By Joy Odor
Nigeria has retained its World Health Organization (WHO) Maturity Level 3 (ML3) status for the regulation of medicines and vaccines, a recognition that confirms the country’s regulatory system meets global standards for quality, safety, and effectiveness.
The National Agency for Food and Drug Administration and Control (NAFDAC) announced the achievement on June 30, 2025, following a rigorous WHO re-benchmarking exercise conducted in Abuja and Lagos from November 25 to 29, 2024.
The review was complemented by five follow-up Institutional Development Plan (IDP) meetings held between February and May 2025, which assessed the progress of NAFDAC and the Pharmacists Council of Nigeria (PCN) in closing all critical recommendations.
The reaffirmation cements Nigeria’s position as the first National Regulatory Authority (NRA) in Africa to sustain WHO’s ML3 status, underscoring the country’s leadership in medicines and vaccines regulation.
NAFDAC explained that achieving and maintaining ML3 which involves meeting about 260 sub-indicators and over 800 recommendations is a prerequisite for any country seeking to manufacture vaccines.
The status enables local manufacturers to produce and export NAFDAC-approved products to international markets, boosting public health confidence, creating jobs, and enhancing Nigeria’s global image.
“This milestone reflects the dedication, technical expertise, and resilience of NAFDAC staff nationwide, as well as our strong partnership with PCN,” the agency said, adding that the recognition will further advance universal health coverage under Nigeria’s Renewed Hope Agenda.
WHO also noted that Nigeria has made progress toward Maturity Level 4 (ML4), closing 27 of the 57 required indicators.
Achieving ML4 would move Nigeria into the category of WHO-listed Authorities, enabling even greater international recognition for its regulatory approvals.
