Nigeria

Nigeria regulates pharmaceutical products through the National Agency for Food and Drug Administration and Control (NAFDAC), established by Decree 15 of 1993 (now NAFDAC Act, Cap N1, LFN 2004). NAFDAC is the lead authority for the registration, manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, packaged water and chemicals. The Drug Evaluation and Research (DER) Directorate handles human medicines. Marketing authorisation is evidenced by a NAFDAC Certificate of Registration, valid for 5 years. NAFDAC achieved WHO Maturity Level 3 (ML3) for vaccines in 2024 — among the first in Africa — and is working towards ML3 for medicines. NAFDAC operates Standard, Reliance / Abridged and Emergency Use Listing (EUL) pathways, with formal recognition of Stringent Regulatory Authorities and WHO Prequalification under its Reliance Guidelines (2022). Nigeria is an active participant in the African Medicines Regulatory Harmonisation (AMRH) initiative, the West African Health Organization (WAHO) ECOWAS Medicines Regulatory Harmonisation (ECOWAS-MRH) and the African Medicines Agency (AMA) treaty. Public-sector access runs through the National Health Insurance Authority (NHIA, replacing the former NHIS under Act No. 17 of 2022), the Federal Ministry of Health and state-level procurement, with significant contributions from donor-funded programmes (Global Fund, PEPFAR, GAVI). Pricing is largely market-driven, with no comprehensive national price control for innovator products outside donor-funded essential medicines.