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
|
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| Resource |
Call: Pilot of Continental Listing of Medicinal 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
|
— | — |
| 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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