LAGOS, Nigeria(VOICE OF NAIJA)- Nigeria has set a new benchmark in Africa’s health sector, becoming the first country on the continent to sustain the World Health Organization’s (WHO), prestigious Maturity Level 3 (ML3) status for the regulation of medicines and vaccines.
The achievement, announced on Tuesday, cements the nation’s role as a trusted hub for pharmaceutical oversight and positions it for greater global trade in medical products.
ML3 certification is a critical prerequisite for vaccine manufacturing and a powerful endorsement of a country’s regulatory strength.
While Tanzania, Ghana, Egypt, Rwanda, Senegal, and Zimbabwe have each attained ML3 in recent years, Nigeria now stands apart as the only African nation to maintain it.
The recognition, valid until June 30, 2025, follows WHO-led assessments in Abuja and Lagos in late 2024, as well as five follow-up Institutional Development Plan meetings between February and May 2025.
Speaking in Abuja, National Agency for Food and Drug Administration and Control (NAFDAC) Director General, Prof. Mojisola Adeyeye, revealed that the evaluation reviewed over 260 sub-indicators and addressed more than 800 recommendations from the previous 2022 assessment
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“The successful closure of all critical recommendations reaffirms Nigeria’s stable and integrated regulatory system,” she said, noting that WHO examined nine key regulatory functions, including market authorization, market control, laboratory testing, and inspection standards.
The collaborative effort between NAFDAC and the Pharmacy Council of Nigeria (PCN) proved essential, ensuring rigorous licensing processes, manufacturing oversight, and coordinated inspections.
PCN Registrar and CEO, Babashehu Ahmed, emphasized that this partnership extends to their joint leadership of the Federal Task Force to combat substandard medicines and unsafe food.
With 27 of the 57 Maturity Level 4 indicators already closed, Nigeria is now working toward achieving WHO’s highest validation tier and securing WHO-Listed Authority recognition.
Notably, this next milestone would further ease global market access for Nigerian-approved products while boosting investor confidence.
“This is more than a regulatory victory. It will attract investment, create jobs, and advance Nigeria’s universal health coverage goals. Our mission is to protect public health while making Nigeria a global leader in pharmaceutical excellence,” Ahmed stressed.
By sustaining WHO’s ML3 status, Nigeria has not only secured its place in Africa’s regulatory history but also opened a door to a future where the country’s medicines and vaccines can stand shoulder to shoulder with the world’s best.
