Mojisola Adeyeye, NAFDAC DG
The National Agency for Food and Drug Administration and Control (NAFDAC) has secured full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The agency, which previously held observer status, was formally admitted as a full member during the ICH assembly meeting held in Singapore from November 18 to 19, 2025. The official announcement was later published on the ICH website on November 26.
A statement on Friday by Mojisola Adeyeye, NAFDAC director-general, said the achievement was historic, and that the development places Nigeria among “global leaders committed to the highest standards of quality, safety, and efficacy of medicines”.
The agency added that for Nigerians, the milestone means “better access to high-quality medical products”, while local manufacturers will gain improved competitiveness and credibility in regional and international markets.
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NAFDAC’s journey to full membership began in late 2022, when Adeyeye was advised to apply for observer status and the agency embarked on two years of intensive capacity building in 2023.
The agency said it met the final membership requirements in April 2025 after hosting an international workshop on ICH M13A (Bioequivalence) in Lagos, which also brought together regional regulatory heads.
“Our methodical and structured approach to meeting the criteria was central to this achievement,” the statement reads.
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NAFDAC added that it received support from Northeastern University in Boston and the Bill & Melinda Gates Foundation for training programmes.
Adeyeye praised the dedication of NAFDAC staff who contributed to the rigorous process, saying their work proved that “Nigerian regulatory scientists can stand shoulder-to-shoulder with global experts”.
She added that the federal government’s decision to extend her tenure supported continuity and consolidation of progress under the renewed hope agenda.
With full ICH membership, Nigeria becomes the 24th out of 25 national regulatory authorities worldwide committed to harmonised, science-based standards for pharmaceutical regulation.
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NAFDAC said the new status will strengthen Nigeria’s regulatory ecosystem, enhance access to innovative medicines, attract foreign investment, and reinforce the country’s role in regional health initiatives, including the African Medicines Agency.
