged in answers as:
  [FIELD -- FRPath profile, Erudee Foundation, <profile_url>]
Where FRPath cites an underlying NRA document, flag that the original NRA
source should also be checked.

==============================================================
BY COUNTRY
==============================================================

## BW -- Botswana (Shaami country, KB present)

### Expedited/Fast-track procedure
- Country/region: Botswana (bw) -- Shaami coverage: YES (full KB)
- Authority: Botswana Medicines Regulatory Authority (BoMRA)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: All products
- Timeline hints: 2 months, 36 months, 12 months, 24 months, 8 months
- Process excerpt: For conventional/allopathic medicines: Screening timelines: 2 months. Registration timelines: Normal process: 36 months; Expedited/Fast tracked products: 12 months. For complementary Medicines: Screening timelines: 2 months. Registration timelines: Normal process: 24 months; Expedited/Fast tracked products: 8 months.
- Source: https://frpportal.public.erudee.org/FRP/612df6a031778f0cd746495b

### Medicine Registration Exemption
- Country/region: Botswana (bw) -- Shaami coverage: YES (full KB)
- Authority: Botswana Medicines Regulatory Authority (BoMRA)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: Exemption from Registration may be applied for, only under special circumstances, such as when there is no registered product or, registered alternatives are unavailable, or when conventional therapies have been tried…
- Relies on (reference jurisdictions): Brazil, Canada, China, Europe Japan Mexico Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Tanzania Turkey Uganda United Kingdom United States WHO Zambia Zimbabwe
- Process excerpt: The Authority will communicate the outcome of the application within 72 hours. However, where the application does not meet the Authority’s requirements, queries will be sent to the applicant within the 72 hours. Applicants will be given 48 hours to address the queries following which the Authority will make a regulatory decision.
- Source: https://frpportal.public.erudee.org/FRP/612df908b051f07b2ce6629c

### Non-Routine Assessment of Products for Public Health Emergencies
- Country/region: Botswana (bw) -- Shaami coverage: YES (full KB)
- Authority: Botswana Medicines Regulatory Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: Vaccines and therapeutics each have specific requirements to be eligible for evaluation under the EUL procedure. In order to qualify for assessment under this procedure, the following criteria must be met: (a) The…
- Relies on (reference jurisdictions): ASEAN Algeria Argentina Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA East African Community (EAC) Egypt GHC-GCC India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Malaysia Mexico Moldova, Republic of Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Tunisia Turkey Ukraine United Kingdom United States WHO Zazibona
- Timeline hints: 3 months
- Process excerpt: The Authority shall finalise review of the information received within 3 months.
- Source: https://frpportal.public.erudee.org/FRP/63e7506f8c7e934ec25df320

## CI -- Ivory Coast (Shaami country, KB present)

### Reliance Procedure
- Country/region: Ivory Coast (ci) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: medical products
- Process excerpt: Info not found.
- Source: https://frpportal.public.erudee.org/FRP/66890a0aec369488e4449fd1

### Temporary Use Authorization (ATU)
- Country/region: Ivory Coast (ci) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: Unregistered pharmaceutical products or the unapproved use of registered pharmaceutical products in the context of a public health emergency, to diagnose, treat or prevent serious or life-threatening diseases or…
- Timeline hints: 21 days
- Process excerpt: Two (2) exemption schemes to the marketing authorization procedure are possible in order to make pharmaceutical products that do not have a marketing authorization or certificate of compliance available as quickly as possible in an emergency and/or when there is a public health need. Temporary Use Authorization (ATU): The exceptional use of pharmaceutical products that do not have marketing authorization and are not subject to clinical trials in Côte d'Ivoire is subject to obtaining prior Temporary Use Authorization (ATU) issued by the Ivorian Pharmaceutical Regulatory Authority (AIRP). In…
- Source: https://frpportal.public.erudee.org/FRP/6943ec3f6f2146e6979fe56e

### Procedures for applying for marketing authorisation for vaccines.
- Country/region: Ivory Coast (ci) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: vaccines
- Relies on (reference jurisdictions): WHO
- Process excerpt: Info not found
- Source: https://frpportal.public.erudee.org/FRP/6968dc2f3124481fc7fb8b57

## DZ -- Algeria (NOT in Shaami KB -- FRPath only)

### Autorisation Temporaire d’Utilisation (ATU)
- Country/region: Algeria (dz) -- Shaami coverage: NO -- FRPath only
- Authority: Agence Nationale des Produits Pharmaceutiques (ANPP)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Process excerpt: Info not found
- Source: https://frpportal.public.erudee.org/FRP/60db524fae76d2819954c24a

## EG -- Egypt (NOT in Shaami KB -- FRPath only)

### Fast track procedure
- Country/region: Egypt (eg) -- Shaami coverage: NO -- FRPath only
- Authority: Egyptian Drug Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: imported and locally produced products
- Relies on (reference jurisdictions): Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States
- Timeline hints: 30 working days, 2 years
- Process excerpt: TIMELINES FOR BIOLOGICAL PRODUCTS: 1. Applicant submits inquiry through automated system to receive inquiry approval. (30 working days). 2. Applicant submits pricing file. From date of pricing certificate issuance: 60 WD for imported products; 2 years for local products. 3. Applicant request via e-mail for CTD file submission. (3 WD) 4. Biological Reception Specialist (BRS) arranges an appointment with relevant EDA units. (20 WD). EDA units = Biological Inspection Unit, Stability Unit, Scientific Evaluation Unit, Biovigilance Unit, Reception Unit, Labs. 5. Each EDA unit inform reception BRS…
- Source: https://frpportal.public.erudee.org/FRP/60015967faff0a10f56edfe0

### Biological Products Reliance Pathway (decree 343/2021)
- Country/region: Egypt (eg) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: Biological products
- Relies on (reference jurisdictions): Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States
- Timeline hints: 30 days, 60 days, 5 working days
- Process excerpt: Reliance activities at EDA are applicant driven. Two approaches with different levels of reliance and different time frames are set according to the submitted documents as follows: 1. Level 1 (Abridged Registration / 30 days) - For products approved by EMA and/or FDA approval, with the submission of full assessment report and/or list of questions and answers in addition to CTD. 2. Level 2 (Verification / 60 days) - In case of products with EMA and/or FDA approval with the submission of CTD only. PROCEDURE FOR SUBMISSION. 1. Submission of application: - An optional pre-submission technical…
- Source: https://frpportal.public.erudee.org/FRP/654e733ae1f3710c611ec731

### Emergency Use Application & Approval (EUA) - Medicinal Products
- Country/region: Egypt (eg) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: unlicensed medicinal products for use during public health emergency cases.
- Relies on (reference jurisdictions): Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States, WHO
- Timeline hints: 3 months
- Process excerpt: Target time assessment is in case of emergency, it is permissible to grant MA for any pharmaceutical product, with the exception of some conditions once the generic has been considered eligible for EUA procedure. Pre-Submission Activities: Once the product has been considered eligible for assessment under the EUA procedure based on the eligibility criteria previously mentioned, a detailed technical report is prepared by the Central Administration for Pharmaceutical Products supported by scientific evidences, scientific committee advice (if considered necessary) and market studies to be…
- Source: https://frpportal.public.erudee.org/FRP/65aa24aa0491e2c07d6a45cd

### Emergency Use Application & Approval (EUA) - Biological Products
- Country/region: Egypt (eg) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: unlicensed biological products for use during public health emergency cases.
- Relies on (reference jurisdictions): Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States, WHO
- Process excerpt: PRE-SUBMISSION ACTIVITIES: If considered necessary or desirable by the applicant and EDA, scientific advice request may be performed and a discussion may be held before the actual evaluation process starts. SUBMISSION OF APPLICATIONS: The applicant must submit an application letter to EDA Registration directorate. The application letter should include details of country and sites of manufacture, as well as the presentations proposed for the product. ASSESSMENT OF INFORMATION RECEIVED: Once the product has been considered eligible for assessment under the EUA procedure, a product evaluation…
- Source: https://frpportal.public.erudee.org/FRP/65aa255b0491e2c07d6a45e0

### Reliance pathway for post-approval changes to a registered biotherapeutic product
- Country/region: Egypt (eg) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: This reliance pathway brings benefits to patients, industry, and government by facilitating and accelerating access to quality-assured, effective, and safe medicinal products while saving resources and reducing…
- Relies on (reference jurisdictions): Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States
- Timeline hints: 3 working days, 6 months, 12 months
- Process excerpt: 1. Submission Phase: Marketing Authorization Holders (MAH) request an appointment for submission of PAC by sending an email to bioreg.variation@edaegypt.gov.eg with the variation application form. The MAH shall receive an appointment within 3 working days (WDs) in order to upload the file. On the predefined appointment, the MAH submits the variation package on the electronic portal. 2. Verification Phase: In this phase, the submitted documentation is checked versus the reliance checklist to verify that the mandatory documents are attached. The MAH shall receive an e-mail within 5 WDs showing…
- Source: https://frpportal.public.erudee.org/FRP/66b5cf52c87516c055068edd

### EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)
- Country/region: Egypt (eg) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, joint_assessment, registration, reliance
- Scope: This procedure is applied for biological products only and can be extended to include pharmaceutical and medical devices
- Timeline hints: 15 working days, 60 working days, 45 working days
- Process excerpt: For the purpose of joint assessment of applications for registration of biologicals (pilot phase), there will be two stages: 1. The first application(s) accepted to be submitted will undergo parallel assessment by both EDA and SAHPRA. 2. Later application(s) will undergo alternate assessment by EDA and SAHPRA where both authorities will divide the assessment work of the one submitted application among them. There will be alternate review and peer review of each regulator’s work. SUBMISSION STEPS. 1. The publication of an invitation to submit an expression of interest for pilot biological…
- Source: https://frpportal.public.erudee.org/FRP/671fa7e40837f85b4608cf2f

### Lot Release of Biological Products in Egypt
- Country/region: Egypt (eg) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: biological products
- Timeline hints: 10 working days, 2 working days, 5 working days
- Process excerpt: The lot release for biological products in Egypt will follow one of the following pathways: a) Normal release pathway: in which all biological products will be categorized into three risk groups (low, moderate and high-risk groups). b) Expedited release pathway: Expedited release may be granted in exceptional cases and upon appropriate justification such as: • Product shortage in Egypt • Public health emergency • Biological products donated from international organizations. Batches will be released after evaluation of relevant documents and performing the minimum test items that assure…
- Source: https://frpportal.public.erudee.org/FRP/673dc47dcd1b22de89c6bda2

## ER -- Eritrea (NOT in Shaami KB -- FRPath only)

### Fast track/priority registration
- Country/region: Eritrea (er) -- Shaami coverage: NO -- FRPath only
- Authority: National Medicines and Food Administration (NMFA)
- Pathway type: a verification review (a recognition pathway)
- Buckets: fast_track, recognition, verification
- Scope: generics; biologicals; medical devices; post approval changes (variations); major line extensions
- Relies on (reference jurisdictions): Brazil, Canada, China, EU-EMA, Europe Japan Mexico Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States WHO
- Timeline hints: 90 working days
- Process excerpt: Complete applications eligible for fast track/abridged registration will be processed within 90 working days of receiving the applications
- Source: https://frpportal.public.erudee.org/FRP/612dfc96a518b0fd0e01cf3d

## ET -- Ethiopia (Shaami country, KB present)

### Fast track for locally manufactured and priority medicines
- Country/region: Ethiopia (et) -- Shaami coverage: YES (full KB)
- Authority: Ethiopian Food and Drug Authority
- Pathway type: a verification review (a recognition pathway)
- Buckets: fast_track, recognition, verification
- Relies on (reference jurisdictions): Algeria, Argentina, Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA East African Community (EAC) Egypt Europe GHC-GCC Iceland India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Liechtenstein Malaysia Mexico Moldova, Republic of Norway Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey Ukraine United Kingdom United States WHO
- Timeline hints: 30 days
- Process excerpt: The applicant will be notified of the results of its evaluation within 30 days of its submission
- Source: https://frpportal.public.erudee.org/FRP/60db533dae76d2819954c24c

### Conditional Approval of Medicines
- Country/region: Ethiopia (et) -- Shaami coverage: YES (full KB)
- Authority: Food and Drug Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, conditional, reliance
- Scope: Medicines with indications for seriously debilitating or life-threatening conditions (such as cancer and multi-drug resistant tuberculosis), those used in emergency situations and orphan medicines are major candidates…
- Relies on (reference jurisdictions): Brazil, Canada, China, EU-EMA, Europe Iceland Japan Liechtenstein Mexico Norway Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States WHO
- Process excerpt: The total target (agency) time for assessment is not stated in the guideline.
- Source: https://frpportal.public.erudee.org/FRP/6278dfd9acb65d2ab8be00b1

