President Bola Tinubu has congratulated the National Agency for Food and Drug Administration and Control (NAFDAC) on retaining the World Health Organisation’s (WHO) Maturity Level 3 (ML3) status for regulating medicines and vaccines.
The president’s message followed a WHO re-benchmarking exercise conducted in May, which assessed NAFDAC’s performance against globally recognised regulatory standards.
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NAFDAC first achieved the ML3 status in 2022, becoming the “first National Regulatory Authority in Africa” to reach that milestone for the regulation of medicines and vaccines in a non-producing country. The WHO conducts periodic reviews to ensure that agencies maintain the required standards.
The latest evaluation followed a formal re-benchmarking in November 2024 and five Institutional Development Plan (IDP) review meetings between February and April 2025 to assess progress on corrective actions.
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Mr Tinubu acknowledged in a statement signed on Monday by his Special Adviser on Information and Strategy, Bayo Onanuga, that WHO concluded in its verdict that NAFDAC continues to operate a stable, well-functioning, and integrated framework for regulating medicines and vaccines.
“This achievement results from investment by the Government of Nigeria in strengthening the regulatory system,” it noted.
What ML3 rating means
The WHO’s Maturity Level three rating is part of its Global Benchmarking Tool (GBT), which assesses the capacity of national regulatory authorities to regulate medical products.
The scale ranges from Level one, where only some elements of a regulatory system exist, to Level four, representing advanced performance and continuous improvement.
Nigeria’s ML3 status applies to both locally produced and imported medicines and vaccines. It means that NAFDAC has a stable, well-functioning, and integrated regulatory system, making it eligible for inclusion in the transitional WHO Listed Authorities (WLA).
The WLA is a list of global regulators recognised as meeting WHO and other international standards.
In Africa, only Tanzania, Ghana, Nigeria, and Egypt currently hold ML3 status. The WHO benchmarks agencies against 268 sub-indicators covering areas such as clinical trial oversight, marketing authorisation, vigilance, laboratory testing, inspection, and market surveillance.
According to NAFDAC, Nigeria was evaluated in eight out of nine functions, with the “lot release” function applicable only to vaccine-producing nations.
Presidential commendation
Mr Tinubu praised NAFDAC’s management and staff for their professionalism, consistency, and dedication to safeguarding public health.
He said the achievement strengthens Nigeria’s standing as a reliable partner in global health security and pandemic preparedness.
He reaffirmed his administration’s commitment to ensuring the safety, quality, and efficacy of medicines and vaccines in line with international best practices.
The president noted that this milestone supports his Renewed Hope Agenda to transform Nigeria’s healthcare system.
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According to the statement, the administration has made progress in upgrading over 17,000 primary health centres, improving maternal care and diagnostics in underserved communities, training 120,000 frontline health workers, and working to double national health insurance coverage within three years.
The president also emphasised the importance of promoting local production of healthcare products, pledging continued collaboration with credible partners, development agencies, and donor organisations to grow Nigeria’s pharmaceutical sector, attract investment, and expand local manufacturing capacity.
He assured that his administration will support NAFDAC’s efforts to attain WHO’s Maturity Level four, the highest global standard of regulatory excellence.
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