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Drug Evaluation and Research Directorate (DER) of BMPOHS was created out of the defunct Establishment Inspection Directorate (EID) in March, 2013 occasioned by need for refocusing, specialization and research. The focus of the Directorate is on Good Manufacturing Practice, Good Clinical Practice and Good Storage Practices. Our scope covers regulation of pharmaceutical, herbal medicines, cosmetics, biopharmaceuticals, medical devices and clinical trial facilities locally and internationally. The Directorate comprises of Six (6) Divisions namely: Clinical Trials & Drugs, Cosmetics & Medical Devices, Pharmaceutical Compliance, Herbal Medicines & Nutraceuticals, Vaccines & Biologics and Quality Management System (QMS). The Directorate is headed by a Director resident at the headquarters and has a pool of highly skilled and experienced staff comprising of management, regulatory and administrative cadres.
Food Safety and Applied Nutrition (FSAN) Directorate is to take all steps to ensure that food manufactured, imported, exported, distributed, sold, advertised and used in Benin meet the highest standard of Food Safety reasonably achievable. The Directorate has put in place a framework to key into International best practices to align with the Agency’s vision to remain among the top 18 Regulatory Agencies of the world.
A small river named Duden flows by their place and supplies it with the necessary regelialia. It is a paradisematic country, in which roasted parts of sentences fly into your mouth.
Pharmacovigilance/Post Marketing Surveillance(PV/PMS) Directorate is one of the technical Directorates of the Agency. It operates from the BENIN/FDA Corporate Headquarters Porto Novo, and PV/PMS office Cotonou. It has presence in the six (6) Zonal Offices and in the State Offices.
The Regulatory Affairs (RA) Division has the statutory function of drafting and processing the Regulations. The Quality Management System (QMS), Thematic Working Group (TWG) and Immersion activities are domiciled here. The Division comprises of two (2) Units; Regulations (RU) and Good Regulatory Practice (GRP) Units. The Advertisement Control (AC) Division is responsible for the regulation and control of advertisements of foods, drugs, cosmetics, medical devices, packaged water, chemicals and detergents. There are three (3) Units in the Division namely; Drugs, Biologics, Vaccine and Medical Devices Unit, Food Unit and the Cosmetics Unit. Imported Drugs (ID) Division is responsible for the registration of all imported Drugs. It comprises of two Units; Unit 1 (China, Europe, Other Asian countries and Africa), Unit II (India, The Americas and Australia).