### Emergency Use Authorization of COVID-19 Vaccine
- Country/region: Ethiopia (et) -- Shaami coverage: YES (full KB)
- Authority: Food and Drug Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: This pathway is for the emergency use authorization (EUA) of COVID-19 vaccines. Issuance of an EUA would require a determination by EFDA that the vaccine’s benefits outweigh its risks based on data from at least one…
- Relies on (reference jurisdictions): Armenia Australia Brazil Canada China EU-EMA Europe Japan Mexico Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States
- Process excerpt: The total target (agency) time for assessment is not stated in the guideline.
- Source: https://frpportal.public.erudee.org/FRP/6278e3e0acb65d2ab8be00ed

### Registration of Low-Risk Medicines
- Country/region: Ethiopia (et) -- Shaami coverage: YES (full KB)
- Authority: Ethiopian Food and Drug Authority (EFDA)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, registration, reliance
- Scope: The general category of products listed below are eligible for market authorization application: a. Keratolytic; b. Anti-dandruff; c. Topical antibacterial; d. pholcodine linctus or a codeine-containing combination…
- Relies on (reference jurisdictions): Australia, Brazil, Canada, China, EU-EMA, Europe Japan Mexico Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States
- Process excerpt: As the low risk medicine applications needs abbreviated review process, shorter target times apply to these types of applications. The Authority may make requests for further information from the applicant if there are issues arising at any stage of the evaluation process and granting the marketing authorization will be based on the outcome of the abbreviated review outcome.
- Source: https://frpportal.public.erudee.org/FRP/6278eab3acb65d2ab8be014c

## GH -- Ghana (Shaami country, KB present)

### Alternative/non routine authorization application pathways – VERIFICATION ROUTE
- Country/region: Ghana (gh) -- Shaami coverage: YES (full KB)
- Authority: Food and Drugs Authority Ghana (FDA Ghana)
- Pathway type: a verification review (a recognition pathway)
- Buckets: recognition, verification
- Relies on (reference jurisdictions): Australia, Brazil, Canada, China, EU-EMA, Europe Iceland Japan Liechtenstein Mexico Norway Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States West African Health Organization (WAHO)
- Timeline hints: 30 working days
- Fee hints: kes 30
- Process excerpt: Verification pathway takes 30 working days (excluding clock stops).
- Source: https://frpportal.public.erudee.org/FRP/5ffb8704a25e74126480cd8c

### Abridged Review
- Country/region: Ghana (gh) -- Shaami coverage: YES (full KB)
- Authority: Ghana FDA
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: Review is applied on the pre-requisite that the product has been previously approved by a stringent regulatory authority such as the United States Food and Drug Administration (US FDA), United Kingdom Medicines and…
- Relies on (reference jurisdictions): Canada, EU-EMA, United Kingdom, United States
- Timeline hints: 266 calendar days
- Process excerpt: 266 calendar days. (This includes both the agency and the industry response time, as per the FDA Ghana website.)
- Source: https://frpportal.public.erudee.org/FRP/63e76a5f8c7e934ec25df4ac

### Emergency Use Authorization (EUA) of Medical Products
- Country/region: Ghana (gh) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: Allopathic Medicines, Biological Products, including Vaccines and Medical Devices.
- Timeline hints: 15 working days
- Process excerpt: The timelines for processing an EUA will depend on the product profile; the existence, if any, of pending applications for the product; the nature of the emergency; and other relevant factors. Although the length of time required for action will vary, the FDA recognizes that it is likely that, in an emergency situation that is occurring or believed imminent, a request for consideration for an EUA will be acted upon within 15 working days.
- Source: https://frpportal.public.erudee.org/FRP/6510497d5326d669b7e71a5f

## GM -- The Gambia (NOT in Shaami KB -- FRPath only)

### Abridged Review
- Country/region: The Gambia (gm) -- Shaami coverage: NO -- FRPath only
- Authority: Medicines Control Agency (MCA) - Gambia
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: All therapeutic products
- Timeline hints: 90 days, 180 days
- Process excerpt: The Agency shall acknowledge receipt of all applications and payment of fees at submission. The Agency shall process an abridged review application within 90 days (compared to 180 days for a normal application for registration of a medicine). The Agency may consider an abridged review for medicines prequalified by WHO or, on a case-by-case basis, for medicines authorised by Regulatory Authorities (RA) recognised by MCA. For registration of medicines in public health emergencies the MCA Gambia shall decide on the timeline on a case-by-case basis.
- Source: https://frpportal.public.erudee.org/FRP/612e781bfe274c9b8432cd96

## KE -- Kenya (Shaami country, KB present)

### Fast track for locally manufactured and priority medicines
- Country/region: Kenya (ke) -- Shaami coverage: YES (full KB)
- Authority: Pharmacy and Poisons Board
- Buckets: fast_track
- Process excerpt: Info not found
- Source: https://frpportal.public.erudee.org/FRP/5ffb85aaa25e74126480cd8b

### Reliance for Regulatory Decision Making in Kenya
- Country/region: Kenya (ke) -- Shaami coverage: YES (full KB)
- Authority: Pharmacy and Poisons Board (PPB)
- Pathway type: a verification review (a recognition pathway)
- Buckets: recognition, reliance, verification
- Scope: The Pharmacy and Poisons Board may apply reliance procedures for granting Marketing Authorization or Emergency Use Authorization (EUA) in the following situations: (a) Product should have been evaluated and listed as a…
- Relies on (reference jurisdictions): Argentina, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, EU-EMA, East African Community (EAC), Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Intergovernmental Authority on Development (IGAD) Region, Ireland, Israel, Italy, Japan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States, WHO
- Timeline hints: 90 calendar days, 7 working days
- Process excerpt: The authority reserves the right to subject all submissions for approval to an ‘abridged’ evaluation of a certain part of the application (e.g., relevant to use under local condition) such as product quality data in relation to climatic conditions and distribution infrastructure and a benefit-risk assessment in relation to use in the local ethnic population, medical practice/culture and patterns of disease and nutrition. Depending on the type verification, the applications will be evaluated within a time line of not exceeding 90 calendar days of regulatory time from the date after obtaining…
- Source: https://frpportal.public.erudee.org/FRP/623b168b15d6584704aba93b

### Emergency Use Application (EUA)
- Country/region: Kenya (ke) -- Shaami coverage: YES (full KB)
- Authority: Pharmacy and Poisons Board (PPB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: The product categories to be reviewed under emergency use will include but not be limited to: (a) Medicines (therapeutics): I. Blood and Blood Product; II. Biotherapeutic products; and III. Chemical products. (b)…
- Relies on (reference jurisdictions): Australia, Brazil, Canada, China, EU-EMA, East African Community (EAC), Iceland, Intergovernmental Authority on Development (IGAD) Region, Japan, Liechtenstein, Mexico, Norway, Saudi Arabia, Singapore, South Korea, Switzerland, Turkey, United Kingdom, United States, WHO
- Timeline hints: 7 calendar days, 30 calendar days
- Process excerpt: Approval timelines shall be determined on a case-by-case basis. In general, the approval timelines for abridged and WHO EUL listed product applications shall be evaluated within 7 calendar days of submission of complete documentation. For initial assessment application (undergoing full assessment pathway), an application shall be reviewed within 30 calendar days. Any subsequent additional information shall be reviewed within 7 calendar days. Screening for eligibility shall be accomplished within 7 calendar days.
- Source: https://frpportal.public.erudee.org/FRP/6248b2eb6ef5aee2425a20c2

### PPB Fast Track, Reliance and Emergency Use Pathways for IVDs Region: AFRICA
- Country/region: Kenya (ke) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, fast_track, reliance
- Scope: PPB defines Fasttrack and emergency/compassionate use pathways that apply to “health products and medical devices,” a category that includes in vitro diagnostic devices. Fasttrack may be full assessment or…
- Process excerpt: .
- Source: https://frpportal.public.erudee.org/FRP/694453156f2146e6979fe7ea

## LR -- Liberia (NOT in Shaami KB -- FRPath only)

### Registration of Medicines
- Country/region: Liberia (lr) -- Shaami coverage: NO -- FRPath only
- Authority: Liberia Medicines and Health Products Regulatory Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, registration, reliance
- Relies on (reference jurisdictions): West African Health Organization (WAHO)
- Process excerpt: The Authority shall acknowledge receipt of all applications at submission and payment of fees and applications shall be processed within three months. Where it becomes necessary to ask for additional information from the applicant, this time period may be lengthened.
- Source: https://frpportal.public.erudee.org/FRP/6315bef4d19c27c7b3d75e44

## MG -- Madagascar (NOT in Shaami KB -- FRPath only)

### Reliance Pathway
- Country/region: Madagascar (mg) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: pharmaceutical products (new chemical entities, biologicals, vaccines), and medical devices (IVDs and male condoms)
- Timeline hints: 3 months, 90 days
- Process excerpt: 3 months (90 days)
- Source: https://frpportal.public.erudee.org/FRP/69a938012a894d5f17e936ff

## MW -- Malawi (Shaami country, KB present)

### Registration of human medicinal products classified for fast-track process
- Country/region: Malawi (mw) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, registration, reliance
- Scope: human medicinal products
- Relies on (reference jurisdictions): WHO
- Timeline hints: 90 calendar days, 180 calendar days
- Process excerpt: There are three processes covered by the fast-track guidelines: 1. WHO PREQUALIFIED MEDICINAL PRODUCTS - Applicant should submit the product dossier for a WHO-prequalified pharmaceutical product to the Authority. The dossier submitted should be the same as submitted to the WHO-PQP during the initial prequalification procedure, and subsequent variation documentation where applicable; - The application should include; a) A completed application form for the registration of the product, including the same technical information as that submitted to WHO/PQP. The technical part of the dossier…
- Source: https://frpportal.public.erudee.org/FRP/69dbebe4e9bf58ff1dcba0f3

## MZ -- Mozambique (Shaami country, KB present)

### Verification Review
- Country/region: Mozambique (mz) -- Shaami coverage: YES (full KB)
- Authority: National Directorate
- Pathway type: a verification review (a recognition pathway)
- Buckets: recognition, verification
- Scope: new chemical entity; generics; biologicals; medical devices; blood products
- Relies on (reference jurisdictions): WHO, Zazibona
- Timeline hints: 365 days, 270 days, 90 days, 360 days, 130 days, 60 days
- Process excerpt: The average time for granting a marketing authorisation for a product, counted from the date of receipt of a valid application, i.e. assessed in a single round without the request for additional information, is as follows: • Full Procedure – 365 days; • Abridged Procedure – 270 days; • Collaborative Procedure (WHO) and by Recognition – 90 days; • SADC ZAZIBONA Collaborative Procedure for products not yet approved – 360 days For expedited applications, as defined by the Resolution on the Prioritisation of Marketing Authorisation for Medicines in Mozambique, the average time for granting a…
- Source: https://frpportal.public.erudee.org/FRP/6316e50ed19c27c7b3d76291

### Abridged Review
- Country/region: Mozambique (mz) -- Shaami coverage: YES (full KB)
- Authority: National Directorate
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: new chemical entity; generics; biologicals; medical devices; blood products
- Relies on (reference jurisdictions): Brazil, Canada, China, EU-EMA, Japan, Mexico, Saudi Arabia, Singapore, South Korea, Switzerland, Taiwan (Chinese Taipei), Turkey, United Kingdom, United States, WHO, Zazibona
- Timeline hints: 365 days, 270 days, 90 days, 360 days, 130 days, 60 days
- Process excerpt: The average time for granting a marketing authorization for a product, counted from the date of receipt of a valid application, i.e. assessed in a single round without the request for additional information, is as follows: • Full Procedure – 365 days • Abridged Procedure – 270 days • Collaborative Procedure (WHO) and by Recognition – 90 days; • SADC ZAZIBONA Collaborative Procedure for products not yet approved – 360 days For expedited applications, as defined by the Resolution on the Prioritisation of Marketing Authorisation for Medicines in Mozambique, the average time for granting a…
- Source: https://frpportal.public.erudee.org/FRP/6316e634d19c27c7b3d7629d

