NAFDAC retains WHO ML3 status, earns presidential commendation

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Tinubu

President Bola Tinubu has commended the National Agency for Food and Drug Administration and Control (NAFDAC) for successfully retaining its World Health Organization (WHO) maturity level 3 (ML3) status for the regulation of medicines and vaccines. The presidential commendation was issued on Monday in a statement by presidential spokesperson, Mr. Bayo Onanuga.

The achievement followed a rigorous re-benchmarking exercise conducted by the WHO from May 28 to 30, which affirmed that NAFDAC operates a “stable, well-functioning, and integrated framework” for drug and vaccine regulation.

NAFDAC first attained the ML3 status in 2022, becoming the first national regulatory authority in Africa to reach the milestone for the regulation of medicines and vaccines for non-producing countries. Tinubu described the achievement as a boost to Nigeria’s credibility in global health security and a testament to his administration’s commitment to strengthening the country’s healthcare system.

In line with WHO protocols, the revalidation involved periodic reviews to confirm sustained compliance with international benchmarks.
The latest evaluation followed formal re-benchmarking in November 2024 and five Institutional Development Plan (IDP) review meetings held between February and April 2025.
The president described the WHO recognition as “a reflection of the government’s significant investments in NAFDAC’s regulatory capacity.
“NAFDAC has successfully maintained a regulatory system that operates as a stable, well-functioning, and integrated framework for regulating medicines and vaccines (non-producing).”
This achievement results from investments by the Government of Nigeria in strengthening the regulatory system.”
He also commended NAFDAC’s leadership and staff for their dedication, professionalism, and commitment to protecting public health.
Tinubu said the achievement reinforces Nigeria’s credibility as a trusted player in global health security and pandemic preparedness.
‎He restated the government’s commitment to strengthening regulatory systems and ensuring safe, effective, and high-quality medicines and vaccines.
He noted that the milestone aligned with the Renewed Hope Agenda to transform Nigeria’s healthcare landscape.
‎He highlighted progress in upgrading over 17,000 primary health centers nationwide to improve healthcare access.
‎Other efforts include expanding maternal care, upgrading diagnostics in rural areas, and training 120,000 frontline health workers.
Tinubu also committed to doubling national health insurance coverage within three years to improve access to essential health services.
‎He stressed that boosting local manufacturing of medicines and medical products remains a key priority.
‎He pledged continued collaboration with development partners and donors to expand investment in Nigeria’s pharmaceutical sector.
He assured that his administration would support NAFDAC to attain WHO Maturity Level 4, the highest global regulatory standard.
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