The National Agency for Food and Drug Administration and Control (NAFDAC) today announced ambitious plans to achieve the World Health Organization's (WHO) Global Benchmarking Tool (GBT) Maturity Level 4, the highest regulatory rating.
This move builds on recent successes and leverages AI-driven reforms to enhance public health protection and regulatory efficiency.
Prof. Mojisola Adeyeye, NAFDAC's Director-General, unveiled these priorities during a media parley in Lagos titled “Modernisation and Foundation Laying of NAFDAC Regulatory Systems: Reflections on 2025.” She emphasized the agency's commitment to sustainability, innovation, and public health.
NAFDAC plans to deploy artificial intelligence in drug approval processes, safety monitoring, and efficacy assessments. This shift to “intelligent regulation” integrates AI with advanced analytics and digital systems. Additionally, the agency aims for full digitalisation of all regulatory processes to ensure fairness, consistency, and speed.
Moreover NAFDAC targets transition to ISO 9001:2026 certification. This builds on its existing Quality Management System, certified under ISO 9001:2015 from 2019. These steps will strengthen oversight of medicines, food, and other products.
The agency recalled its journey starting in January 2018. NAFDAC overcame challenges to attain WHO Maturity Level 3 for medicines regulation in 2022. It successfully re-benchmarked this status in 2025, becoming the first African regulatory authority to do so.
In addition, NAFDAC gained full membership in the International Council for Harmonisation (ICH) in November 2025. As the 24th member out of 194 global authorities, this milestone positions Nigeria among world leaders in pharmaceutical standards.
NAFDAC's reforms also focus on reducing import dependence. Policies like the 5+5 regulatory directive and Ceiling List have shifted the imported-to-local product ratio from 70:30 in 2019 to 60:40 in 2025. Contract manufacturing partnerships grew from 10 to 87 over the same period.
Furthermore, over 70 percent of products under these policies now come from local manufacturers. Decentralised food registration and risk based approaches enhance food safety nationwide.
Prof. Adeyeye stated, “Modernisation is not merely aspirational; it is already delivering tangible, measurable results that are safeguarding the health of Nigerians and fostering trade and economic growth.” She added that NAFDAC remains committed to science driven, transparent oversight aligned with global standards.
As a result, these initiatives will boost industry confidence, attract investments, and promote economic growth. NAFDAC calls on stakeholders to support this transformative agenda for better public health.