## NA -- Namibia (NOT in Shaami KB -- FRPath only)

### Expedited “fast-track” registration procedure
- Country/region: Namibia (na) -- Shaami coverage: NO -- FRPath only
- Authority: Namibia Medicines Regulatory Council (NMRC)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: All therapeutic products
- Relies on (reference jurisdictions): Canada, EU-EMA, Japan, South Africa, Switzerland, United Kingdom, United States, WHO, Zazibona, Zimbabwe
- Timeline hints: 30 days, 90 days, 6 months
- Process excerpt: 1. Medicine application dossiers are received and screened for completeness using the appropriate screening checklist and a response of the outcome of the screening will be communicated to the applicant within 30 days of receipt. 2. Applications that pass screening will require payment of an application fee to be allocated an application number and progress to the evaluation stage. In the event that an application is incomplete and fails the screening stage, the applicant can re-submit a complete application at a later date. This re-submission will incur another screening fee. 3. A detailed…
- Source: https://frpportal.public.erudee.org/FRP/612dfedb46ceef81c3cb5de1

### Verification Review
- Country/region: Namibia (na) -- Shaami coverage: NO -- FRPath only
- Authority: Namibia Medicines Regulatory Council (NMRC)
- Pathway type: a verification review (a recognition pathway)
- Buckets: recognition, verification
- Scope: All therapeutic products.
- Relies on (reference jurisdictions): Australia, Brazil, China, EU-EMA, Japan, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland, Taiwan (Chinese Taipei), Turkey, United Kingdom, United States, WHO, Zazibona, Zimbabwe
- Timeline hints: 90 calendar days
- Process excerpt: 1. Medicine application dossiers are received and screened for completeness using the appropriate screening checklist and a response of the outcome of the screening will be communicated to the applicant. 2. Applications that pass screening will require payment of application fee to be allocated an application number and progress to the evaluation stage. In the event that an application is incomplete and fails the screening stage, the applicant can re-submit a complete application at a later date. This re-submission will incur another screening fee. 3. A detailed review of the dossier is done…
- Source: https://frpportal.public.erudee.org/FRP/6315dbb0d19c27c7b3d75f7b

### Abridged Review
- Country/region: Namibia (na) -- Shaami coverage: NO -- FRPath only
- Authority: Namibia Medicines Regulatory Council (NMRC)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: All therapeutic products.
- Relies on (reference jurisdictions): Australia, Brazil, Canada, China, EU-EMA, Japan, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland, Taiwan (Chinese Taipei), Turkey, United Kingdom, United States, WHO, Zazibona, Zimbabwe
- Process excerpt: PROCESS FLOW: 1. Medicine application dossiers are received and screened for completeness using the appropriate screening checklist and a response of the outcome of the screening will be communicated to the applicant. 2. Applications that pass screening will require payment of application fee to be allocated an application number and progress to the evaluation stage. In the event that an application is incomplete and fails the screening stage, the applicant can re-submit a complete application at a later date. This re-submission will incur another screening fee. 3. A detailed review of the…
- Source: https://frpportal.public.erudee.org/FRP/6315dc30d19c27c7b3d75f87

## NG -- Nigeria (Shaami country, KB present)

### Registration of Imported Drugs in Nigeria
- Country/region: Nigeria (ng) -- Shaami coverage: YES (full KB)
- Authority: National Agency for Food & Drug Administration & Control (NAFDAC)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, registration, reliance
- Scope: All products. NB: For New Chemical Entities (NCE), there must be evidence that Clinical Trials have been undertaken in the relevant population. Such clinical trial reports must be submitted and reviewed. No combination…
- Process excerpt: The timeline for product registration from acceptance of submissions to issuance of Registration number is one hundred and twenty (120) working days. Please note that the clock stops once compliances are issued.
- Source: https://frpportal.public.erudee.org/FRP/612e6f63cb74beebde8b81cd

### Licensing or Access to COVID-19 Vaccines
- Country/region: Nigeria (ng) -- Shaami coverage: YES (full KB)
- Authority: National Agency for Food & Drug Administration & Control (NAFDAC)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: COVID-19 vaccines for use in public health emergencies.
- Process excerpt: NAFDAC will accept a Rolling Submission and conduct a Rolling Review as it understands that in the pandemic emergency, it is possible that not all documentation for a vaccine will be available at the time of application, and the Agency shall accept that applicants will submit the evidence as it becomes available. It would be expected that the sections on manufacturing, specifications and controls would be available, together with evidence of consistency of manufacture. For nonclinical safety studies, preliminary results should be available. An abridged clinical study to generate data for…
- Source: https://frpportal.public.erudee.org/FRP/63e9da028c7e934ec25df60f

### NAFDAC Medical Devices, Including In-Vitro Diagnostics (IVD) Draft Regulation 2025
- Country/region: Nigeria (ng) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: Covers all classes (A-D) of medical devices including IVDs such as reagents, test kits, instruments, and related accessories Establishes a risk-based classification and a comprehensive regulatory framework aligned with…
- Process excerpt: .
- Source: https://frpportal.public.erudee.org/FRP/6925bb910da2e2a6dc1fdaa9

### NAFDAC Emergency Use and Expedited Approval Pathway for COVID‑19 IVDs and Related Devices
- Country/region: Nigeria (ng) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, fast_track, reliance
- Scope: NAFDAC created an emergency use approval (EUA) and expedited review pathway for COVID‑19 in vitro diagnostic test kits (antibody and antigen), PPE, and related medical devices. Eligibility conditions included prior…
- Relies on (reference jurisdictions): Canada, Germany, Japan, United Kingdom, United States, WHO
- Timeline hints: 10 working days
- Process excerpt: .
- Source: https://frpportal.public.erudee.org/FRP/694455836f2146e6979fe923

## RW -- Rwanda (Shaami country, KB present)

### Authorization for Emergency Use for Medicinal Products, Medical Devices and IVDs
- Country/region: Rwanda (rw) -- Shaami coverage: YES (full KB)
- Authority: Rwanda Food and Drugs Authority (RFDA)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: Authorization for Emergency Use (AEU) allows for the expedited approval of medicinal products, medical devices and IVDs in the following conditions: • The disease for which the product is intended is serious or…
- Timeline hints: 15 working days
- Process excerpt: The timelines for processing of an AEU will depend on the following: a) Product profile; b) The existence, if any, of pending applications for the AEU; c) The nature of the emergency and d) Other relevant factors. Although the length of time required for action will vary, the Rwanda FDA recognizes that it is likely that, in an emergency situation that is occurring or believed imminent, a request for consideration for an AEU will be processed within 15 working days.
- Source: https://frpportal.public.erudee.org/FRP/612e70fb860a08667c5e37ad

### Priority Review (Biological Products)
- Country/region: Rwanda (rw) -- Shaami coverage: YES (full KB)
- Authority: Rwanda Food and Drugs Authority (RFDA)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: Biological products such as vaccines, blood and blood components, allergenics, somatic cells, cellular and gene therapy products, tissues, and recombinant therapeutic proteins.
- Timeline hints: 30 working days
- Process excerpt: After receiving the product application, Rwanda FDA shall proceed with screening of the dossier for completeness. In the event that the dossier is incomplete, it will not be scheduled for assessment and the applicant will be notified within 30 working days and requested to comply with requirements in writing. In case of a positive outcome during the screening, the application will be scheduled for assessment according to the First in First Out (FIFO) rules. Priority assessment may be granted where the product is intended for treatment of rare disease conditions through an expression of…
- Source: https://frpportal.public.erudee.org/FRP/612e7388f076154c15316311

### Priority Review
- Country/region: Rwanda (rw) -- Shaami coverage: YES (full KB)
- Authority: Rwanda Food and Drugs Authority (RFDA)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: All products on condition that the product is intended for treatment of a serious or life-threatening disease.
- Relies on (reference jurisdictions): Australia, Brazil, Canada, China, EU-EMA, East African Community (EAC), Japan, Mexico, Saudi Arabia, Singapore, South Korea, Switzerland, Taiwan (Chinese Taipei), Tanzania, Turkey, United Kingdom, United States, WHO
- Timeline hints: 30 working days, 6 months
- Process excerpt: Rwanda FDA shall complete screening of the dossier for completeness within 30 working days from receiving such application. In the event that the dossier is incomplete, it will be rejected. The applicant will be notified of the rejection. In case of a positive outcome during screening, Rwanda FDA shall notify the marketing authorization holder (MAH) in writing that the screening has been successfully completed and place the dossier in the evaluation queue. Review of application for marketing authorization of a product will follow the appropriate evaluation queue. Priority review may be…
- Source: https://frpportal.public.erudee.org/FRP/612e75a62ce77bcd11fcda97

## SL -- Sierra Leone (NOT in Shaami KB -- FRPath only)

### Expedited/Fast-Track Review Process
- Country/region: Sierra Leone (sl) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: allopathic/medicinal products; medical devices; blood products; post approval changes (variations)
- Timeline hints: 6 months, 21 calendar days
- Process excerpt: 1. Processing of fast-track applications – applications under this category shall have a decision made within three (3) months. 2. Processing of locally manufactured applications- applications under this category shall have a decision made within three (3) months. 3. Processing of new applications (imported medicines) - A decision on a new application will be made within 6 months of receipt of the application. The applicant will be required to provide any requested additional data within 6 months. In case additional time is required, a formal request must be submitted to the PBSL. 4.…
- Source: https://frpportal.public.erudee.org/FRP/6638af3078eed55ccf992ad2

### Listing of specialized or orphan products for importation in Sierra Leone
- Country/region: Sierra Leone (sl) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, orphan, reliance
- Scope: specialized or orphan products: new chemical entity; generics; biologicals; medical devices; blood products
- Timeline hints: 21 working days
- Process excerpt: Within 21 working days
- Source: https://frpportal.public.erudee.org/FRP/6638b43278eed55ccf992b32

### Emergency Use Authorization
- Country/region: Sierra Leone (sl) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: COVID-19 vaccines and therapeutics: new chemical entity; generics; biologicals; medical devices; blood products; post approval changes (variations)
- Relies on (reference jurisdictions): WHO
- Process excerpt: .
- Source: https://frpportal.public.erudee.org/FRP/6638b64b78eed55ccf992b91

## TG -- Togo (NOT in Shaami KB -- FRPath only)

### Homologation procedure
- Country/region: Togo (tg) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Relies on (reference jurisdictions): WHO
- Process excerpt: .
- Source: https://frpportal.public.erudee.org/FRP/654d0687e1f3710c611ec0ac

## TN -- Tunisia (NOT in Shaami KB -- FRPath only)

### Prioritization Request
- Country/region: Tunisia (tn) -- Shaami coverage: NO -- FRPath only
- Authority: DPM Tunisie
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: medicines for human use
- Timeline hints: 20 days, 30 days, 120 days, 60 days
- Process excerpt: Acceptability (screening) = 20 days Applicant response = 30 days Technical assessment = 120 days Applicant response = 120 days for the 1st cycle and 60 days for the 2nd and 3rd cycles 2nd or 3rd Technical Assessment (chemical products) = 60 days 2nd or 3rd Technical Assessment (biological products) = 120 days CTSP stage = 60 days Applicant response = 60 days MA decision = 30 days
- Source: https://frpportal.public.erudee.org/FRP/5fff1f4088f8d3329a3722dd

### Abbreviated (Abridged) Assessment
- Country/region: Tunisia (tn) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: medicinal products for human use (reference, generic, biosimilar, vaccine, etc.) that have been granted marketing authorization by at least one recognized reference authority
- Timeline hints: 90 working days, 30 working days, 10 working days
- Process excerpt: 1. Abbreviated Assessment based on reliance on WHO: The authority will finalize the registration process for applications submitted via this route and will issue the marketing authorization (MA) within 90 working days, from receipt of the WHO/SRA reports, provided that all required documents are duly completed. Target assessment time for variations is 30 working days. 2. Abbreviated Assessment through ANMPS internal procedure: (i) Interested applicants must submit an application to the ANMPS, mentioning the intention to use the regulatory trust route. The model in annex 7 of the ‘WHO…
- Source: https://frpportal.public.erudee.org/FRP/687cc86d91221a41f46cc293

### Verification Procedure
- Country/region: Tunisia (tn) -- Shaami coverage: NO -- FRPath only
- Pathway type: a verification review (a recognition pathway)
- Buckets: recognition, verification
- Scope: Medicinal products for human use, including in particular biological products and vaccines already authorized and marketed by a reference regulatory authority.
- Timeline hints: 10 working days, 30 working days, 60 working days
- Process excerpt: Admissibility (screening) = 10 working days. Applicant response = 30 working days. Marketing authorisation decision = 60 working days. Variations = 30 working days. NB: It should be noted that the clock-stop begins as soon as the ANMPS issues a request for clarification or additional information and ends upon receipt of a complete and satisfactory response from the applicant.
- Source: https://frpportal.public.erudee.org/FRP/687cc8aa91221a41f46cc2b2

### Continuous Assessment
- Country/region: Tunisia (tn) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: medicinal products for human use.
- Process excerpt: Info not found.
- Source: https://frpportal.public.erudee.org/FRP/687cc8dc91221a41f46cc2d1

