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Nigeria's medicines regulator. It registers medicines, including cancer medicines, can rely on an approval by a stringent foreign regulator to shorten its review, and holds the World Health Organization's maturity level 3 rating for medicines and vaccines.
NAFDAC was established by Decree No. 15 of 1993, now the NAFDAC Act Cap N1 Laws of the Federation of Nigeria 2004, to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices and other regulated products. Its corporate headquarters is at Plot 2032, Olusegun Obasanjo Way, Zone 7, Wuse, Abuja; the coordinates are a point on that street, not the building.
Its reliance guideline (DR&R-GDL-035-00, effective 10 September 2024) lets it register a drug, vaccine or in vitro diagnostic already approved by a stringent regulatory authority as the World Health Organization defines it through an abridged assessment, using that authority's assessment reports and its inspection reports (no more than three years old) while keeping its own decision. The guideline states that NAFDAC will decide on registration within 60 working days (about 90 calendar days); it also allows NAFDAC to rely on analytical reports from quality control laboratories in such countries and still to test products itself.
The Presidency reported in August 2025 that NAFDAC kept the World Health Organization's maturity level 3 status for regulating medicines and vaccines (non-producing) after a re-benchmarking from 28 to 30 May 2025, a level it first reached in 2022 as the first African national regulator to do so in that category. NAFDAC's Director General sits on the National Health Technology Assessment Steering Committee inaugurated in September 2026.
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