Search across 69,000+ products, devices, trials, documents, and organizations
| Type | Title & Description | Details | Country | Status |
|---|---|---|---|---|
| Resource |
AU Model Law on Medical Products Regulation – French
AU Model Law multilingual versions
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Cat: AU Model Law & Continental Regulatory Policy Instruments
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| Resource |
AU Model Law on Medical Products Regulation – Arabic
AU Model Law multilingual versions
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Cat: AU Model Law & Continental Regulatory Policy Instruments
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| Resource |
AU Model Law on Medical Products Regulation – Portuguese
AU Model Law multilingual versions
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Cat: AU Model Law & Continental Regulatory Policy Instruments
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| Resource |
NAFDAC Public Alert No. 010/2025 – Fake “Wonder Calcium” product (2025)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
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Cat: News & Regulatory Alerts (Africa Medicines Regulation)
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| Resource |
MCAZ – Warning: “Handy Heroes” (adulterated product alert) (2025)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
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Cat: News & Regulatory Alerts (Africa Medicines Regulation)
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| Resource |
TMDA Public Notice – Expression of Interest: Evaluators of Medicinal Products and Medical Devices (2024)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
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Cat: News & Regulatory Alerts (Africa Medicines Regulation)
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| Resource |
AMRH – Call for industry applications: Pilot of continental listing of medicinal products (2025)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
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Cat: News & Regulatory Alerts (Africa Medicines Regulation)
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| Resource |
AMRH – Call for industry applications: Mpox candidate medicinal products (expedited evaluation) (2025)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
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Cat: News & Regulatory Alerts (Africa Medicines Regulation)
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| Resource |
Applicants: Biotherapeutic Products (EMP-TC guidance PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
CTD Product Dossier Guideline (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Renewal of Registered Human Pharma Products (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Compendium: Marketing Authorisation of Medicinal Products (PDF, July 2020)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Applicants: Biosimilar Products (EMP-TC guidance PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Guidance: Eligibility Criteria for Priority Products (AMRH)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Guidelines: Registration of Drug Products Made in Nigeria (2025 PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Guidelines: Registration of Imported Drug Products (2025 PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Guidelines: Variations on Registered Medicinal Products (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Call: Pilot of Continental Listing of Medicinal Products (AMRH)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Guidelines: Labelling Format/Content for Medicinal Products (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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— | — |
| Resource |
Guidelines: Import/Export of Pharma Products & Raw Materials (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Call: Mpox Candidate Medicinal Products – Expedited Evaluation
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
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| Resource |
Kenya health products registration rules (Legal Notice, PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
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| Resource |
AU Model Law – Overview Page
Continental legal and policy frameworks supporting harmonised regulation of medical products, including the AU Model Law and supporting policy briefs.
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Cat: AU Model Law & Continental Regulatory Policy Instruments
|
— | — |
| Resource |
AU Model Law (PDF)
Continental legal and policy frameworks supporting harmonised regulation of medical products, including the AU Model Law and supporting policy briefs.
|
Cat: AU Model Law & Continental Regulatory Policy Instruments
|
— | — |
| Resource |
AU Model Law (Annotated Copy)
Continental legal and policy frameworks supporting harmonised regulation of medical products, including the AU Model Law and supporting policy briefs.
|
Cat: AU Model Law & Continental Regulatory Policy Instruments
|
— | — |
| Resource |
PATH Policy Brief on AU Model Law
Continental legal and policy frameworks supporting harmonised regulation of medical products, including the AU Model Law and supporting policy briefs.
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Cat: AU Model Law & Continental Regulatory Policy Instruments
|
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| Resource |
African Medicines Quality Forum (AMQF-TC)
Resources supporting medicines quality assurance, pharmacovigilance, post-market surveillance and combating substandard/falsified medical products.
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Cat: Medicines Quality, Pharmacovigilance & Surveillance (AMQF and related)
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| Resource |
AMQF Pharmaceutical Laboratory Equipment Management Guideline (PDF, 2024)
Resources supporting medicines quality assurance, pharmacovigilance, post-market surveillance and combating substandard/falsified medical products.
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Cat: Medicines Quality, Pharmacovigilance & Surveillance (AMQF and related)
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| Resource |
USP PQM+ – AMQF Overview
Resources supporting medicines quality assurance, pharmacovigilance, post-market surveillance and combating substandard/falsified medical products.
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Cat: Medicines Quality, Pharmacovigilance & Surveillance (AMQF and related)
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| Resource |
EDQM–Africa Regulatory Strengthening
Resources supporting medicines quality assurance, pharmacovigilance, post-market surveillance and combating substandard/falsified medical products.
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Cat: Medicines Quality, Pharmacovigilance & Surveillance (AMQF and related)
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| Resource |
WHO: Regional joint activities and work-sharing – landing
WHO global benchmarking tools, regulatory reliance references and international guidance frequently used by African NRAs and regional initiatives.
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Cat: WHO & Global Benchmarking / Reliance Reference Materials
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| Resource |
WHO Regional Work-Sharing & Joint Reviews
WHO global benchmarking tools, regulatory reliance references and international guidance frequently used by African NRAs and regional initiatives.
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Cat: WHO & Global Benchmarking / Reliance Reference Materials
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| Resource |
NAFDAC Public Alert No. 11/2025 – Recall by Sun Pharma/Glenmark/Zydus (2025)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
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Cat: News & Regulatory Alerts (Africa Medicines Regulation)
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| Resource |
WHO – Regional joint activities and work-sharing (reference) (ongoing)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
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Cat: News & Regulatory Alerts (Africa Medicines Regulation)
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| Resource |
EMP-TC Continental Procedure (AMRH publication page)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Marketing Authorisation: Procedural Aspects (Human Pharma) (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Rwanda medicines registration regulation draft (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
TMDA: Regulatory Reliance for Marketing Authorisation (PDF, July 2025)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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| Resource |
Malawi PMRA: Fast Track Registration Guideline (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
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Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
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