## TZ -- Tanzania (Shaami country, KB present)

### Fast Track Evaluation
- Country/region: Tanzania (tz) -- Shaami coverage: YES (full KB)
- Authority: Tanzania Medicines and Medical Devices Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: All products
- Relies on (reference jurisdictions): Algeria, Argentina, Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA Egypt Iceland India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Liechtenstein Malaysia Mexico Moldova, Republic of Norway Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey Ukraine United Kingdom United States WHO
- Timeline hints: 90 calendar days
- Process excerpt: Target time = 90 calendar days (excluding applicant's time).
- Source: https://frpportal.public.erudee.org/FRP/5fff1c5788f8d3329a3722dc

### Abridged Review
- Country/region: Tanzania (tz) -- Shaami coverage: YES (full KB)
- Authority: Tanzania Medicines & Medical Devices Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: This pathway is for WHO-prequalified and stringent regulatory authority (SRA)-approved products. The pathway applies to new chemical entities and generic medicines applications for marketing authorisation of medicinal…
- Relies on (reference jurisdictions): Australia, Brazil, Canada, China, EU-EMA, Japan, Mexico, Rwanda, Saudi Arabia, Singapore, South Korea, Switzerland, Taiwan (Chinese Taipei), Turkey, United Kingdom, United States
- Timeline hints: 90 calendar days
- Process excerpt: 90 calendar days
- Source: https://frpportal.public.erudee.org/FRP/6315e34cd19c27c7b3d76071

### Emergency Use Authorization of Medicinal Products
- Country/region: Tanzania (tz) -- Shaami coverage: YES (full KB)
- Authority: Tanzania Medicines & Medical Devices Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: Applications for EUA submission includes candidates from the pharmaceuticals, biologicals including vaccines. Examples may consist: - (a) Use of unapproved indication for a registered product; (b) New Investigational…
- Relies on (reference jurisdictions): ASEAN Algeria Argentina Armenia Australia Austria Azerbaijan Brazil Canada China Colombia Cuba EU-EMA East African Community (EAC) Egypt India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Liechtenstein Malaysia Mexico Moldova, Republic of Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Tunisia Turkey Ukraine United Kingdom United States WHO
- Timeline hints: 2 working days, 15 working days, 10 working days, 3 working days, 5 working days, 45 working days
- Process excerpt: Upon submission of application, screening of the application will be conducted for acceptance of application. Successful applications will proceed for evaluation under the EUA. If no screening queries are raised the application will be recommended for emergency use authorization. After the initial submission of the EUA procedure, application with all the mandatory information for initial assessment, applicants are requested to promptly submit any additional information on the development of the product to TMDA. Any unsatisfactory application may be rejected upon screening or unsatisfactory…
- Source: https://frpportal.public.erudee.org/FRP/63e9e6688c7e934ec25df6a7

### Orphan Medicines
- Country/region: Tanzania (tz) -- Shaami coverage: YES (full KB)
- Authority: Tanzania Medicines & Medical Devices Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, orphan, reliance
- Scope: Orphan medicines
- Timeline hints: 30 days, 5 days, 7 days, 60 days, 2 months
- Process excerpt: An Applicant may submit an application to TFDA at any stage of development of a medicinal product, during review of the application or after marketing authorization has been granted for a different indication to obtain the designation status. Review and approval of the request for designation of an orphan medicines = Within 30 days. Review of responses (if additional information requested) = Within 5 days. Notes to applicant on the outcome of the designation application = Within 7 days. Review and approval of marketing authorization of orphan medicines = Not more than 60 days (2 months) from…
- Source: https://frpportal.public.erudee.org/FRP/63e9e9c88c7e934ec25df73c

### Recognition
- Country/region: Tanzania (tz) -- Shaami coverage: YES (full KB)
- Pathway type: a verification review (a recognition pathway)
- Buckets: recognition, verification
- Scope: TMDA may use reliance through recognition of the other regulatory decision to expedite the approval of marketing authorisation of the medicinal products. TMDA may be engaged in unilateral and mutual recognition with…
- Process excerpt: Info not found.
- Source: https://frpportal.public.erudee.org/FRP/6907362c2988468adbe47a63

### Verification of the sameness
- Country/region: Tanzania (tz) -- Shaami coverage: YES (full KB)
- Pathway type: a verification review (a recognition pathway)
- Buckets: recognition, verification
- Scope: Applicable for verification of the sameness of the human medicinal products approved/registered by TMDA, AMA, EMA, IGAD, WHO, NRAs with WHO-Maturity Level 3/ML4, WLAs, and other recognized Regulatory Authorities.
- Process excerpt: Info not found.
- Source: https://frpportal.public.erudee.org/FRP/690737192988468adbe47a7b

### Accelerated Registration for IVDs through CRPs
- Country/region: Tanzania (tz) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: Covers medical devices, including IVDs, implants, and high-risk devices. Focused on evaluating: Analytical and clinical performance. Local relevance and safety. Expedited review for products addressing urgent public…
- Process excerpt: .
- Source: https://frpportal.public.erudee.org/FRP/6925bd1e0da2e2a6dc1fdb29

## UG -- Uganda (NOT in Shaami KB -- FRPath only)

### NDA Abridged Evaluation Process
- Country/region: Uganda (ug) -- Shaami coverage: NO -- FRPath only
- Authority: Uganda National Drug Authority (NDA)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Relies on (reference jurisdictions): ASEAN Algeria Argentina Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA East African Community (EAC) Egypt GHC-GCC Iceland India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Liechtenstein Malaysia Mexico Moldova, Republic of Norway Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey Ukraine United Kingdom United States Zazibona
- Timeline hints: 120 days, 90 days
- Process excerpt: "Regulatory decision on products already authorized for marketing by SRA and those approved under Article 58 of EU Regulations = 120 days Regulatory decision on MA for WHO Prequalified products = 90 days"
- Source: https://frpportal.public.erudee.org/FRP/5fff209088f8d3329a3722de

### Monitored Emergency Use of Unregistered Investigational Interventional Products (MEURI)
- Country/region: Uganda (ug) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: investigational therapeutics for individual patients outside of clinical trials
- Process excerpt: Given the current legal and regulatory framework, National Drug Authority may only authorize drug-related clinical trials. Based on the premises that the use of unregistered investigational products during public health emergencies is done outside the context of clinical trials, the Minister of Health will delegate the responsibility of the regulatory approval of the Investigational Medicinal Product to the National Drug Authority. Thereafter, in consultation with technical experts who will constitute a National Task Force, will consider and approve the deployment plan following NDA approval…
- Source: https://frpportal.public.erudee.org/FRP/666d7d9f4ab479f7b1af0fbb

### Fast-track assessment of CTD dossier applications
- Country/region: Uganda (ug) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: pharmaceutical products for human use
- Timeline hints: 3 months, 1 month
- Process excerpt: The timeline for feedback on a CTD fast-track application is 3 months. This period does not include additional information if requested. The timeline for feedback on additional information is 1 month.
- Source: https://frpportal.public.erudee.org/FRP/666d84154ab479f7b1af0fe8

## ZA -- South Africa (Shaami country, KB present)

### Reliance-based Evaluation Pathways – ABRIDGED REVIEW
- Country/region: South Africa (za) -- Shaami coverage: YES (full KB)
- Authority: South African Health Products Regulatory Authority (SAHPRA)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: medicines for human use are to be registered using an abridged review pathway.
- Relies on (reference jurisdictions): Australia, Canada, EU-EMA, Europe Japan Switzerland United Kingdom United States WHO Zazibona
- Timeline hints: 90 working days, 200 working days
- Process excerpt: Applicants are to provide SAHPRA with the intended evaluation pathways for Quality and Bioequivalence and Clinical evaluation, along with a brief motivation. The intended evaluation pathways should be indicated on the new registration/variation validation template in the relevant sections. Providing the intended pathways prevents unnecessary screening for reliance documentation in instances where a full review is intended by the applicant. Decisions related to an application’s final evaluation pathway and the extent of reliance on an RRA’s evaluation are fully at SAHPRA’s discretion and will…
- Source: https://frpportal.public.erudee.org/FRP/5fff176d88f8d3329a3722d9

### Reliance-based Evaluation Pathways - RECOGNITION
- Country/region: South Africa (za) -- Shaami coverage: YES (full KB)
- Authority: South African Health Products Regulatory Authority (SAHPRA)
- Pathway type: a verification review (a recognition pathway)
- Buckets: recognition, reliance, verification
- Scope: Medicines for human use.
- Relies on (reference jurisdictions): Australia, Canada, EU-EMA, Europe Japan Switzerland United Kingdom United States WHO Zazibona
- Timeline hints: 90 working days, 200 working days
- Process excerpt: Applicants are to provide SAHPRA with the intended evaluation pathways for Quality and Bioequivalence and Clinical evaluation, along with a brief motivation. The intended evaluation pathways should be indicated on the new registration/variation validation template in the relevant sections. Providing the intended pathways prevents unnecessary screening for reliance documentation in instances where a full review is intended by the applicant. Decisions related to an application’s final evaluation pathway and the extent of reliance on an RRA’s evaluation are fully at SAHPRA’s discretion and will…
- Source: https://frpportal.public.erudee.org/FRP/5fff18bf88f8d3329a3722da

### Reliance-based Evaluation Pathways – VERIFIED REVIEW
- Country/region: South Africa (za) -- Shaami coverage: YES (full KB)
- Authority: South African Health Products Regulatory Authority (SAHPRA)
- Pathway type: a verification review (a recognition pathway)
- Buckets: recognition, reliance, verification
- Scope: Medicines for human use.
- Relies on (reference jurisdictions): Australia, Canada, EU-EMA, Europe Japan Switzerland United Kingdom United States WHO Zazibona
- Timeline hints: 90 working days, 200 working days
- Process excerpt: Applicants are to provide SAHPRA with the intended evaluation pathways for Quality and Bioequivalence and Clinical evaluation, along with a brief motivation. The intended evaluation pathways should be indicated on the new registration/variation validation template in the relevant sections. Providing the intended pathways prevents unnecessary screening for reliance documentation in instances where a full review is intended by the applicant. Decisions related to an application’s final evaluation pathway and the extent of reliance on an RRA’s evaluation are fully at SAHPRA’s discretion and will…
- Source: https://frpportal.public.erudee.org/FRP/5fff1b4f88f8d3329a3722db

### Registration of Candidate COVID-19 vaccines
- Country/region: South Africa (za) -- Shaami coverage: YES (full KB)
- Authority: South African Health Products Regulatory Authority (SAHPRA)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, registration, reliance
- Scope: This pathway is for candidate COVID-19 vaccines.
- Timeline hints: 6 months
- Process excerpt: SAHPRA will allow for the filing of submissions for rolling review. This will allow SAHPRA to review data from early development while later-stage clinical trials are taking place. This strategy will help to expedite the regulatory review process for candidate Covid-19 vaccines. Before filing an application for a rolling review, applicants are to have gathered a certain level of evidence on the safety, quality and efficacy of their vaccine. Applicants should consult with SAHPRA before filing an application for rolling review. To file an application for a rolling review, applicants should at…
- Source: https://frpportal.public.erudee.org/FRP/65102b775326d669b7e718f0

### EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)
- Country/region: South Africa (za) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, joint_assessment, registration, reliance
- Scope: pharmaceuticals, biological products, medical devices
- Timeline hints: 15 working days, 60 working days, 45 working days
- Process excerpt: For the purpose of joint assessment of applications for registration of biologicals (pilot phase), there will be two stages: 1. The first application(s) accepted to be submitted will undergo parallel assessment by both EDA and SAHPRA. 2. Later application(s) will undergo alternate assessment by EDA and SAHPRA where both authorities will divide the assessment work of the one submitted application among them. There will be alternate review and peer review of each regulator’s work. SUBMISSION STEPS. 1. The publication of an invitation to submit an expression of interest for pilot biological…
- Source: https://frpportal.public.erudee.org/FRP/671fa7eb0837f85b4608cf44

### SAHPRA Fast Track Licensing for Medical Devices and In Vitro Diagnostics (IVDs)
- Country/region: South Africa (za) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: Covers Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk) medical devices including IVDs such as reagents, test kits, instruments, and accessories. Licensing includes manufacture,…
- Process excerpt: .
- Source: https://frpportal.public.erudee.org/FRP/6944504c6f2146e6979fe73e

