The National Agency for Food and Drug Administration and Control (NAFDAC) is on an impressive trajectory, aiming for the World Health Organization’s Global Benchmarking Tool Maturity Level 4. This ambitious goal involves a comprehensive digital overhaul of its regulatory processes, the integration of artificial intelligence in drug approval and safety monitoring, and a robust commitment to strengthening local manufacturing capabilities. Director-General Prof. Mojisola Adeyeye shared these insights during a recent media event in Lagos, highlighting the agency’s significant strides in regulatory modernization since 2018.
A Vision for the Future
At the core of NAFDAC’s reform agenda is a dedication to sustainability, innovation, and public health protection. Adeyeye emphasized that the upcoming phase of reforms would not only build on previous successes but also cement Nigeria’s position as a leader in global and regional regulatory practices. This vision encapsulates the transition to ISO 9001:2026 certification, complete digitalization of regulatory workflows, and the adoption of AI technologies to enhance drug safety and efficacy evaluations.
The Foundation of Modernization
NAFDAC’s modernization journey commenced in January 2018, marked by a strategic initiative to align Nigeria’s regulatory frameworks with international standards and best practices. Adeyeye acknowledged the numerous challenges encountered along the way, but the agency’s commitment to establishing a solid foundation based on a Quality Management System and a robust legal framework has proven fruitful. This foundational work has been essential in fortifying the agency’s regulatory capacity.
Strategic Pillars of Change
The modernization efforts are anchored on five strategic pillars:
- Strong Leadership and Governance
- Institutionalization of Best Practices
- Safety and Quality of Regulated Products
- Continuous Monitoring Along the Supply Chain
- Efficient Financial and Performance Management
A significant milestone in this journey was the establishment of an agency-wide Quality Management System based on ISO 9001:2015, which led to NAFDAC’s certification in 2019. This certification has enabled the agency to develop and implement systems and procedures that ensure fairness and consistency in regulatory decision-making.
Progress in Medicines Regulation
The agency’s collaboration with the WHO Global Benchmarking Tool has been a transformative experience, marking a critical turning point in enhancing NAFDAC’s regulatory capacity. Adeyeye noted that Nigeria achieved WHO Maturity Level 3 status for medicines regulation in 2022 and successfully re-benchmarked in 2025, making it the first regulatory authority in Africa to reach this level.
A senior NAFDAC official likened this achievement to a report card, where Nigeria’s transition from Level 1 (failing) to Level 3 (excellent) has gained international recognition for its stable and integrated regulatory system.
Membership in Global Networks
In November 2025, Nigeria joined the International Council for Harmonisation (ICH) as its 24th member, a notable achievement given that only 25 out of 194 national regulatory authorities worldwide hold this membership. This affiliation underscores Nigeria’s growing stature in the global regulatory landscape.
Boosting Local Manufacturing
On the local manufacturing front, NAFDAC has implemented policies like the 5+5 regulatory directive and the Ceiling List to reduce dependency on imports and promote domestic production. Adeyeye reported that over 70% of products under these initiatives are now locally manufactured, reflecting increased confidence and investment in Nigeria’s pharmaceutical sector.
The ratio of imported to locally manufactured products has improved from 70:30 in 2019 to 60:40 in 2025, while the number of contract manufacturing partnerships has surged from 10 to 87 within the same timeframe.
Enhancements in Food Safety Regulation
NAFDAC has also made significant progress in food safety regulation. The introduction of decentralized food registration, the adoption of digital platforms, and risk-based regulatory approaches have collectively supported small and medium-scale food producers, enhancing regulatory efficiency.
Adeyeye affirmed that modernization is not just an aspirational goal; it is yielding tangible results that protect the health of Nigerians while fostering trade and economic growth.
Transition to Intelligent Regulation
Looking ahead, NAFDAC is transitioning from mere digitalization to “intelligent regulation.” This shift will leverage artificial intelligence, advanced analytics, and integrated regulatory systems to further enhance oversight capabilities. Adeyeye reiterated the agency’s commitment to safeguarding public health through science-driven, transparent, and globally aligned regulatory practices.
Conclusion
NAFDAC’s journey represents a bold initiative to redefine regulatory excellence in Nigeria. By embracing innovation and fostering local production, the agency not only aims for higher global standards but also reinforces the health and safety of its citizens. With its sights set firmly on the future, NAFDAC is poised to become a beacon of regulatory leadership in Africa and beyond.
- Key Takeaways:
- NAFDAC is targeting WHO Maturity Level 4 through digitalization and AI integration.
- The agency achieved WHO Maturity Level 3, becoming Africa’s first to reach this milestone.
- Local manufacturing initiatives have significantly reduced import dependence.
- NAFDAC’s membership in the ICH highlights its enhanced regulatory credibility.
- The transition to intelligent regulation promises improved oversight and public health protection.
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