African Medicines Regulation Resource Library

Comprehensive collection of authoritative resources on medicines regulation, harmonization, and policy frameworks across Africa

African Medicines Agency (AMA) – Treaty, Legal & Institutional

Official AU and partner resources on the establishment, treaty instruments, institutional framework, operationalisation and cooperation arrangements of the African Medicines Agency (AMA).

Web Page AMA Treaty (Official AU Page) Access →
PDF AMA Status List (PDF – signatures/ratifications) Access →
PDF AMA Treaty – French (PDF) Access →
PDF AMA Treaty (PDF – English) Access →
PDF AMA Infographic (English) Access →
PDF AMA Treaty – Arabic (PDF) Access →
Press Release AMA Treaty Entry into Force (Press Release) Access →
PDF AMA Infographic (English – alternate AU copy) Access →
PDF AMA Treaty – Portuguese (PDF) Access →
Web Page AMA FAQs Access →
Web Page AU AMA Infographics landing page Access →
PDF AMA Institutional Framework Access →
PDF AMA Business Plan (Draft) Access →
PDF AMA Legal Framework Access →
Web Page EMA–AMA Cooperation Overview Access →
PDF AMA Treaty (PDF – French) Access →
PDF AMA Treaty (PDF – Arabic) Access →
PDF AMA Treaty (PDF – Portuguese) Access →
PDF AMA Infographic (French) Access →

Global Standards & IMDRF

International Medical Device Regulators Forum standards frequently referenced by African NRAs.

Guidelines IMDRF: Principles of Labelling for Medical Devices & IVDs (Edition 2, 2024) Access →

AU Model Law & Continental Regulatory Policy Instruments

Continental legal and policy frameworks supporting harmonised regulation of medical products, including the AU Model Law and supporting policy briefs.

Web Page AU Model Law – Overview Page Access →
PDF AU Model Law on Medical Products Regulation – French Access →
PDF AU Model Law (PDF) Access →
PDF AU Model Law on Medical Products Regulation – Arabic Access →
PDF AU Model Law (Annotated Copy) Access →
PDF AU Model Law on Medical Products Regulation – Portuguese Access →
PDF PATH Policy Brief on AU Model Law Access →

Regional Harmonisation Mechanisms (RECs & Regional Initiatives)

Regional work-sharing / joint assessment procedures and harmonisation mechanisms implemented by RECs and regional initiatives (EAC-MRH, ECOWAS/WAHO, ZaZiBoNa, etc.).

Web Page East African Community (EAC-MRH) - Documents Access →
Web Page EAC-MRH Document Repository (category page) Access →
PDF ECOWAS Regional Pharmaceutical Plan (ERPP) (PDF) Access →
Guidelines ZaZiBoNa Guidelines index Access →
Guidelines EAC Medicines Regulatory Guidelines Access →
Guidelines EAC Medicines Regulatory Guidelines (index page) Access →
Guidelines ZaZiBoNa GMP Guidelines (page) Access →
PDF ECOWAS/WAHO - Regional Joint Medicines Assessment Procedure Access →
PDF EAC Joint Regulatory Procedures Brochure (PDF, June 2020) Access →
Web Page ZaZiBoNa FAQs Access →
PDF ECOWAS Joint Assessment Procedure (Edited) Access →
Web Page EAC MRH Programme page (includes PV/APIMF tool links) Access →
Web Page ZaZiBoNa National Registers (index) Access →
Portal ZaZiBoNa Initiative Access →
Report EAC Repository Annual Report 2018–2019 Access →
Web Page ZaZiBoNa home/centralised submission notice Access →
Web Page About ZaZiBoNa Access →
PDF Early EAC MRH progress deck (guideline development overview) Access →
PDF ZaZiBoNa presentation (SAHPRA-hosted PDF) Access →
Web Page SADC - Quality Assured Medicines Access →

Medical Devices & Diagnostics Regulation (AMDF and related)

Continental and global initiatives supporting regulation of medical devices and in-vitro diagnostics (IVDs), including AMDF technical outputs and reference standards.

Web Page Africa Medical Devices Forum (AMDF) Access →
Web Page AMDF Technical Committee Access →
Report WHO Africa – AMDF COVID-19 Report Access →
PDF IMDRF–Africa Medical Devices Report Access →
PDF AMDF Guideline: Inspection of Manufacturing Sites (French draft) Access →
PDF AMDF Guideline: Registration of Medical Device Establishments (English draft) Access →
PDF AMDF Guideline: Enregistrement des établissements (French draft) Access →
PDF AMDF Guideline: Importation & Exportation of Medical Devices (English draft) Access →
PDF AMDF Guideline: Importation/Exportation de dispositifs médicaux (French draft) Access →
PDF AMDF: Specific Considerations for Regulating MNCH Medical Devices (Market Authorisation) Access →

Vaccines, Clinical Trials & Regulatory Preparedness (AVAREF and related)

Resources supporting harmonised oversight of vaccines, clinical trials, emergency preparedness and joint regulatory reviews, including AVAREF guidance.

