Nigeria records a major regulatory breakthrough as NAFDAC transitions from observer status to full membership of the International Council for Harmonisation (ICH), positioning the country among global leaders in pharmaceutical regulation.

Nigeria’s pharmaceutical regulatory environment has reached a historic turning point following the attainment of full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) by the National Agency for Food and Drug Administration and Control (NAFDAC). The milestone signals Nigeria’s formal entry into the global decision-making space for pharmaceutical regulatory standards.

The elevation from observer to full member was officially announced at the ICH Assembly held on 18–19 November 2025 in Singapore and later published on the ICH website on 26 November 2025. With this development, Nigeria joins a select group of only 25 national regulatory authorities worldwide entrusted with implementing and shaping ICH guidelines.

From Observer Status to Global Recognition

NAFDAC’s journey toward full ICH membership began in 2022 when the Agency was admitted as an Observer. This phase allowed Nigeria to engage closely with international regulatory processes while building the technical capacity required for full integration. Over the years, NAFDAC demonstrated sustained commitment through active participation in ICH meetings, expert working groups, and extensive training on core ICH guidelines.

By April 2025, the Agency had successfully met all membership requirements, supported by strategic collaborations with Northeastern University, Boston, and the Bill & Melinda Gates Foundation. These partnerships strengthened regulatory science expertise and institutional preparedness, paving the way for Nigeria’s elevation to full membership.

Full ICH membership positions Nigeria not just as a regulator of medicines, but as a contributor to the global framework that defines how pharmaceutical products are evaluated, approved, and monitored worldwide.

Implications for Nigeria’s Health System and Industry

Full membership of ICH enables NAFDAC to contribute directly to the development and implementation of globally harmonised, science-based regulatory standards. This is expected to significantly enhance Nigeria’s access to high-quality medicines, improve regulatory efficiency, and reduce delays in medicine approvals.

For the local pharmaceutical industry, the implications are equally profound. Alignment with ICH standards strengthens local manufacturing capacity, improves export readiness, and boosts international confidence in Nigerian-made medicines. Ultimately, patients stand to benefit from safer, more effective, and higher-quality medical products.

Leadership, Policy Alignment, and the Road Ahead

The achievement reflects the strong leadership of NAFDAC’s Director-General, Prof. Mojisola Adeyeye, and the dedication of the Agency’s technical experts who have actively contributed to ICH Expert Working Groups. It also aligns with the Federal Government’s Renewed Hope Agenda, which prioritizes health system strengthening and improved access to quality healthcare products.

As NAFDAC commits to full implementation of ICH guidelines, the focus now shifts to translating global standards into tangible public health gains. This development not only strengthens Nigeria’s regulatory credibility but also reinforces Africa’s growing voice in global health governance.

About the Author

RxRelated Editorial Team is a multidisciplinary group of pharmacy professionals, researchers, and health policy analysts dedicated to providing in-depth reporting and analysis on pharmaceutical regulation, practice, and innovation in Nigeria and across Africa.