NAFDAC (Nigeria)
NAFDAC (National Agency for Food and Drug Administration and Control) is Nigeria's national regulator for human and veterinary medicines, biologicals, vaccines, medical devices, IVDs, cosmetics, packaged food, bottled water, chemicals and dietary supplements — established by Decree 15 of 1993 (now the NAFDAC Act, CAP N1, LFN 2004).
The National Agency for Food and Drug Administration and Control (NAFDAC) is Nigeria's national regulatory authority for human and veterinary medicines, biologicals, vaccines, medical devices, IVDs, cosmetics, packaged food, bottled water, chemicals and dietary supplements. NAFDAC was established by Decree 15 of 1993 (now the NAFDAC Act, CAP N1, LFN 2004) and operates under the Federal Ministry of Health from its Abuja headquarters, with laboratories in Yaba (Lagos), Agulu (Anambra) and Kaduna and offices across all 36 states.
Nigeria is Africa's largest pharmaceutical market and reached WHO Maturity Level 3 for medicines regulation in 2022. NAFDAC's Directorate of Registration and Regulatory Affairs (R&R) runs the registration function under the Drug and Related Products Registration Regulations. Reliance pathways honour approvals from FDA, EMA, MHRA, Health Canada, TGA, Swissmedic and PMDA, and NAFDAC operates a CTD-aligned dossier review for generics and biosimilars. Medical devices follow a risk-classified pathway aligned to IMDRF principles. Food, cosmetics and supplements are registered under separate directorates with distinct labelling rules.
GMP inspections of overseas manufacturers are mandatory for local registration; PIC/S / EU / FDA GMP certificates support scheduling but do not replace on-site inspection for many product classes. NAFDAC is a PIC/S applicant and participates in African Medicines Regulatory Harmonisation (AMRH). NAFDAC also runs Mobile Authentication Service (MAS) — a scratch-panel SMS anti-counterfeit scheme — and TruScan handheld analyser deployments at ports of entry. V5 Ultimate maps directly onto NAFDAC expectations — bound e-signatures, ALCOA+ batch records, deviation/CAPA workflow, and a per-country dossier pack — with the paired guide at /glossary/nigeria-nafdac.
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