Regulatory news from across Africa
EARAPA announcements, regulatory developments and Regulatory Spotlight interviews.
We are thrilled to announce our partnership with the Global Pharmaceutical Regulatory Affairs Summit happening October 21-23, 2025 in Berlin, Germany!
This premier event brings together regulatory affairs leaders to tackle the industry’s most pressing challenges. Our exceptional speaker lineup includes regulatory experts from Daiichi Sankyo,…
5 posts in News
National Agency for Drug Administration and control (NAFDAC) declared to be the first African Agency to achieve and sustain WHO maturity level 3 in medicine and Vaccine regulation in Africa. EARAPA 7th August 2025
The agency expressed it as a proud moment for Nigeria and NAFDAC to share that the World Health Organization has officially confirmed, NAFDAC has maintained Maturity Level 3 (ML3) for the…
Ghana 🇬🇭, Food and Drugs Authority recalled over 700,000 bottles of carvedilol tablets manufactured by New Jersey-based Glenmark Pharmaceuticals Inc. due to the presence of N-Nitroso Carvedilol I impurity. EARAPA 1st August 2025
According to medicines for africa (mfa) reports, the recall was due to the presence of N-Nitroso Carvedilol I impurity, a cancer-causing impurity, above the recommended acceptable intake limit…
EARAPA Regulatory Spotlight 41. what is the average medicine registration timeline in PPB, Kenya?2. What do you advise applicants to shorten the medicine registration timeline in the kenyan system ?
Dr. Tibin Ngeiywa Anne Regulatory Officer, Department of Product Evaluation and Registration Pharmacy and Poisons Board(PPB), Kenya has a short interview with EARAPA youtube.
AMRH Steering Committee Approves Five Additional Human Medicinal Products for Continental Listing, 2nd edition of Green book is released today; EARAPA 18 July 2025
The African Medicines Regulatory Harmonisation (AMRH) Steering Committee has approved five additional medicinal products for Continental Listing during its 17–18 July 2025 session.
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