Nigeria has achieved a major milestone in global health regulation as the National Agency for Food and Drug Administration and Control (NAFDAC) has been admitted as a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

This elevation from observer to full membership places Nigeria among only 25 national regulatory authorities applying globally harmonised, science-based pharmaceutical standards. The announcement was made at the ICH Assembly in Singapore that took place between November 18 and 19 and later published on the Council’s website.

For Nigeria, the development marks a strategic shift toward global best practices, stronger regulatory capacity, and improved access to quality medicines. The ICH is an exclusive global body that sets harmonised guidelines on how medicines are developed, tested, manufactured, registered, and monitored.

Full membership means NAFDAC now participates directly in shaping international pharmaceutical standards, an unprecedented position for Nigeria. NAFDAC’s journey began in 2022 when its Director General, Prof. Moji Adeyeye, was encouraged to seek observer status and after successfully presenting Nigeria’s readiness at the 2023 ICH meeting in Vancouver, the agency secured Observership status thus setting the stage for a roadmap to full membership.

Between 2023 and 2025, NAFDAC embarked on extensive capacity strengthening: training on ICH guidelines, participation in Expert Working Groups, stakeholder engagement including a major 2025 global workshop in Lagos on ICH M13A and technical support from Northeastern University, Boston, and the Bill & Melinda Gates Foundation. By April 2025, all requirements were met.

According to NAFDAC, full membership will significantly improve Nigeria’s medicine regulation by aligning decisions with globally accepted scientific standards. This will enhance the quality, safety, and efficacy of medicines in circulation.

Nigerians are expected to benefit from faster access to life-saving therapies due to increased confidence among global pharmaceutical innovators.

The statement added that NAFDAC now gains access to cutting-edge research, continuous training, and global scientific networks, strengthening its oversight of complex medical products.