National Agency for Food and Drug Administration and Control (NAFDAC) has been officially admitted as a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), after previously holding observer status.
Gatekeepers News reports that the decision was made during the ICH assembly meeting in Singapore from November 18 to 19, 2025, and announced on the council’s website on November 26.
Mojisola Adeyeye, NAFDAC director-general, described the milestone as historic, saying it positions Nigeria among global leaders committed to the highest standards of quality, safety, and efficacy of medicines.
She noted that Nigerians will benefit from improved access to high-quality medical products, while local manufacturers gain credibility and competitiveness in both regional and international markets.
NAFDAC began its path to full membership in late 2022, first applying for observer status, and spent 2023 strengthening its capacity through extensive training and reforms.
The agency met all final requirements in April 2025 after hosting an international workshop on ICH M13A (Bioequivalence) in Lagos, which gathered regulatory heads from across the region.
The statement highlighted support from Northeastern University in Boston and the Bill & Melinda Gates Foundation, which assisted in training programmes.
Adeyeye commended NAFDAC staff, saying their efforts proved that Nigerian regulatory scientists can stand shoulder-to-shoulder with global experts.
She also noted that the federal government’s decision to extend her tenure helped maintain continuity and consolidate progress.
With full membership, Nigeria becomes the 24th out of 25 national regulatory authorities worldwide to adopt harmonised, science-based standards for pharmaceutical regulation.
NAFDAC said the status will strengthen the country’s regulatory system, expand access to innovative medicines, attract foreign investment, and enhance Nigeria’s role in regional health initiatives, including the African Medicines Agency.
