The World Health Organization (WHO) has confirmed Nigeria’s sustained attainment of Maturity Level 3 (ML3) in the regulation of medicines and vaccines.
Gatekeepers News reports that in a statement signed by its Director General, Prof. Mojisola Adeyeye, on Thursday, the National Agency for Food and Drug Administration and Control (NAFDAC) announced that the ML3 status was sustained as of June 30, 2025, following a series of rigorous assessments by WHO.
The re-validation process included a formal re-benchmarking exercise conducted in Abuja and Lagos from November 25 to 29, 2024, alongside five follow-up institutional development plan (IDP) meetings held between February and May 2025. These sessions were designed to assess the agency’s progress in addressing key regulatory recommendations.
According to the agency, the successful closure of all critical recommendations confirms that Nigeria continues to operate a stable, well-functioning, and integrated regulatory system for medicines and vaccines.
With this development, Nigeria remains the first and only National Regulatory Authority (NRA) in Africa to achieve and maintain the WHO’s ML3 status.
This level is considered a significant step toward the WHO listing of vaccines and medicines produced in the country for international procurement.
Adeyeye expressed NAFDAC’s pride in being the first National Regulatory Authority (NRA) in Africa to maintain WHO ML3 status, underscoring the Agency’s leadership and excellence in regulatory oversight on the continent.
She described the achievement as a result of “unwavering dedication, technical expertise, and resilience” of staff across the country.
The DG reaffirmed the agency’s dedication to improving regulatory standards, safeguarding public health, and strengthening Nigeria’s position in the global health landscape.
