Ethiopia has been formally recognized by the World Health Organization (WHO) for achieving Maturity Level 3, placing it 9th country in Africa, 3rd in East Africa amd the 1st in IGAD region to achieve this major milestone. EARAPA 1st October 2025
Ethiopia joins Egypt, Ghana, Nigeria, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda in reaching ML3 on the continent. WHO said in its official press release yesterday, 30th September 2025 that, […]
We are thrilled to announce our partnership as an association partner for the PharmaRegAfriSummit 2025, the top engaing pharmaceutical regulatory submit of the continent happening November 2-3, 2025 in Cairo, Egypt!
This premier event brings regulatory experts and industry key palyers lfrom all over Africa togetherand beyond whoch makes an excellent opportunities for the regulatory updates of NRAs and regional procedures. […]
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, EMA, Roche, Bayer, Shiongi Europe, […]
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 […]
Ghana 🇬đź‡, 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 following a […]
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 AnneRegulatory Officer, Department of Product Evaluation and Registration Pharmacy and Poisons Board(PPB), Kenya has a short interview with EARAPA youtube. Stay Tunned, it will be released soonhashtag#SUBSCRIBE […]
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. These approvals were based on rigorous scientific […]