Web Page AVAREF Overview (WHO AFRO) Access →
Guidelines AVAREF Guidelines Access →
Web Page AVAREF Technical Committee (AMRH) Access →
Publication AVAREF Strategy & Emergency Preparedness Access →

Medicines Quality, Pharmacovigilance & Surveillance (AMQF and related)

Resources supporting medicines quality assurance, pharmacovigilance, post-market surveillance and combating substandard/falsified medical products.

Web Page African Medicines Quality Forum (AMQF-TC) Access →
PDF AMQF Pharmaceutical Laboratory Equipment Management Guideline (PDF, 2024) Access →
Web Page USP PQM+ – AMQF Overview Access →
Web Page EDQM–Africa Regulatory Strengthening Access →

WHO & Global Benchmarking / Reliance Reference Materials

WHO global benchmarking tools, regulatory reliance references and international guidance frequently used by African NRAs and regional initiatives.

Web Page WHO Global Benchmarking Tool (GBT) Access →
Web Page WHO: Global Benchmarking Tools (GBT) – landing Access →
Web Page AVAREF – WHO AFRO Overview (FR/EN) Access →
Web Page WHO Regional Work-Sharing & Joint Reviews Access →
Web Page WHO: Regional joint activities and work-sharing – landing Access →
Web Page WHO Maturity Level 3 Achievements (Africa) Access →

News & Regulatory Alerts (Africa Medicines Regulation)

News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).

Web Page NAFDAC Recalls & Safety Alerts (index page) (2025) Access →
News Article NAFDAC Public Alert No. 027/2025 – Counterfeit Postinor2 (Levonorgestrel 0.75mg) (2025) Access →
News Article NAFDAC Public Alert No. 21/2025 – Unregistered Tarivid (Ofloxacin 200mg) (2025) Access →
News Article NAFDAC Public Alert No. 17/2025 – Falsified Healmoxy Capsules 500mg (2025) Access →
News Article NAFDAC Public Alert No. 13/2025 – Counterfeit Accu-Chek Instant Test Strips (2025) Access →
News Article NAFDAC Public Alert No. 11/2025 – Recall by Sun Pharma/Glenmark/Zydus (2025) Access →
News Article NAFDAC Public Alert No. 010/2025 – Fake “Wonder Calcium” product (2025) Access →
Press Release NAFDAC Public Alert No. 09/2025 – Voluntary recall of Zovirax IV infusion (GSK) (2025) Access →
News Article NAFDAC Public Alert No. 07/2025 – Falsified OXYCONTIN 80mg (WHO European Region) (2025) Access →
News Article NAFDAC Public Alert No. 05/2025 – Falsified Cikatem with falsified NRN (2025) Access →
Press Release NAFDAC (Notice) – Blacklisting Aveo + banning Tapentadol/Carisoprodol combinations (2025) Access →
News Article NAFDAC Public Alert No. 04/2025 – Illegal exportation/sale of opioids (Aveo) (2025) Access →
News Article NAFDAC Public Alert No. 03/2025 – Counterfeit/Falsified Petsow Starnicillin 500mg (2025) Access →
Press Release NAFDAC Public Alert No. 01/2025 – Discontinued registration of multi-dose Artemether/Lumefantrine dry powder (2025) Access →
Press Release MCAZ – MEDIA RELEASE: Class II Recall of Captopril 25mg Tablets (2025) Access →
PDF MCAZ – Notice: Lenacapavir 463.5mg/1.5ml Injection (Sunlenca) (2025) Access →
Press Release MCAZ – Warning: Adulterated HONEY with Sildenafil/Tadalafil (2025) Access →