## ZM -- Zambia (NOT in Shaami KB -- FRPath only)

### Verification Review (Type 1)
- Country/region: Zambia (zm) -- Shaami coverage: NO -- FRPath only
- Authority: Zambia Medicines Regulatory Authority
- Pathway type: a verification review (a recognition pathway)
- Buckets: recognition, verification
- Scope: This type of review model is used by ZAMRA for products that have been prequalified by the WHO or approved by stringent regulatory authorities (SRAs). The applicant must demonstrate sameness of the dossier submitted…
- Relies on (reference jurisdictions): Australia, Brazil, Canada, China, EU-EMA, Japan, Mexico, Saudi Arabia, Singapore, South Korea, Switzerland, Taiwan (Chinese Taipei), Turkey, United Kingdom, United States, WHO, Zazibona
- Timeline hints: 90 calendar days
- Process excerpt: The target time for assessment is 90 calendar days for verification review (Type 1).
- Source: https://frpportal.public.erudee.org/FRP/625d2e74acb65d2ab8bddce4

### Abridged review (Type 2)
- Country/region: Zambia (zm) -- Shaami coverage: NO -- FRPath only
- Authority: Zambia Medicines Regulatory Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: This model is used for products that were submitted before 2015. The abridged template was used in the review process. In 2015, the Authority adopted the Quality Overall Summary as the evaluation template following the…
- Timeline hints: 351 calendar days
- Process excerpt: 351 calendar days.
- Source: https://frpportal.public.erudee.org/FRP/625d2e8facb65d2ab8bddcf1

### Fast-track/priority review
- Country/region: Zambia (zm) -- Shaami coverage: NO -- FRPath only
- Authority: Zambia Medicines Regulatory Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: Fast track review model is used for products that are of high public health concern. This is an expedited model in which applications are reviewed within 90 working days. The dossier is submitted in the CTD format.
- Timeline hints: 90 working days, 113 calendar days
- Fee hints: kes 113
- Process excerpt: Fast track review model is used for products that are of high public health concern. This is an expedited model in which applications are reviewed within 90 working days. The dossier is submitted in the CTD format. However, it has been reported that the agency takes 113 calendar days to perform the review.
- Source: https://frpportal.public.erudee.org/FRP/625d2e98acb65d2ab8bddcfe

## ZW -- Zimbabwe (Shaami country, KB present)

### Expedited or “Fast-track” Registration Procedure
- Country/region: Zimbabwe (zw) -- Shaami coverage: YES (full KB)
- Authority: Medicines Control Authority
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, fast_track, reliance
- Scope: All New Chemical Entities (NCEs) and biological applications, generic applications, major variations and line extensions that have prior approval from a reference regulatory authority will be considered for an abridged…
- Relies on (reference jurisdictions): ASEAN Algeria Argentina Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA East African Community (EAC) Egypt GHC-GCC India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Malaysia Mexico Moldova, Republic of Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey Ukraine United Kingdom United States WHO
- Timeline hints: 90 days
- Process excerpt: Target time = 90 days
- Source: https://frpportal.public.erudee.org/FRP/5fff277588f8d3329a3722e1

### Emergency Use Authorization of Medical Products
- Country/region: Zimbabwe (zw) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, emergency_use, reliance
- Scope: Unregistered medical product (allopathic medicines, complementary medicines, biological medicinal products and medical devices) for a declared public health emergency. These products and their uses are not approved,…
- Timeline hints: 2 weeks
- Process excerpt: To allow the MCAZ evaluation process to begin before a determination of actual or potential emergency, MCAZ recommends that a pre-emergency submission be filed using existing processes to the extent feasible and appropriate. The extent of, and timelines for, evaluation of such submission will be determined on a case-by-case basis and will depend on the nature of the emergency. Subject to exigent circumstances beyond MCAZ's control, the Authority anticipates that pre-emergency submissions for high priority activities may be evaluated in a matter of weeks to months. The timelines for…
- Source: https://frpportal.public.erudee.org/FRP/68eb7e4e78487939ec3a24e1

### Reliance Procedure (Medicines approved by National Regulatory Authorities under MoU with MCAZ)
- Country/region: Zimbabwe (zw) -- Shaami coverage: YES (full KB)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: products with marketing authorization issued by National Regulatory Authorities (NRAs) with which Zimbabwe has signed Memoranda of Understanding (MoUs) on regulatory cooperation.
- Process excerpt: All applications submitted under the expedited review pathway shall be processed within a defined regulatory timeframe of ninety (90) calendar days, referred to as MCAZ time. This timeframe represents the period during which the MCAZ actively evaluates the application. It is important to note that MCAZ time excludes any duration taken by the applicant to respond to queries, provide additional documentation, or address deficiencies identified during the review process. Applicants are therefore encouraged to ensure timely and complete responses to facilitate adherence to the expedited review…
- Source: https://frpportal.public.erudee.org/FRP/6a01e37674c273c1aabdcfbe

==============================================================
BY REGION
==============================================================

## AMA -- African Medicines Agency (AMA)

### Continental Listing of Medicinal Products (AMA)
- Country/region: African Medicines Agency (AMA) (AMA) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: Priority Medicinal Products Category 1 and/or 2 as per the Guidance on Eligibility Criteria for Priority Products.
- Participating countries: Algeria, Benin, Botswana, Burkina Faso, Cameroon, Cape Verde Chad Congo, Democratic Republic of the Congo Egypt Ethiopia Gabon Ghana Guinea Kenya Lesotho Mali Mauritius Morocco Namibia Niger Rwanda Senegal Seychelles, Republic of Sierra Leone Tanzania Tunisia Uganda Zambia Zimbabwe
- Relies on (reference jurisdictions): Australia, Austria, Belgium, Brazil, Bulgaria Canada China Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Japan Latvia Liechtenstein Lithuania Luxembourg Malta Mexico Netherlands Norway Poland Portugal Romania Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States WHO
- Timeline hints: 15 calendar days, 80 calendar days, 60 calendar days, 260 calendar days, 90 working days, 60 days
- Process excerpt: The EMP TC will undertake a comprehensive evaluation of the quality, safety, and efficacy of priority medicinal products, based on medicinal products dossiers submitted by the applicants and on an assessment of the GMP/GCP/GLP compliance through relevant continental technical committees under AMRH. The EMP-TC Secretariat will screen each product dossier submitted by an applicant according to an internal Standard Operating Procedure (SOP) before the evaluation can start, for completeness of dossiers, selected pathway, and eligibility as part of priority products for continental assessment.…
- Source: https://frpportal.public.erudee.org/FRP/65f2f6f52bb72ec174a34943

## CEMAC -- Economic and Monetary Community of Central Africa (CEMAC)

### Joint assessments of applications for marketing authorization in the CEMAC zone
- Country/region: Economic and Monetary Community of Central Africa (CEMAC) (CEMAC) -- Shaami coverage: NO -- FRPath only
- Authority: of Economic and Monetary Community
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, joint_assessment, reliance
- Scope: new chemical or biological entities (originator medicines), including enhanced traditional medicines; complex generic products; vaccines; other biologics such as biotherapeutics and similar biotherapeutics (including…
- Participating countries: Cameroon, Central African Republic, Chad, Congo Equatorial Guinea Gabon
- Timeline hints: 90 days, 15 days, 30 days, 60 days, 135 days, 45 days
- Process excerpt: The joint evaluation process of marketing authorization (MA) applications in the CEMAC zone takes place in 3 phases: Phase 1: Call for Expressions of Interest. 1. The Executive Secretary of OCEAC will launch a call for expressions of interest for the marketing of medicines belonging to the CEMAC priority categories identified jointly by OCEAC and the member states. 2. The applicant will compile its product dossier in CTD format and submit the application in a sealed envelope labelled "CEMAC Joint Evaluation Application" to one of the six CEMAC NRAs within 90 days of the publication of the…
- Source: https://frpportal.public.erudee.org/FRP/673de721cd1b22de89c6be9c

## EAC -- East African Community (EAC)

### EAC Medicines Regulatory Harmonization Program
- Country/region: East African Community (EAC) (EAC) -- Shaami coverage: NO -- FRPath only
- Authority: East African Community (EAC)
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, joint_assessment, reliance
- Scope: all pharmaceutical products and biological products including vaccines
- Participating countries: Burundi Congo, Democratic Republic of the Congo Kenya Rwanda Somalia South Sudan Tanzania Uganda Zanzibar
- Relies on (reference jurisdictions): Algeria, Argentina, Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA East African Community (EAC) Egypt Europe GHC-GCC Iceland India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Liechtenstein Malaysia Mexico Moldova, Republic of Norway Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey Ukraine United Kingdom United States WHO
- Timeline hints: 30 working days, 6 months, 12 months
- Process excerpt: The submitted application will be screened for completeness within 30 working days. In the event that the dossier is incomplete, it will be rejected. The applicant will be notified of the rejection and asked to come and collect the dossier. In case of a positive outcome during screening, the NMRA shall notify the MAH in writing that the screening has been successfully completed and place the dossier in the evaluation queue. Review of application for marketing authorization of a product will follow the appropriate evaluation queue. Priority review may be granted where the product is intended…
- Source: https://frpportal.public.erudee.org/FRP/600321a7faff0a10f56ee000

## IGAD -- Intergovernmental Authority on Development (IGAD) Region

### IGAD Joint Assessment Procedure
- Country/region: Intergovernmental Authority on Development (IGAD) Region (IGAD) -- Shaami coverage: NO -- FRPath only
- Authority: Intergovernmental Authority on Development (IGAD) Region
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, joint_assessment, reliance
- Scope: Medicines used for Reproductive Health (Oxytocin, Prostaglandins, Magnesium Sulphate, Tranexamic Acid); Medicines for Neonatal and Child Health (Antidiarrheals (Zinc sulphate products), products for treatment of upper…
- Participating countries: Djibouti Eritrea Ethiopia Kenya Somalia South Sudan Sudan Uganda
- Timeline hints: 30 calendar days, 90 days, 30 working days, 90 working days
- Process excerpt: For an application to qualify for the joint assessment, the applicant should officially express interest in the format provided in Annex 1, the duly completed form should be submitted to the IGAD MRH secretariat at Karim.Wanga@igad.int and the medicinal product dossier should be submitted electronically on the Accumulus platform, the details of the platform (access credentials and orientation on use of the platform) will be shared to the applicants that are eligible based on the screening outcome. JOINT ASSESSMENT PROCESS: The IGAD, in partnership with the NRAs, will coordinate the joint…
- Source: https://frpportal.public.erudee.org/FRP/60a6b5b3303caa378a88c0f1

## WAEMU -- West African Economic and Monetary Union (WAEMU)

### Licensing of Pharmaceuticals for Human Use in WAEMU Member States
- Country/region: West African Economic and Monetary Union (WAEMU) (WAEMU) -- Shaami coverage: NO -- FRPath only
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, reliance
- Scope: This pathway is for pharmaceutical products for human use intended to be placed on the market of a Member State of the Union, in the form of a proprietary medicinal product, a generic medicinal product or a…
- Participating countries: Benin, Burkina Faso, Cote D'Ivoire Guinea-Bissau Mali Niger Senegal Togo
- Timeline hints: 120 days, 360 days, 30 working days
- Process excerpt: DESCRIPTION OF THE MAIN STEPS 1. Receipt of the application for approval. During the approval process, the authority verifies the completeness of the application for approval. This verification will be carried out on the basis of the following criteria: - CTD compliant file - Composition of the dossier in accordance with the type of product and the nature of the application - Sample and certificate of analysis of the deposited batch - Receipt of payment To this end, incomplete applications are not received. For any application for approval, a certificate of submission of the application is…
- Source: https://frpportal.public.erudee.org/FRP/666d6cd74ab479f7b1af0ef1

## WAHO -- West African Health Organization (WAHO)

### West African Health Organization (WAHO) Regional Joint Assessment Procedure for Medicine Registration and Marketing Authorization of Medicinal Products
- Country/region: West African Health Organization (WAHO) (WAHO) -- Shaami coverage: NO -- FRPath only
- Authority: WAHO
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, joint_assessment, reliance
- Scope: New chemical entities, biologicals, biosimilars, blood products, medical devices, generics.
- Participating countries: Benin, Burkina Faso, Cape Verde Cote D'Ivoire Gambia Ghana Guinea Guinea-Bissau Liberia Mali Niger Nigeria Senegal Sierra Leone Togo
- Timeline hints: 133 calendar days, 196 calendar days, 14 days, 30 days, 7 days, 2 years, 60 days
- Process excerpt: Currently, the West Africa has no Regional Medicines Regulatory Agency, which has legal mandate for marketing authorization of medicinal products. In view of this, and within the framework of the West African Medicines Regulatory Harmonization (WA-MRH) Initiative, selected medicines in the regional basket will be authorized through the national authorization procedure, after the joint assessment procedure. In the current operating model of the WA-MRH initiative, an NRA serves as a lead coordinator for a 2-year period and receives, validates and arranges for the assessment of the dossiers and…
- Source: https://frpportal.public.erudee.org/FRP/5fff232788f8d3329a3722df

