Search across 69,000+ products, devices, trials, documents, and organizations
| Type | Title & Description | Details | Country | Status |
|---|---|---|---|---|
| Resource |
East African Community (EAC-MRH) - Documents
Regional work-sharing / joint assessment procedures and harmonisation mechanisms implemented by RECs and regional initiatives (EAC-MRH, ECOWAS/WAHO, Z...
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Cat: Regional Harmonisation Mechanisms (RECs & Regional Initiatives)
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| Resource |
EAC-MRH Document Repository (category page)
Regional work-sharing / joint assessment procedures and harmonisation mechanisms implemented by RECs and regional initiatives (EAC-MRH, ECOWAS/WAHO, Z...
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Cat: Regional Harmonisation Mechanisms (RECs & Regional Initiatives)
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| Resource |
EAC – EAC-MRH document repository (regional documents/news) (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 |
Zimbabwe MCAZ: Guideline on submission of documentation (CTD Quality) for multisource FPP (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 |
AMA Infographic (English – alternate AU copy)
Official AU and partner resources on the establishment, treaty instruments, institutional framework, operationalisation and cooperation arrangements o...
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Cat: African Medicines Agency (AMA) – Treaty, Legal & Institutional
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| Resource |
AMA FAQs
Official AU and partner resources on the establishment, treaty instruments, institutional framework, operationalisation and cooperation arrangements o...
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Cat: African Medicines Agency (AMA) – Treaty, Legal & Institutional
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| Resource |
AU AMA Infographics landing page
Official AU and partner resources on the establishment, treaty instruments, institutional framework, operationalisation and cooperation arrangements o...
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Cat: African Medicines Agency (AMA) – Treaty, Legal & Institutional
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| Resource |
AMA Institutional Framework
Official AU and partner resources on the establishment, treaty instruments, institutional framework, operationalisation and cooperation arrangements o...
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Cat: African Medicines Agency (AMA) – Treaty, Legal & Institutional
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| Resource |
AMA Business Plan (Draft)
Official AU and partner resources on the establishment, treaty instruments, institutional framework, operationalisation and cooperation arrangements o...
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Cat: African Medicines Agency (AMA) – Treaty, Legal & Institutional
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| Resource |
AMA Legal Framework
Official AU and partner resources on the establishment, treaty instruments, institutional framework, operationalisation and cooperation arrangements o...
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Cat: African Medicines Agency (AMA) – Treaty, Legal & Institutional
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| Resource |
IMDRF: Principles of Labelling for Medical Devices & IVDs (Edition 2, 2024)
International Medical Device Regulators Forum standards frequently referenced by African NRAs.
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Cat: Global Standards & IMDRF
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| 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 |
ECOWAS Joint Assessment Procedure (Edited)
Regional work-sharing / joint assessment procedures and harmonisation mechanisms implemented by RECs and regional initiatives (EAC-MRH, ECOWAS/WAHO, Z...
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Cat: Regional Harmonisation Mechanisms (RECs & Regional Initiatives)
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| Resource |
1st Biennial Scientific Conference book of abstracts (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 |
Pharmaceutical Manufacturing Plan for Africa (PMPA) Business Plan (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 |
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 |
World Bank – Medicines Regulation in Africa
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 |
Vaccines: CTD Submission 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 |
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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