Nigeria Cements African Leadership in Health Regulation as First to Sustain WHO ML3

The National Agency for Food and Drug Administration and Control (NAFDAC) and the Pharmacy Council of Nigeria (PCN) have achieved a historic milestone by becoming the first African nations to retain the World Health Organization’s (WHO) Maturity Level 3 (ML3) status for the regulation of medicines and vaccines.

The status, effective from 30 June 2025, reaffirms Nigeria’s position among countries with stable, well-functioning regulatory systems—a critical requirement for local vaccine production.

The announcement was made in Abuja by NAFDAC Director-General Prof. Mojisola Adeyeye during a joint press briefing with PCN Registrar Pharm. Ibrahim Ahmed.

The retention follows a rigorous re-benchmarking exercise conducted by WHO in Abuja and Lagos between 25 and 29 November 2024, supplemented by five follow-up Institutional Development Plan (IDP) meetings from February to May 2025.

“This achievement confirms Nigeria as the first National Regulatory Authority (NRA) in Africa not only to attain but also sustain ML3 status,” said Prof. Adeyeye. “All critical recommendations from the previous evaluation have now been fully addressed.”

The ML3 compliance requires meeting approximately 260 sub-indicators and over 800 recommendations, ensuring robust public health safeguards. Sustaining this status strengthens Nigeria’s pathway to Maturity Level 4 (ML4)—the WHO’s highest regulatory classification—which would grant the country WHO-Listed Authority (WLA) status.

Prof. Adeyeye described the feat as a “Renewed Hope milestone” in Nigeria’s pursuit of universal health coverage, crediting NAFDAC and PCN staff for their dedication. She also acknowledged President Bola Ahmed Tinubu and the National Security Adviser for their “unwavering support,” stating that the recognition reflects Nigeria’s growing capacity to meet global health standards.

If Nigeria achieves ML4, NAFDAC-approved medical products could enter international markets without additional regulatory barriers—boosting pharmaceutical exports and investor confidence.

The WHO’s validation underscores Nigeria’s readiness to support local vaccine manufacturing while safeguarding public health. Prof. Adeyeye emphasised that this success “protects the well-being of citizens” and positions Nigeria as a continental leader in health regulation.

With this retention, Nigeria moves closer to joining an elite group of globally recognised regulatory authorities, setting a precedent for other African nations.