The National Agency for Food and Drug Administration and Control (NAFDAC) has secured full membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), marking a major milestone for Nigeria’s pharmaceutical regulatory system.
Gatekeepers News reports that previously an observer, NAFDAC was formally admitted as a full member during the ICH Assembly held in Singapore from November 18 to 19, 2025. The announcement was later published on the ICH website on November 26.
In a statement on Friday, NAFDAC’s director-general, Mojisola Adeyeye, described the development as historic, saying it positions Nigeria among “global leaders committed to the highest standards of quality, safety, and efficacy of medicines.”
The agency said the achievement will translate into “better access to high-quality medical products” for Nigerians, while boosting the competitiveness and credibility of local pharmaceutical manufacturers in regional and international markets.
NAFDAC’s path to full membership began in late 2022 when Adeyeye was advised to apply for observer status. The agency embarked on two years of intensive capacity building, meeting the final membership requirements in April 2025 after hosting an international workshop on ICH M13A (Bioequivalence) in Lagos, attended by regulatory heads from across the region.
“Our methodical and structured approach to meeting the criteria was central to this achievement,” the agency said.
NAFDAC noted that it received technical support from Northeastern University in Boston and the Bill & Melinda Gates Foundation through specialised training programmes.
Adeyeye commended the commitment of NAFDAC staff who contributed to the rigorous process, saying their efforts demonstrated that “Nigerian regulatory scientists can stand shoulder-to-shoulder with global experts.” She added that the federal government’s decision to extend her tenure ensured continuity and momentum under the renewed hope agenda.
With its new status, Nigeria becomes the 24th out of 25 national regulatory authorities worldwide participating in the harmonised, science-based global framework for pharmaceutical regulation.
NAFDAC said full ICH membership will strengthen Nigeria’s regulatory ecosystem, improve access to innovative medicines, attract foreign investment, and reinforce the country’s leadership in regional health initiatives such as the African Medicines Agency.
