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Nigeria’s 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), marking a major leap in the nation’s regulatory advancement.
The announcement was made at the ICH Assembly held recently in Singapore.
With the development, Nigeria becomes the 24th out of only 25 national regulatory authorities (NRAs) worldwide recognised for their commitment to globally harmonised pharmaceutical standards.
NAFDAC Director General, Prof. Moji Adeyeye, described the achievement as “a historic breakthrough for Nigeria and the African continent.”“Full ICH membership means Nigerians will have better access to high-quality, safe, and effective medicines.
“It shows that our regulatory scientists can stand shoulder-to-shoulder with the best in the world.”NAFDAC began its journey toward full membership in late 2022 after securing Observer status. The Agency participated in the 2023 ICH meeting in Vancouver, Canada, where it delivered a formal presentation as part of the evaluation process.
Over the next two years, NAFDAC engaged in intensive capacity-building activities, including training on multiple ICH guidelines and active participation in Expert Working Groups. A major milestone was the international workshop held in Lagos in April 2025 on the ICH M13A guideline (Bioequivalence), which drew manufacturers and regulators from across Africa.
Adeyeye said 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.
Nigeria’s Ambassador to Singapore, H.E. Omayuli Francisca Kemi, who received the NAFDAC team during the ICH Assembly, lauded 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,” she said.
Full ICH membership empowers NAFDAC to contribute directly to the development of international pharmaceutical guidelines and apply them locally to strengthen decision-making. It is also expected to speed up access to innovative therapies, improve the quality of locally manufactured medicines, and enhance investor confidence in Nigeria’s pharmaceutical sector.
Adeyeye acknowledged members of NAFDAC’s Expert Working Groups for their “rigorous scientific input and countless hours of document review,” noting that their efforts demonstrated the nation’s readiness for global engagement.
She also credited 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,” she said.
NAFDAC expressed gratitude to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, local and international partners, and the Nigerian people for their continued support.
The Agency says it remains committed to full implementation of ICH guidelines, strengthening Nigeria’s regulatory ecosystem, and supporting pharmaceutical innovation and manufacturing.
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