Press Release MCAZ – Warning: “Handy Heroes” (adulterated product alert) (2025) Access →
PDF MCAZ – MoU: Zambia Medicines Regulatory Authority (ZAMRA) (2025) Access →
Web Page TMDA Announcement – Payment of Annual Retention Fees for the Year 2024 (2024) Access →
Press Release TMDA Public Notice – Quality testing of Glycerin 99.5% USP at TMDA lab (2022) Access →
Press Release TMDA Public Notice – COVID-19 Vaccine Emergency Use Authorization (EUA) (2021) Access →
Press Release TMDA Public Notice – Foreign customers for premises: requirements and procedures (2020) Access →
Press Release TMDA Public Notice – Tobacco smoking public health warning (2021) Access →
Press Release TMDA Public Notice – Shifting of Authority Functions (2019) Access →
News Article TMDA Public Notice – Expression of Interest: Evaluators of Medicinal Products and Medical Devices (2024) Access →
News Article WHO AFRO – Africa sets course for affordable, quality medicines with new 10-year roadmap (2025) Access →
News Article WHO AFRO (Namibia) – Regulatory strengthening through WHO-assisted self-benchmarking (2025) Access →
News Article WHO AFRO (Angola) – Strengthening regulation of medicines and health technologies (2025) Access →
Press Release African Union – AMA Treaty enters into force (Press Release) (2021) Access →
News Article AMRH – Call for industry applications: Pilot of continental listing of medicinal products (2025) Access →
News Article AMRH – Call for industry applications: Mpox candidate medicinal products (expedited evaluation) (2025) Access →
News Article AMRH – Invitation of Expression of Interest: Mpox diagnostic IVD manufacturers/developers (2025) Access →
Web Page WHO – Global Benchmarking Tools (GBT) page (reference used in NRA strengthening news) (ongoing) Access →
Web Page TMDA Publications Index – Medicines Registration Guidelines listing (reference point) (ongoing) Access →
Web Page ZA Zi Bo Na – Home / notices (regional work-sharing updates) (ongoing) Access →
Web Page ZA Zi Bo Na – FAQs (ongoing) Access →
Web Page WHO – Regional joint activities and work-sharing (reference) (ongoing) Access →
Web Page EAC – MRH programme page (regional collaboration updates) (ongoing) Access →
Web Page EAC – EAC-MRH document repository (regional documents/news) (ongoing) Access →
Web Page AU – AMA Treaty official page (key reference) (ongoing) Access →
Web Page EMA – Cooperation overview with African Medicines Agency (AMA) (reference) (ongoing) Access →
Web Page WHO AFRO – Essential medicines topic page (featured news entry point; multi-language) (ongoing) Access →
Portal AMRH – Programme portal (news + publications entry point) (ongoing) Access →
Portal MCAZ – Portal home (publications/press release entry point) (ongoing) Access →
Web Page NAFDAC – Recalls & Safety Alerts category root (ongoing) Access →
Web Page TMDA – Announcements index (ongoing) Access →
Web Page WHO AFRO – Featured news index (multi-language) (ongoing) Access →
Web Page AMRH – Resources page (reference entry point) (ongoing) Access →
Web Page ZA Zi Bo Na – Guidelines index (regional technical updates) (ongoing) Access →