## ZAZIBONA -- Zazibona

### ZAZIBONA Centralized Joint Assessment Pathway for Pharmaceutical Products (ZAZIBONA CP) [July 2025 to December 2026]
- Country/region: Zazibona (ZAZIBONA) -- Shaami coverage: NO -- FRPath only
- Authority: Zazibona
- Pathway type: an abridged review (a reliance pathway)
- Buckets: abridged, joint_assessment, reliance
- Scope: medical products
- Participating countries: Angola, Botswana, Comoros Congo, Democratic Republic of the Congo Eswatini, Kingdom of (Swaziland) Lesotho Madagascar Malawi Mauritius Mozambique Namibia Seychelles, Republic of South Africa Tanzania Zambia Zimbabwe
- Relies on (reference jurisdictions): Australia, Brazil, Canada, China, EU-EMA, Japan, Mexico, Saudi Arabia, Singapore, South Korea, Switzerland, Taiwan (Chinese Taipei), Turkey, United Kingdom, United States
- Timeline hints: 90 days, 14 working days, 15 days, 12 months, 90days, 9months
- Process excerpt: Applicants using the CP will receive a scientific opinion on the quality of their product. The scientific opinion serves as a recommendation to the participating Member States. All 16 SADC Member States participate either as Active or Non-Active Member States, based on their internal capacity to conduct assessments and current Good Manufacturing Practice (cGMP) inspections, or as Observers. Positive recommendations can be used by applicants for expedited review and registration with the participating Active Member States at the time of lodging an application for registration (marketing…
- Source: https://frpportal.public.erudee.org/FRP/5fff244f88f8d3329a3722e0

==============================================================
BY PATHWAY TYPE (cross-reference index)
==============================================================

## Pathway type bucket: abridged (66 profile(s))
- African Medicines Agency (AMA) (AMA) -- Continental Listing of Medicinal Products (AMA) -- https://frpportal.public.erudee.org/FRP/65f2f6f52bb72ec174a34943
- Algeria (dz) -- Autorisation Temporaire d’Utilisation (ATU) -- https://frpportal.public.erudee.org/FRP/60db524fae76d2819954c24a
- Botswana (bw) -- Expedited/Fast-track procedure -- https://frpportal.public.erudee.org/FRP/612df6a031778f0cd746495b
- Botswana (bw) -- Medicine Registration Exemption -- https://frpportal.public.erudee.org/FRP/612df908b051f07b2ce6629c
- Botswana (bw) -- Non-Routine Assessment of Products for Public Health Emergencies -- https://frpportal.public.erudee.org/FRP/63e7506f8c7e934ec25df320
- East African Community (EAC) (EAC) -- EAC Medicines Regulatory Harmonization Program -- https://frpportal.public.erudee.org/FRP/600321a7faff0a10f56ee000
- Economic and Monetary Community of Central Africa (CEMAC) (CEMAC) -- Joint assessments of applications for marketing authorization in the CEMAC zone -- https://frpportal.public.erudee.org/FRP/673de721cd1b22de89c6be9c
- Egypt (eg) -- Fast track procedure -- https://frpportal.public.erudee.org/FRP/60015967faff0a10f56edfe0
- Egypt (eg) -- Biological Products Reliance Pathway (decree 343/2021) -- https://frpportal.public.erudee.org/FRP/654e733ae1f3710c611ec731
- Egypt (eg) -- Emergency Use Application & Approval (EUA) - Medicinal Products -- https://frpportal.public.erudee.org/FRP/65aa24aa0491e2c07d6a45cd
- Egypt (eg) -- Emergency Use Application & Approval (EUA) - Biological Products -- https://frpportal.public.erudee.org/FRP/65aa255b0491e2c07d6a45e0
- Egypt (eg) -- Reliance pathway for post-approval changes to a registered biotherapeutic product -- https://frpportal.public.erudee.org/FRP/66b5cf52c87516c055068edd
- Egypt (eg) -- EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase) -- https://frpportal.public.erudee.org/FRP/671fa7e40837f85b4608cf2f
- Egypt (eg) -- Lot Release of Biological Products in Egypt -- https://frpportal.public.erudee.org/FRP/673dc47dcd1b22de89c6bda2
- Ethiopia (et) -- Conditional Approval of Medicines -- https://frpportal.public.erudee.org/FRP/6278dfd9acb65d2ab8be00b1
- Ethiopia (et) -- Emergency Use Authorization of COVID-19 Vaccine -- https://frpportal.public.erudee.org/FRP/6278e3e0acb65d2ab8be00ed
- Ethiopia (et) -- Registration of Low-Risk Medicines -- https://frpportal.public.erudee.org/FRP/6278eab3acb65d2ab8be014c
- Ghana (gh) -- Abridged Review -- https://frpportal.public.erudee.org/FRP/63e76a5f8c7e934ec25df4ac
- Ghana (gh) -- Emergency Use Authorization (EUA) of Medical Products -- https://frpportal.public.erudee.org/FRP/6510497d5326d669b7e71a5f
- Intergovernmental Authority on Development (IGAD) Region (IGAD) -- IGAD Joint Assessment Procedure -- https://frpportal.public.erudee.org/FRP/60a6b5b3303caa378a88c0f1
- Ivory Coast (ci) -- Reliance Procedure -- https://frpportal.public.erudee.org/FRP/66890a0aec369488e4449fd1
- Ivory Coast (ci) -- Temporary Use Authorization (ATU) -- https://frpportal.public.erudee.org/FRP/6943ec3f6f2146e6979fe56e
- Ivory Coast (ci) -- Procedures for applying for marketing authorisation for vaccines. -- https://frpportal.public.erudee.org/FRP/6968dc2f3124481fc7fb8b57
- Kenya (ke) -- Emergency Use Application (EUA) -- https://frpportal.public.erudee.org/FRP/6248b2eb6ef5aee2425a20c2
- Kenya (ke) -- PPB Fast Track, Reliance and Emergency Use Pathways for IVDs Region: AFRICA -- https://frpportal.public.erudee.org/FRP/694453156f2146e6979fe7ea
- Liberia (lr) -- Registration of Medicines -- https://frpportal.public.erudee.org/FRP/6315bef4d19c27c7b3d75e44
- Madagascar (mg) -- Reliance Pathway -- https://frpportal.public.erudee.org/FRP/69a938012a894d5f17e936ff
- Malawi (mw) -- Registration of human medicinal products classified for fast-track process -- https://frpportal.public.erudee.org/FRP/69dbebe4e9bf58ff1dcba0f3
- Mozambique (mz) -- Abridged Review -- https://frpportal.public.erudee.org/FRP/6316e634d19c27c7b3d7629d
- Namibia (na) -- Expedited “fast-track” registration procedure -- https://frpportal.public.erudee.org/FRP/612dfedb46ceef81c3cb5de1
- Namibia (na) -- Abridged Review -- https://frpportal.public.erudee.org/FRP/6315dc30d19c27c7b3d75f87
- Nigeria (ng) -- Registration of Imported Drugs in Nigeria -- https://frpportal.public.erudee.org/FRP/612e6f63cb74beebde8b81cd
- Nigeria (ng) -- Licensing or Access to COVID-19 Vaccines -- https://frpportal.public.erudee.org/FRP/63e9da028c7e934ec25df60f
- Nigeria (ng) -- NAFDAC Medical Devices, Including In-Vitro Diagnostics (IVD) Draft Regulation 2025 -- https://frpportal.public.erudee.org/FRP/6925bb910da2e2a6dc1fdaa9
- Nigeria (ng) -- NAFDAC Emergency Use and Expedited Approval Pathway for COVID‑19 IVDs and Related Devices -- https://frpportal.public.erudee.org/FRP/694455836f2146e6979fe923
- Rwanda (rw) -- Authorization for Emergency Use for Medicinal Products, Medical Devices and IVDs -- https://frpportal.public.erudee.org/FRP/612e70fb860a08667c5e37ad
- Rwanda (rw) -- Priority Review (Biological Products) -- https://frpportal.public.erudee.org/FRP/612e7388f076154c15316311
- Rwanda (rw) -- Priority Review -- https://frpportal.public.erudee.org/FRP/612e75a62ce77bcd11fcda97
- Sierra Leone (sl) -- Expedited/Fast-Track Review Process -- https://frpportal.public.erudee.org/FRP/6638af3078eed55ccf992ad2
- Sierra Leone (sl) -- Listing of specialized or orphan products for importation in Sierra Leone -- https://frpportal.public.erudee.org/FRP/6638b43278eed55ccf992b32
- Sierra Leone (sl) -- Emergency Use Authorization -- https://frpportal.public.erudee.org/FRP/6638b64b78eed55ccf992b91
- South Africa (za) -- Reliance-based Evaluation Pathways – ABRIDGED REVIEW -- https://frpportal.public.erudee.org/FRP/5fff176d88f8d3329a3722d9
- South Africa (za) -- Registration of Candidate COVID-19 vaccines -- https://frpportal.public.erudee.org/FRP/65102b775326d669b7e718f0
- South Africa (za) -- EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase) -- https://frpportal.public.erudee.org/FRP/671fa7eb0837f85b4608cf44
- South Africa (za) -- SAHPRA Fast Track Licensing for Medical Devices and In Vitro Diagnostics (IVDs) -- https://frpportal.public.erudee.org/FRP/6944504c6f2146e6979fe73e
- Tanzania (tz) -- Fast Track Evaluation -- https://frpportal.public.erudee.org/FRP/5fff1c5788f8d3329a3722dc
- Tanzania (tz) -- Abridged Review -- https://frpportal.public.erudee.org/FRP/6315e34cd19c27c7b3d76071
- Tanzania (tz) -- Emergency Use Authorization of Medicinal Products -- https://frpportal.public.erudee.org/FRP/63e9e6688c7e934ec25df6a7
- Tanzania (tz) -- Orphan Medicines -- https://frpportal.public.erudee.org/FRP/63e9e9c88c7e934ec25df73c
- Tanzania (tz) -- Accelerated Registration for IVDs through CRPs -- https://frpportal.public.erudee.org/FRP/6925bd1e0da2e2a6dc1fdb29
- The Gambia (gm) -- Abridged Review -- https://frpportal.public.erudee.org/FRP/612e781bfe274c9b8432cd96
- Togo (tg) -- Homologation procedure -- https://frpportal.public.erudee.org/FRP/654d0687e1f3710c611ec0ac
- Tunisia (tn) -- Prioritization Request -- https://frpportal.public.erudee.org/FRP/5fff1f4088f8d3329a3722dd
- Tunisia (tn) -- Abbreviated (Abridged) Assessment -- https://frpportal.public.erudee.org/FRP/687cc86d91221a41f46cc293
- Tunisia (tn) -- Continuous Assessment -- https://frpportal.public.erudee.org/FRP/687cc8dc91221a41f46cc2d1
- Uganda (ug) -- NDA Abridged Evaluation Process -- https://frpportal.public.erudee.org/FRP/5fff209088f8d3329a3722de
- Uganda (ug) -- Monitored Emergency Use of Unregistered Investigational Interventional Products (MEURI) -- https://frpportal.public.erudee.org/FRP/666d7d9f4ab479f7b1af0fbb
- Uganda (ug) -- Fast-track assessment of CTD dossier applications -- https://frpportal.public.erudee.org/FRP/666d84154ab479f7b1af0fe8
- West African Economic and Monetary Union (WAEMU) (WAEMU) -- Licensing of Pharmaceuticals for Human Use in WAEMU Member States -- https://frpportal.public.erudee.org/FRP/666d6cd74ab479f7b1af0ef1
- West African Health Organization (WAHO) (WAHO) -- West African Health Organization (WAHO) Regional Joint Assessment Procedure for Medicine Registration and Marketing Authorization of Medicinal Products -- https://frpportal.public.erudee.org/FRP/5fff232788f8d3329a3722df
- Zambia (zm) -- Abridged review (Type 2) -- https://frpportal.public.erudee.org/FRP/625d2e8facb65d2ab8bddcf1
- Zambia (zm) -- Fast-track/priority review -- https://frpportal.public.erudee.org/FRP/625d2e98acb65d2ab8bddcfe
- Zazibona (ZAZIBONA) -- ZAZIBONA Centralized Joint Assessment Pathway for Pharmaceutical Products (ZAZIBONA CP) [July 2025 to December 2026] -- https://frpportal.public.erudee.org/FRP/5fff244f88f8d3329a3722e0
- Zimbabwe (zw) -- Expedited or “Fast-track” Registration Procedure -- https://frpportal.public.erudee.org/FRP/5fff277588f8d3329a3722e1
- Zimbabwe (zw) -- Emergency Use Authorization of Medical Products -- https://frpportal.public.erudee.org/FRP/68eb7e4e78487939ec3a24e1
- Zimbabwe (zw) -- Reliance Procedure (Medicines approved by National Regulatory Authorities under MoU with MCAZ) -- https://frpportal.public.erudee.org/FRP/6a01e37674c273c1aabdcfbe

