President Bola Tinubu has commended 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 in Nigeria.
According to NAFDAC, Nigeria was evaluated in eight out of nine functions, with the “lot release” function applicable only to vaccine-producing nations.
The president’s commendation conveyed in a statement issued on Monday by his Special Adviser on Information and Strategy, Bayo Onanuga, was sequel to the global health orgniasation’s re-benchmarking exercise conducted in May this year, which assessed NAFDAC’s performance against globally recognised regulatory standards.
Noting that WHO concluded in its verdict that NAFDAC continues to operate a stable, well-functioning, and integrated framework for regulating medicines and vaccines, Tinubu praised NAFDAC’s management and staff for their professionalism, consistency, and dedication to safeguarding public health.
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The President further maintained that the achievement strengthens Nigeria’s standing as a reliable partner in global health security and pandemic preparedness and restated his administration’s commitment to ensuring the safety, quality, and efficacy of medicines and vaccines in line with international best practices.
This is even as he emphasised the importance of promoting local production of healthcare products, promising the readiness of Nigeria to continue to collaborate with credible partners, development agencies, and donor organisations to grow the nation’s pharmaceutical sector, attract investment, and expand local manufacturing capacity.
Tinubu assured that his administration would support NAFDAC’s efforts to attain WHO’s Maturity Level four, the highest global standard of regulatory excellence.
It would be recalled NAFDAC first achieved the ML3 status in 2022, becoming the “first National Regulatory Authority in Africa” to achieve the standardization milestone for the regulation of medicines and vaccines in a non-producing country.
In furtherance of its roles in the global health system, the WHO conducts periodic reviews to ensure that agencies maintain the required standards.
The latest evaluation of Nigeria 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.
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), which 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.
