By Bavoriat Clara
The National Agency for Food and Drug Administration and Control (NAFDAC) has announced that the World Health Organization (WHO) has reaffirmed Nigeria’s attainment of Maturity Level 3 (ML3) for the regulation of medicines and vaccines, effective 30 June 2025.
The confirmation followed WHO’s re-benchmarking exercise conducted in Abuja and Lagos from 25 to 29 November 2024, alongside five follow-up Institutional Development Plan 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 required to successfully complete the re-benchmarking process.
The closure of all critical recommendations marks a major regulatory milestone for Nigeria, confirming that NAFDAC operates a stable, well-functioning, and integrated regulatory system for medicines and vaccines. NAFDAC and PCN remain the first National Regulatory Authorities in Africa to sustain WHO’s ML3 status, a feat that underscores Nigeria’s leadership and excellence in regulatory oversight on the continent.
According to NAFDAC, the achievement reflects the unwavering commitment, technical expertise, and resilience of its staff across the country, as well as the dedication of its partners at PCN. Retaining ML3 status enables local manufacturers to trade NAFDAC-approved medical products globally, boosts public confidence in locally regulated medicines and vaccines, and enhances Nigeria’s standing in the international health community.
It is also a significant boost for the nation’s public health system, the economy, and employment generation, while aligning with the Federal Government’s “Renewed Hope” agenda to strengthen healthcare delivery and achieve universal health coverage.
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