## Pathway type bucket: conditional (1 profile(s))
- Ethiopia (et) -- Conditional Approval of Medicines -- https://frpportal.public.erudee.org/FRP/6278dfd9acb65d2ab8be00b1

## Pathway type bucket: emergency_use (15 profile(s))
- Algeria (dz) -- Autorisation Temporaire d’Utilisation (ATU) -- https://frpportal.public.erudee.org/FRP/60db524fae76d2819954c24a
- Botswana (bw) -- Non-Routine Assessment of Products for Public Health Emergencies -- https://frpportal.public.erudee.org/FRP/63e7506f8c7e934ec25df320
- Egypt (eg) -- Emergency Use Application & Approval (EUA) - Medicinal Products -- https://frpportal.public.erudee.org/FRP/65aa24aa0491e2c07d6a45cd
- Egypt (eg) -- Emergency Use Application & Approval (EUA) - Biological Products -- https://frpportal.public.erudee.org/FRP/65aa255b0491e2c07d6a45e0
- Ethiopia (et) -- Emergency Use Authorization of COVID-19 Vaccine -- https://frpportal.public.erudee.org/FRP/6278e3e0acb65d2ab8be00ed
- Ghana (gh) -- Emergency Use Authorization (EUA) of Medical Products -- https://frpportal.public.erudee.org/FRP/6510497d5326d669b7e71a5f
- Ivory Coast (ci) -- Temporary Use Authorization (ATU) -- https://frpportal.public.erudee.org/FRP/6943ec3f6f2146e6979fe56e
- Kenya (ke) -- Emergency Use Application (EUA) -- https://frpportal.public.erudee.org/FRP/6248b2eb6ef5aee2425a20c2
- Kenya (ke) -- PPB Fast Track, Reliance and Emergency Use Pathways for IVDs Region: AFRICA -- https://frpportal.public.erudee.org/FRP/694453156f2146e6979fe7ea
- Nigeria (ng) -- NAFDAC Emergency Use and Expedited Approval Pathway for COVID‑19 IVDs and Related Devices -- https://frpportal.public.erudee.org/FRP/694455836f2146e6979fe923
- Rwanda (rw) -- Authorization for Emergency Use for Medicinal Products, Medical Devices and IVDs -- https://frpportal.public.erudee.org/FRP/612e70fb860a08667c5e37ad
- Sierra Leone (sl) -- Emergency Use Authorization -- https://frpportal.public.erudee.org/FRP/6638b64b78eed55ccf992b91
- Tanzania (tz) -- Emergency Use Authorization of Medicinal Products -- https://frpportal.public.erudee.org/FRP/63e9e6688c7e934ec25df6a7
- Uganda (ug) -- Monitored Emergency Use of Unregistered Investigational Interventional Products (MEURI) -- https://frpportal.public.erudee.org/FRP/666d7d9f4ab479f7b1af0fbb
- Zimbabwe (zw) -- Emergency Use Authorization of Medical Products -- https://frpportal.public.erudee.org/FRP/68eb7e4e78487939ec3a24e1

## Pathway type bucket: fast_track (18 profile(s))
- Botswana (bw) -- Expedited/Fast-track procedure -- https://frpportal.public.erudee.org/FRP/612df6a031778f0cd746495b
- Egypt (eg) -- Fast track procedure -- https://frpportal.public.erudee.org/FRP/60015967faff0a10f56edfe0
- Eritrea (er) -- Fast track/priority registration -- https://frpportal.public.erudee.org/FRP/612dfc96a518b0fd0e01cf3d
- Ethiopia (et) -- Fast track for locally manufactured and priority medicines -- https://frpportal.public.erudee.org/FRP/60db533dae76d2819954c24c
- Kenya (ke) -- Fast track for locally manufactured and priority medicines -- https://frpportal.public.erudee.org/FRP/5ffb85aaa25e74126480cd8b
- Kenya (ke) -- PPB Fast Track, Reliance and Emergency Use Pathways for IVDs Region: AFRICA -- https://frpportal.public.erudee.org/FRP/694453156f2146e6979fe7ea
- Malawi (mw) -- Registration of human medicinal products classified for fast-track process -- https://frpportal.public.erudee.org/FRP/69dbebe4e9bf58ff1dcba0f3
- Namibia (na) -- Expedited “fast-track” registration procedure -- https://frpportal.public.erudee.org/FRP/612dfedb46ceef81c3cb5de1
- Nigeria (ng) -- NAFDAC Emergency Use and Expedited Approval Pathway for COVID‑19 IVDs and Related Devices -- https://frpportal.public.erudee.org/FRP/694455836f2146e6979fe923
- Rwanda (rw) -- Priority Review (Biological Products) -- https://frpportal.public.erudee.org/FRP/612e7388f076154c15316311
- Rwanda (rw) -- Priority Review -- https://frpportal.public.erudee.org/FRP/612e75a62ce77bcd11fcda97
- Sierra Leone (sl) -- Expedited/Fast-Track Review Process -- https://frpportal.public.erudee.org/FRP/6638af3078eed55ccf992ad2
- South Africa (za) -- SAHPRA Fast Track Licensing for Medical Devices and In Vitro Diagnostics (IVDs) -- https://frpportal.public.erudee.org/FRP/6944504c6f2146e6979fe73e
- Tanzania (tz) -- Fast Track Evaluation -- https://frpportal.public.erudee.org/FRP/5fff1c5788f8d3329a3722dc
- Tunisia (tn) -- Prioritization Request -- https://frpportal.public.erudee.org/FRP/5fff1f4088f8d3329a3722dd
- Uganda (ug) -- Fast-track assessment of CTD dossier applications -- https://frpportal.public.erudee.org/FRP/666d84154ab479f7b1af0fe8
- Zambia (zm) -- Fast-track/priority review -- https://frpportal.public.erudee.org/FRP/625d2e98acb65d2ab8bddcfe
- Zimbabwe (zw) -- Expedited or “Fast-track” Registration Procedure -- https://frpportal.public.erudee.org/FRP/5fff277588f8d3329a3722e1

## Pathway type bucket: joint_assessment (7 profile(s))
- East African Community (EAC) (EAC) -- EAC Medicines Regulatory Harmonization Program -- https://frpportal.public.erudee.org/FRP/600321a7faff0a10f56ee000
- Economic and Monetary Community of Central Africa (CEMAC) (CEMAC) -- Joint assessments of applications for marketing authorization in the CEMAC zone -- https://frpportal.public.erudee.org/FRP/673de721cd1b22de89c6be9c
- Egypt (eg) -- EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase) -- https://frpportal.public.erudee.org/FRP/671fa7e40837f85b4608cf2f
- Intergovernmental Authority on Development (IGAD) Region (IGAD) -- IGAD Joint Assessment Procedure -- https://frpportal.public.erudee.org/FRP/60a6b5b3303caa378a88c0f1
- South Africa (za) -- EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase) -- https://frpportal.public.erudee.org/FRP/671fa7eb0837f85b4608cf44
- West African Health Organization (WAHO) (WAHO) -- West African Health Organization (WAHO) Regional Joint Assessment Procedure for Medicine Registration and Marketing Authorization of Medicinal Products -- https://frpportal.public.erudee.org/FRP/5fff232788f8d3329a3722df
- Zazibona (ZAZIBONA) -- ZAZIBONA Centralized Joint Assessment Pathway for Pharmaceutical Products (ZAZIBONA CP) [July 2025 to December 2026] -- https://frpportal.public.erudee.org/FRP/5fff244f88f8d3329a3722e0

## Pathway type bucket: orphan (2 profile(s))
- Sierra Leone (sl) -- Listing of specialized or orphan products for importation in Sierra Leone -- https://frpportal.public.erudee.org/FRP/6638b43278eed55ccf992b32
- Tanzania (tz) -- Orphan Medicines -- https://frpportal.public.erudee.org/FRP/63e9e9c88c7e934ec25df73c

## Pathway type bucket: recognition (12 profile(s))
- Eritrea (er) -- Fast track/priority registration -- https://frpportal.public.erudee.org/FRP/612dfc96a518b0fd0e01cf3d
- Ethiopia (et) -- Fast track for locally manufactured and priority medicines -- https://frpportal.public.erudee.org/FRP/60db533dae76d2819954c24c
- Ghana (gh) -- Alternative/non routine authorization application pathways – VERIFICATION ROUTE -- https://frpportal.public.erudee.org/FRP/5ffb8704a25e74126480cd8c
- Kenya (ke) -- Reliance for Regulatory Decision Making in Kenya -- https://frpportal.public.erudee.org/FRP/623b168b15d6584704aba93b
- Mozambique (mz) -- Verification Review -- https://frpportal.public.erudee.org/FRP/6316e50ed19c27c7b3d76291
- Namibia (na) -- Verification Review -- https://frpportal.public.erudee.org/FRP/6315dbb0d19c27c7b3d75f7b
- South Africa (za) -- Reliance-based Evaluation Pathways - RECOGNITION -- https://frpportal.public.erudee.org/FRP/5fff18bf88f8d3329a3722da
- South Africa (za) -- Reliance-based Evaluation Pathways – VERIFIED REVIEW -- https://frpportal.public.erudee.org/FRP/5fff1b4f88f8d3329a3722db
- Tanzania (tz) -- Recognition -- https://frpportal.public.erudee.org/FRP/6907362c2988468adbe47a63
- Tanzania (tz) -- Verification of the sameness -- https://frpportal.public.erudee.org/FRP/690737192988468adbe47a7b
- Tunisia (tn) -- Verification Procedure -- https://frpportal.public.erudee.org/FRP/687cc8aa91221a41f46cc2b2
- Zambia (zm) -- Verification Review (Type 1) -- https://frpportal.public.erudee.org/FRP/625d2e74acb65d2ab8bddce4

## Pathway type bucket: registration (7 profile(s))
- Egypt (eg) -- EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase) -- https://frpportal.public.erudee.org/FRP/671fa7e40837f85b4608cf2f
- Ethiopia (et) -- Registration of Low-Risk Medicines -- https://frpportal.public.erudee.org/FRP/6278eab3acb65d2ab8be014c
- Liberia (lr) -- Registration of Medicines -- https://frpportal.public.erudee.org/FRP/6315bef4d19c27c7b3d75e44
- Malawi (mw) -- Registration of human medicinal products classified for fast-track process -- https://frpportal.public.erudee.org/FRP/69dbebe4e9bf58ff1dcba0f3
- Nigeria (ng) -- Registration of Imported Drugs in Nigeria -- https://frpportal.public.erudee.org/FRP/612e6f63cb74beebde8b81cd
- South Africa (za) -- Registration of Candidate COVID-19 vaccines -- https://frpportal.public.erudee.org/FRP/65102b775326d669b7e718f0
- South Africa (za) -- EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase) -- https://frpportal.public.erudee.org/FRP/671fa7eb0837f85b4608cf44

