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)
NAFDAC described this as a major leap in the nation’s regulatory advancement.
NAFDAC was formally admitted as a full member during the ICH Assembly meeting held in Singapore from November 18 to 19, 2025. It was announced by the ICH on November 26, 2025 via its website.
A statement on Friday by the NAFDAC Director General, Prof Mojisola Adeyeye, noted that with the development, Nigeria has become the 24th out of only 25 national regulatory authorities (NRAs) worldwide recognized for their commitment to globally harmonised pharmaceutical standards.
Adeyeye described the achievement as “a historic breakthrough for Nigeria and the African continent”, adding that the development places Nigeria among “global leaders committed to the highest standards of quality, safety, and efficacy of medicines”.
NAFDAC also noted 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.
The agency’s journey to full membership began in the last quarter of 2022, when Adeyeye was advised to apply for observer status. It later embarked on two years of intensive capacity building in 2023.
NAFDAC 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.
“The Agency fulfilled the necessary requirements in April 2025 following the successful international workshop on ICH M13A (Bioequivalence), during which NAFDAC convened stakeholders in Lagos including manufacturers and engaged virtually with Heads of regional regulatory agencies,” the statement read.
According to Adeyeye, the Agency’s progress was the result of “a methodical and structured approach,” boosted by support from Northeastern University in Boston and the Bill & Melinda Gates Foundation.
She further commended the dedication of NAFDAC staff who contributed to the rigorous process, stating that their work proved that Nigerian regulatory scientists can stand shoulder-to-shoulder with global experts.
She also lauded the Federal Government for extending her tenure, saying it ensured continuity during a critical phase.
“We will continue to safeguard the health of the nation, now with the full strength of the ICH global community behind us,” Adeyeye said.
Also, Nigeria’s Ambassador to Singapore, H.E. Francisca Kemi, who received the NAFDAC team during the ICH Assembly, commended the Agency’s effort.
“This is a moment of pride for Nigeria. NAFDAC has demonstrated leadership, resilience, and expertise in earning a place on the global regulatory stage,” Kemi said.
She also noted that full ICH membership will empower NAFDAC to contribute directly to the development of international pharmaceutical guidelines and apply them locally to strengthen decision-making.
She added that it is also expected to speed up access to innovative therapies, improve the quality of locally manufactured medicines, enhance investor confidence in Nigeria’s pharmaceutical sector, and improve stronger global partnerships.
NAFDAC, while extending gratitude to President Bola Tinubu, Minister of Health and Social Welfare, the local and international partners, and Nigerians for their continued support, reaffirmed its commitment to full implementation of ICH guidelines, strengthening Nigeria’s regulatory ecosystem, and supporting pharmaceutical innovation and manufacturing.
