Nigeria has maintained its World Health Organisation (WHO) Maturity Level 3 (ML3) status for the regulation of medicines and vaccines, following a recent re-benchmarking exercise that confirmed the country’s adherence to global regulatory standards.
The National Agency for Food and Drug Administration and Control (NAFDAC) secured the renewed rating after a WHO assessment conducted between May 28 and May 30, 2025.
The evaluation examined the agency’s performance against international benchmarks, following an earlier formal re-benchmarking in November 2024 and five Institutional Development Plan review meetings held between February and April 2025.
NAFDAC first achieved ML3 status in 2022, making Nigeria the first African nation without domestic vaccine production to reach this milestone.
The status signifies a stable, well-functioning, and integrated regulatory system for medicines and vaccines, in line with WHO requirements.
The renewed ranking reflects ongoing government investments in strengthening Nigeria’s pharmaceutical regulatory framework. It also reinforces the country’s standing in global health security and pandemic preparedness.
President Bola Tinubu commended NAFDAC’s management and staff for their professionalism and consistency, describing the achievement as a major boost to the nation’s healthcare credibility.
He highlighted ongoing health sector reforms, including the upgrade of over 17,000 primary healthcare centres nationwide, improved maternal and diagnostic services in underserved areas, training of 120,000 frontline health workers, and plans to double national health insurance coverage within three years.
Tinubu also reaffirmed his administration’s commitment to advancing Nigeria’s pharmaceutical industry by collaborating with development partners and investors, expanding local manufacturing capacity, and supporting NAFDAC’s progression towards WHO’s highest regulatory level, Maturity Level 4.
