The National Agency for Food and Drug Administration and Control (NAFDAC) is pleased to announce that the World Health Organization (WHO) has officially reaffirmed Nigeria’s achievement of Maturity Level 3 (ML3) for the regulation of medicines and vaccines, effective 30th June 2025.
This recognition followed WHO’s formal re-benchmarking exercise conducted in Abuja and Lagos from 25th to 29th November 2024, alongside five follow-up Institutional Development Plan (IDP) meetings held between February and May 2025.
These sessions reviewed the progress made by NAFDAC and the Pharmacists Council of Nigeria (PCN) in implementing key recommendations necessary to successfully complete the re-benchmarking process.
The closure of all critical recommendations marks a major regulatory milestone for Nigeria, reaffirming that NAFDAC operates a stable, well-functioning, and integrated regulatory system for medicines and vaccines.
Notably, NAFDAC and PCN remain the first National Regulatory Authority (NRA) in Africa to sustain WHO’s ML3 status, underscoring the Agency’s leadership and excellence in regulatory oversight across the continent.
This achievement reflects the unwavering dedication, technical expertise, and resilience of all NAFDAC staff nationwide and that of our partners at the PCN, whose collective efforts have positioned Nigeria as a model for regulatory excellence in Africa.
ML3: Has about 260 sub-indicators and over 800 recommendations.
Maturity Level for a country to have to be able to manufacture vaccine
ML3 Re-benchmarking: Compulsory audit to ensure regulatory agency has maintained or is maintaining the standards
ML4: Has 57 indicators: Closed 27 indicators; 30 indicators remaining
WLA: WHO listed Authorities – New description for Stringent Regulatory Authorities
Assessment based on evidence-based performance audit
Enables local manufacturers to trade products approved by NAFDAC post that date worldwide
Great for Nigeria’s public health and the confidence level of the consumers in NAFDAC-approved medical products
A boost for the image of Nigeria and the economy,
Reduces unemployment
A Renewed Hope outcome in the health care system and universal health coverage