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National Regulatory Authorities (NRAs) – Country Guidance & Publications

National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).

Portal AMRH Programme Portal Access →
Publication Nature – African Medicines Agency Analysis Access →
Web Page EMP-TC Continental Procedure (AMRH publication page) Access →
PDF Applicants: Biotherapeutic Products (EMP-TC guidance PDF) Access →
PDF CTD Product Dossier Guideline (PDF) Access →
Web Page PPB Guidelines download portal Access →
PDF Marketing Authorisation: Procedural Aspects (Human Pharma) (PDF) Access →
Web Page TMDA Medicines Registration Guidelines listing (portal page) Access →
PDF SAHPRA GMP Guideline (PDF, 2022) Access →
Publication EAC Joint Assessment performance paper (ScienceDirect, 2023) Access →
PDF 1st Biennial Scientific Conference book of abstracts (PDF) Access →
PDF Pharmaceutical Manufacturing Plan for Africa (PMPA) Business Plan (PDF) Access →
Web Page AMRH Tanzania profile (PMS/regulatory context) Access →
Portal Morocco AMMPS – Official Portal (FR) Access →
Web Page AMRH Resource Hub Access →
Publication PLOS Global Public Health – AMA Readiness Access →
PDF EMP-TC Guidelines on Procedural Aspects for Submission (PDF) Access →
PDF Applicants: Biosimilar Products (EMP-TC guidance PDF) Access →
PDF CTD Table of Contents (Modules 2–5) (PDF) Access →
Publication Compendium: Medicines Evaluation & Registration (PPB) Access →
PDF Renewal of Registered Human Pharma Products (PDF) Access →
PDF Compendium: Marketing Authorisation of Medicinal Products (PDF, July 2020) Access →
PDF MCA (Gambia) – Renewal of Marketing Authorisation Guideline (PDF, 2025) Access →
PDF EAC MRH effectiveness/efficiency evaluation (Ngum et al., 2022 PDF) Access →
Report 2nd Biennial Scientific Conference report (PDF) Access →
Web Page AMMPS – New AMM Guidelines Announcement (FR) Access →
Web Page Regional Centres of Regulatory Excellence (RCOREs) Access →
Publication BMJ Global Health – Regulatory Harmonisation Access →
Guidelines Guidance: Eligibility Criteria for Priority Products (AMRH) Access →
PDF Brand Names: Guidance for Applicants (EMP-TC PDF) Access →
PDF Guidelines: Registration of Drug Products Made in Nigeria (2025 PDF) Access →
Guidelines Premises Registration & Licensing Guidelines (PPB) Access →
PDF Rwanda medicines registration regulation draft (PDF) Access →
Web Page Procedures for Marketing Authorisation (web page) Access →
Publication ZaZiBoNa work-sharing analysis (PMC full text, 2025) Access →
Report 3rd Biennial Scientific Conference report (PDF, 2017) Access →
Portal Senegal ARP – Official Portal (FR) Access →
Publication RCOREs Overview Publication Access →
PDF World Bank – Medicines Regulation in Africa Access →
PDF Continental Regulatory Reliance Framework (PDF, 2025) Access →
PDF Guidelines: Registration of Imported Drug Products (2025 PDF) Access →
PDF PPB Drug registration application form (PDF) Access →
Web Page Rwanda FDA enabling law (RwandaLII) Access →
PDF Guidelines: Variations on Registered Medicinal Products (PDF) Access →
Publication ZaZiBoNa milestone paper (Taylor & Francis, 2025) Access →
PDF ARP Senegal – AMM Modalities Guideline (FR PDF) Access →
Web Page Call: Pilot of Continental Listing of Medicinal Products (AMRH) Access →
PDF Vaccines: CTD Submission Guidance (PDF) Access →
PDF PPB Drug registration guideline (PDF copy) Access →
PDF Import/Export authorisation regulations (Rwanda FDA file) Access →
PDF Guidelines: Labelling Format/Content for Medicinal Products (PDF) Access →
Publication ZaZiBoNa effectiveness & efficiency (ResearchGate entry) Access →
Portal Côte d’Ivoire AIRP – Official Portal (FR) Access →
Web Page Call: Mpox Candidate Medicinal Products – Expedited Evaluation Access →
PDF Legacy local registration guideline (PDF) Access →
PDF Clinical Trials Guidelines in Kenya (PDF) Access →
PDF Guidelines: Import/Export of Pharma Products & Raw Materials (PDF) Access →
PDF Evaluating success of ZaZiBoNa (Dissertation/PDF, 2020) Access →
Web Page Call: Mpox Diagnostic IVD Manufacturers/Developers (EOI) Access →
PDF Kenya health products registration rules (Legal Notice, PDF) Access →
PDF Medical Device Registration Guidelines (PDF, 2016) Access →
Publication EAC joint assessment procedure paper (ResearchGate record) Access →
PDF Medical Devices Regulations (PDF, 2015) Access →
Publication TMDA GMP inspections study (PMC full text, 2024) Access →
PDF Guidelines: Import/Export of Medical Devices incl. IVDs (PDF, 2020) Access →
PDF Compendium: Devices/Diagnostics/Lab Equipment (PDF, June 2024) Access →
PDF Ghana FDA: Guideline on Registration of Allopathic Drugs (PDF) Access →
Web Page TMDA: Medical Devices marketing authorisation procedures Access →
Web Page TMDA: Registration/licensing of premises (web page) Access →
PDF TMDA: Regulatory Reliance for Marketing Authorisation (PDF, July 2025) Access →
PDF TMDA MAGHP experience (Swissmedic webinar PDF) Access →
PDF Zimbabwe MCAZ: Guideline on submission of documentation (CTD Quality) for multisource FPP (PDF) Access →
PDF Zambia ZAMRA: CTD Marketing Authorisation Guidance (Quality part) (PDF) Access →
PDF Zambia ZAMRA: Guideline on Establishment of a Pharmaceutical Retail Business (Amendment) (PDF) Access →
Web Page Malawi PMRA: Guidelines Portal (landing page) Access →
PDF Malawi PMRA: Fast Track Registration Guideline (PDF) Access →

120

News & Media – Medicines Regulation in Africa

Media and press coverage on AMA, AMRH and national regulation

Web Page Medias24 (FR) – Morocco publishes new medicines guidelines Access →
Web Page AP News – African Medicines Agency public health priorities Access →
Web Page Le Monde Afrique – Côte d’Ivoire enforcement action (FR) Access →