In the dynamic world of global health, the ability to ensure the safety, quality, and efficacy of medical products is the cornerstone of public trust. For the National Agency for Food and Drug Administration and Control (NAFDAC), this commitment has reached a new milestone.
Nigeria is the first National Regulatory Authority (NRA) in Africa to successfully sustain the WHO ML3 status on the scope of medicine producing & vaccine importation.
What is WHO ML3?
The World Health Organization (WHO) Global Benchmarking Tool (GBT) is the gold standard for evaluating national regulatory authorities. Maturity Level 3 (ML3) signifies that a regulatory system is “stable, well-functioning, and integrated.” It confirms that NAFDAC has the institutional capacity to perform critical oversight functions—from clinical trial approvals and market authorization to pharmacovigilance and laboratory testing.
The Journey of Recertification
In March 2022, Nigeria made history by becoming one of the countries in Africa to achieve ML3. However, regulatory excellence is not a destination but a continuous process.
- Review: In late 2024, WHO experts conducted a rigorous Re-Benchmarking assessment of NAFDAC’s systems in Abuja and Lagos.
- The Focus: The team evaluated over 260 sub-indicators, reviewing the closure of Institutional Development Plans (IDPs) and auditing technical directorates regulating medical products.
- The Result: On June 30, 2025, the WHO officially recertified NAFDAC at Maturity Level 3, reaffirming our position as a regional leader in medicine and vaccine regulation.
Why This Matters to You
This achievement directly impacts the health and economy of every Nigerian:
- Promotes good regulatory practices in ensuring access, to safe, effective, quality and affordable essential medicines and vaccines
- Global Trust: Our ML3 status facilitates Regulatory Reliance, meaning other nations and international bodies can trust NAFDAC’s approvals, speeding up access to life-saving
- Boosting Local Manufacturing: By meeting international standards, we provide a stable environment for local pharmaceutical companies to produce vaccines and biologics, reducing our dependence on imports.
- Supply Security: NAFDAC’s maturity is key to regional harmonized approvals, ensuring that products manufactured in Nigeria can safely serve the entire ECOWAS sub-region.
Looking Ahead: The Road to ML4
While we celebrate this recertification, our eyes are on the future. NAFDAC is already aggressively pursuing Maturity Level 4 (ML4)—the highest global rank—and WHO-Listed Authority (WLA) status. This transition will involve deepening our digital transformation through the Integrated Regulatory Information Management System (IRIMS) and expanding oversight to emerging health technologies.
“This recertification is a testament to the tireless dedication of our staff. We remain customer-focused and agency-minded in our quest to safeguard the health of the nation.” — Prof. Mojisola Adeyeye, Director-General.
