Nigeria has set its sights on joining the world’s elite in pharmaceutical regulation, after the World Health Organisation reaffirmed the country’s Maturity Level 3 (ML3) status for medicines and vaccines—a recognition achieved by only a select group of regulatory authorities.
The Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, announced the milestone in Abuja on Tuesday during a joint briefing with the Pharmacy Council of Nigeria (PCN). She revealed that Nigeria has already met 27 of the 57 benchmarks required to reach Maturity Level 4 (ML4)—the highest rating possible under WHO’s Global Benchmarking Tool.
“NAFDAC and PCN remain the first National Regulatory Authority in Africa to sustain WHO’s ML3 status,” Adeyeye said, describing the achievement as proof of Nigeria’s leadership in regulatory excellence.
Why Maturity Level 4 Matters
Reaching ML4 would make Nigeria eligible for WHO Listed Authority status (previously known as Stringent Regulatory Authority), allowing medicines and vaccines approved by NAFDAC to be accepted for trade and use worldwide without redundant re-approval. This would:
Boost global confidence in Nigerian medical products
Expand export opportunities for local manufacturers
Create jobs and strengthen the economy
Improve public health outcomes and universal health coverage
Adeyeye emphasised that the journey to ML4 involves strict, evidence-based audits.
“ML3 has about 260 sub-indicators and over 800 recommendations. ML4 is even more demanding. But we are moving ahead with determination.”
Collaboration as the Game-Changer
PCN Registrar, Ibrahim Ahmed, highlighted that the WHO re-benchmarking process tested not just each agency’s capacity, but also their ability to coordinate effectively.
“These agencies don’t just serve themselves—they serve Nigeria,” Ahmed explained, noting that the heads of NAFDAC and PCN now sit on each other’s governing councils to ensure unified decision-making.
According to both leaders, this partnership is key to sustaining progress, avoiding regulatory overlap, and building a pharmaceutical system that can compete globally.
With only 30 benchmarks left to close before achieving ML4, Nigeria is positioning itself not just as a regional leader, but as a credible player on the global stage in medicine regulation.
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