Nigeria has reaffirmed its position as a leading health regulator in Africa, with the World Health Organization (WHO) confirming the country’s sustained Maturity Level 3 (ML3) status for the regulation of medicines and vaccines.
The National Agency for Food and Drug Administration and Control (NAFDAC) announced the milestone in a statement signed by its Director-General, Prof. Mojisola Adeyeye, on August 7, 2025.
The ML3 status, officially sustained as of June 30, 2025, means Nigeria’s regulatory system is considered “stable, well-functioning, and integrated” under WHO’s Global Benchmarking Tool (GBT).
Rigorous Assessments and Global Recognition
This achievement follows a formal WHO re-benchmarking exercise conducted in Abuja and Lagos from November 25 to 29, 2024. It was complemented by five Institutional Development Plan (IDP) meetings held between February and May 2025.
The sessions reviewed NAFDAC’s progress in implementing WHO’s key recommendations. Nigeria successfully closed all critical gaps, confirming its regulatory system meets international standards.
“This milestone affirms NAFDAC’s stable, well-integrated regulatory system,” the agency stated. “It reinforces confidence in Nigeria’s oversight of medicine and vaccine safety, quality, and efficacy.”
Nigeria remains the first and only National Regulatory Authority (NRA) in Africa to achieve and maintain WHO ML3 status.
Prof. Adeyeye praised the agency’s staff, saying, “Their efforts have made Nigeria a model for regulatory excellence in Africa.”
What This Means for Nigeria’s Health Sector
The ML3 status is a major step toward WHO listing of Nigerian-made medicines and vaccines for international procurement. It also boosts Nigeria’s credibility in global health governance and opens doors for pharmaceutical exports.
WHO said the accomplishment supports universal health coverage and the Sustainable Development Goals. Follow-up visits will be conducted within a year, and another re-benchmarking exercise is scheduled in four years to assess sustainability.
NAFDAC pledged to continue improving regulatory standards, protecting public health, and strengthening Nigeria’s role in the global health ecosystem.
Rate, Like 👍, Comment💬, share this article, Follow us on our social media handles, and Submit your own story to get featured and earn rewards!
WhatsApp Channel
Telegram Channel