## Pathway type bucket: reliance (69 profile(s))
- African Medicines Agency (AMA) (AMA) -- Continental Listing of Medicinal Products (AMA) -- https://frpportal.public.erudee.org/FRP/65f2f6f52bb72ec174a34943
- Algeria (dz) -- Autorisation Temporaire d’Utilisation (ATU) -- https://frpportal.public.erudee.org/FRP/60db524fae76d2819954c24a
- Botswana (bw) -- Expedited/Fast-track procedure -- https://frpportal.public.erudee.org/FRP/612df6a031778f0cd746495b
- Botswana (bw) -- Medicine Registration Exemption -- https://frpportal.public.erudee.org/FRP/612df908b051f07b2ce6629c
- Botswana (bw) -- Non-Routine Assessment of Products for Public Health Emergencies -- https://frpportal.public.erudee.org/FRP/63e7506f8c7e934ec25df320
- East African Community (EAC) (EAC) -- EAC Medicines Regulatory Harmonization Program -- https://frpportal.public.erudee.org/FRP/600321a7faff0a10f56ee000
- Economic and Monetary Community of Central Africa (CEMAC) (CEMAC) -- Joint assessments of applications for marketing authorization in the CEMAC zone -- https://frpportal.public.erudee.org/FRP/673de721cd1b22de89c6be9c
- Egypt (eg) -- Fast track procedure -- https://frpportal.public.erudee.org/FRP/60015967faff0a10f56edfe0
- Egypt (eg) -- Biological Products Reliance Pathway (decree 343/2021) -- https://frpportal.public.erudee.org/FRP/654e733ae1f3710c611ec731
- Egypt (eg) -- Emergency Use Application & Approval (EUA) - Medicinal Products -- https://frpportal.public.erudee.org/FRP/65aa24aa0491e2c07d6a45cd
- Egypt (eg) -- Emergency Use Application & Approval (EUA) - Biological Products -- https://frpportal.public.erudee.org/FRP/65aa255b0491e2c07d6a45e0
- Egypt (eg) -- Reliance pathway for post-approval changes to a registered biotherapeutic product -- https://frpportal.public.erudee.org/FRP/66b5cf52c87516c055068edd
- Egypt (eg) -- EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase) -- https://frpportal.public.erudee.org/FRP/671fa7e40837f85b4608cf2f
- Egypt (eg) -- Lot Release of Biological Products in Egypt -- https://frpportal.public.erudee.org/FRP/673dc47dcd1b22de89c6bda2
- Ethiopia (et) -- Conditional Approval of Medicines -- https://frpportal.public.erudee.org/FRP/6278dfd9acb65d2ab8be00b1
- Ethiopia (et) -- Emergency Use Authorization of COVID-19 Vaccine -- https://frpportal.public.erudee.org/FRP/6278e3e0acb65d2ab8be00ed
- Ethiopia (et) -- Registration of Low-Risk Medicines -- https://frpportal.public.erudee.org/FRP/6278eab3acb65d2ab8be014c
- Ghana (gh) -- Abridged Review -- https://frpportal.public.erudee.org/FRP/63e76a5f8c7e934ec25df4ac
- Ghana (gh) -- Emergency Use Authorization (EUA) of Medical Products -- https://frpportal.public.erudee.org/FRP/6510497d5326d669b7e71a5f
- Intergovernmental Authority on Development (IGAD) Region (IGAD) -- IGAD Joint Assessment Procedure -- https://frpportal.public.erudee.org/FRP/60a6b5b3303caa378a88c0f1
- Ivory Coast (ci) -- Reliance Procedure -- https://frpportal.public.erudee.org/FRP/66890a0aec369488e4449fd1
- Ivory Coast (ci) -- Temporary Use Authorization (ATU) -- https://frpportal.public.erudee.org/FRP/6943ec3f6f2146e6979fe56e
- Ivory Coast (ci) -- Procedures for applying for marketing authorisation for vaccines. -- https://frpportal.public.erudee.org/FRP/6968dc2f3124481fc7fb8b57
- Kenya (ke) -- Reliance for Regulatory Decision Making in Kenya -- https://frpportal.public.erudee.org/FRP/623b168b15d6584704aba93b
- Kenya (ke) -- Emergency Use Application (EUA) -- https://frpportal.public.erudee.org/FRP/6248b2eb6ef5aee2425a20c2
- Kenya (ke) -- PPB Fast Track, Reliance and Emergency Use Pathways for IVDs Region: AFRICA -- https://frpportal.public.erudee.org/FRP/694453156f2146e6979fe7ea
- Liberia (lr) -- Registration of Medicines -- https://frpportal.public.erudee.org/FRP/6315bef4d19c27c7b3d75e44
- Madagascar (mg) -- Reliance Pathway -- https://frpportal.public.erudee.org/FRP/69a938012a894d5f17e936ff
- Malawi (mw) -- Registration of human medicinal products classified for fast-track process -- https://frpportal.public.erudee.org/FRP/69dbebe4e9bf58ff1dcba0f3
- Mozambique (mz) -- Abridged Review -- https://frpportal.public.erudee.org/FRP/6316e634d19c27c7b3d7629d
- Namibia (na) -- Expedited “fast-track” registration procedure -- https://frpportal.public.erudee.org/FRP/612dfedb46ceef81c3cb5de1
- Namibia (na) -- Abridged Review -- https://frpportal.public.erudee.org/FRP/6315dc30d19c27c7b3d75f87
- Nigeria (ng) -- Registration of Imported Drugs in Nigeria -- https://frpportal.public.erudee.org/FRP/612e6f63cb74beebde8b81cd
- Nigeria (ng) -- Licensing or Access to COVID-19 Vaccines -- https://frpportal.public.erudee.org/FRP/63e9da028c7e934ec25df60f
- Nigeria (ng) -- NAFDAC Medical Devices, Including In-Vitro Diagnostics (IVD) Draft Regulation 2025 -- https://frpportal.public.erudee.org/FRP/6925bb910da2e2a6dc1fdaa9
- Nigeria (ng) -- NAFDAC Emergency Use and Expedited Approval Pathway for COVID‑19 IVDs and Related Devices -- https://frpportal.public.erudee.org/FRP/694455836f2146e6979fe923
- Rwanda (rw) -- Authorization for Emergency Use for Medicinal Products, Medical Devices and IVDs -- https://frpportal.public.erudee.org/FRP/612e70fb860a08667c5e37ad
- Rwanda (rw) -- Priority Review (Biological Products) -- https://frpportal.public.erudee.org/FRP/612e7388f076154c15316311
- Rwanda (rw) -- Priority Review -- https://frpportal.public.erudee.org/FRP/612e75a62ce77bcd11fcda97
- Sierra Leone (sl) -- Expedited/Fast-Track Review Process -- https://frpportal.public.erudee.org/FRP/6638af3078eed55ccf992ad2
- Sierra Leone (sl) -- Listing of specialized or orphan products for importation in Sierra Leone -- https://frpportal.public.erudee.org/FRP/6638b43278eed55ccf992b32
- Sierra Leone (sl) -- Emergency Use Authorization -- https://frpportal.public.erudee.org/FRP/6638b64b78eed55ccf992b91
- South Africa (za) -- Reliance-based Evaluation Pathways – ABRIDGED REVIEW -- https://frpportal.public.erudee.org/FRP/5fff176d88f8d3329a3722d9
- South Africa (za) -- Reliance-based Evaluation Pathways - RECOGNITION -- https://frpportal.public.erudee.org/FRP/5fff18bf88f8d3329a3722da
- South Africa (za) -- Reliance-based Evaluation Pathways – VERIFIED REVIEW -- https://frpportal.public.erudee.org/FRP/5fff1b4f88f8d3329a3722db
- South Africa (za) -- Registration of Candidate COVID-19 vaccines -- https://frpportal.public.erudee.org/FRP/65102b775326d669b7e718f0
- South Africa (za) -- EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase) -- https://frpportal.public.erudee.org/FRP/671fa7eb0837f85b4608cf44
- South Africa (za) -- SAHPRA Fast Track Licensing for Medical Devices and In Vitro Diagnostics (IVDs) -- https://frpportal.public.erudee.org/FRP/6944504c6f2146e6979fe73e
- Tanzania (tz) -- Fast Track Evaluation -- https://frpportal.public.erudee.org/FRP/5fff1c5788f8d3329a3722dc
- Tanzania (tz) -- Abridged Review -- https://frpportal.public.erudee.org/FRP/6315e34cd19c27c7b3d76071
- Tanzania (tz) -- Emergency Use Authorization of Medicinal Products -- https://frpportal.public.erudee.org/FRP/63e9e6688c7e934ec25df6a7
- Tanzania (tz) -- Orphan Medicines -- https://frpportal.public.erudee.org/FRP/63e9e9c88c7e934ec25df73c
- Tanzania (tz) -- Accelerated Registration for IVDs through CRPs -- https://frpportal.public.erudee.org/FRP/6925bd1e0da2e2a6dc1fdb29
- The Gambia (gm) -- Abridged Review -- https://frpportal.public.erudee.org/FRP/612e781bfe274c9b8432cd96
- Togo (tg) -- Homologation procedure -- https://frpportal.public.erudee.org/FRP/654d0687e1f3710c611ec0ac
- Tunisia (tn) -- Prioritization Request -- https://frpportal.public.erudee.org/FRP/5fff1f4088f8d3329a3722dd
- Tunisia (tn) -- Abbreviated (Abridged) Assessment -- https://frpportal.public.erudee.org/FRP/687cc86d91221a41f46cc293
- Tunisia (tn) -- Continuous Assessment -- https://frpportal.public.erudee.org/FRP/687cc8dc91221a41f46cc2d1
- Uganda (ug) -- NDA Abridged Evaluation Process -- https://frpportal.public.erudee.org/FRP/5fff209088f8d3329a3722de
- Uganda (ug) -- Monitored Emergency Use of Unregistered Investigational Interventional Products (MEURI) -- https://frpportal.public.erudee.org/FRP/666d7d9f4ab479f7b1af0fbb
- Uganda (ug) -- Fast-track assessment of CTD dossier applications -- https://frpportal.public.erudee.org/FRP/666d84154ab479f7b1af0fe8
- West African Economic and Monetary Union (WAEMU) (WAEMU) -- Licensing of Pharmaceuticals for Human Use in WAEMU Member States -- https://frpportal.public.erudee.org/FRP/666d6cd74ab479f7b1af0ef1
- West African Health Organization (WAHO) (WAHO) -- West African Health Organization (WAHO) Regional Joint Assessment Procedure for Medicine Registration and Marketing Authorization of Medicinal Products -- https://frpportal.public.erudee.org/FRP/5fff232788f8d3329a3722df
- Zambia (zm) -- Abridged review (Type 2) -- https://frpportal.public.erudee.org/FRP/625d2e8facb65d2ab8bddcf1
- Zambia (zm) -- Fast-track/priority review -- https://frpportal.public.erudee.org/FRP/625d2e98acb65d2ab8bddcfe
- Zazibona (ZAZIBONA) -- ZAZIBONA Centralized Joint Assessment Pathway for Pharmaceutical Products (ZAZIBONA CP) [July 2025 to December 2026] -- https://frpportal.public.erudee.org/FRP/5fff244f88f8d3329a3722e0
- Zimbabwe (zw) -- Expedited or “Fast-track” Registration Procedure -- https://frpportal.public.erudee.org/FRP/5fff277588f8d3329a3722e1
- Zimbabwe (zw) -- Emergency Use Authorization of Medical Products -- https://frpportal.public.erudee.org/FRP/68eb7e4e78487939ec3a24e1
- Zimbabwe (zw) -- Reliance Procedure (Medicines approved by National Regulatory Authorities under MoU with MCAZ) -- https://frpportal.public.erudee.org/FRP/6a01e37674c273c1aabdcfbe

## Pathway type bucket: verification (12 profile(s))
- Eritrea (er) -- Fast track/priority registration -- https://frpportal.public.erudee.org/FRP/612dfc96a518b0fd0e01cf3d
- Ethiopia (et) -- Fast track for locally manufactured and priority medicines -- https://frpportal.public.erudee.org/FRP/60db533dae76d2819954c24c
- Ghana (gh) -- Alternative/non routine authorization application pathways – VERIFICATION ROUTE -- https://frpportal.public.erudee.org/FRP/5ffb8704a25e74126480cd8c
- Kenya (ke) -- Reliance for Regulatory Decision Making in Kenya -- https://frpportal.public.erudee.org/FRP/623b168b15d6584704aba93b
- Mozambique (mz) -- Verification Review -- https://frpportal.public.erudee.org/FRP/6316e50ed19c27c7b3d76291
- Namibia (na) -- Verification Review -- https://frpportal.public.erudee.org/FRP/6315dbb0d19c27c7b3d75f7b
- South Africa (za) -- Reliance-based Evaluation Pathways - RECOGNITION -- https://frpportal.public.erudee.org/FRP/5fff18bf88f8d3329a3722da
- South Africa (za) -- Reliance-based Evaluation Pathways – VERIFIED REVIEW -- https://frpportal.public.erudee.org/FRP/5fff1b4f88f8d3329a3722db
- Tanzania (tz) -- Recognition -- https://frpportal.public.erudee.org/FRP/6907362c2988468adbe47a63
- Tanzania (tz) -- Verification of the sameness -- https://frpportal.public.erudee.org/FRP/690737192988468adbe47a7b
- Tunisia (tn) -- Verification Procedure -- https://frpportal.public.erudee.org/FRP/687cc8aa91221a41f46cc2b2
- Zambia (zm) -- Verification Review (Type 1) -- https://frpportal.public.erudee.org/FRP/625d2e74acb65d2ab8bddce4

==============================================================
END FRPATH AUXILIARY LAYER
==============================================================

Accelerated pathway intelligence enriched by FRPath® (Erudee Foundation, frpath.org). FRPath® is a mark of the Erudee Foundation. The information so obtained is believed to be accurate; users are encouraged to validate it before relying on it for filing decisions.

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