Nigeria’s National Agency for Food and Drug Administration and Control has secured full membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, placing the country among the world’s leading drug regulators.
The announcement was made at the ICH Assembly held in Singapore, where Nigeria was confirmed as the 24th out of only 25 national regulatory authorities recognised for commitment to global pharmaceutical standards.
NAFDAC’s Director General, Moji Adeyeye, described the development as a major step for Nigeria. She said, “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.”
Nigeria began its journey toward full membership in late 2022 after securing Observer status. The agency later took part in the 2023 ICH meeting in Vancouver, Canada, where it made a formal presentation as part of its assessment.
Over the last two years, NAFDAC carried out several capacity-building programmes, including training on various ICH guidelines and contributing to Expert Working Groups. A key milestone was the international workshop on the ICH M13A guideline held in Lagos in April 2025, which brought together regulators and manufacturers from different African countries.
Adeyeye said the progress followed “a methodical and structured approach,” supported by Northeastern University in Boston and the Bill and Melinda Gates Foundation.
Nigeria’s Ambassador to Singapore, Omayuli Francisca Kemi, praised the agency’s achievement. She said, “This is a moment of pride for Nigeria. NAFDAC has demonstrated leadership, resilience and expertise in earning a place on the global regulatory stage.”
With full membership, NAFDAC will now play a direct role in shaping international pharmaceutical guidelines and applying them in Nigeria. Officials say this will help speed up access to new treatments, improve the quality of locally made medicines and boost investor confidence in the sector.
Adeyeye thanked members of NAFDAC’s Expert Working Groups for their “rigorous scientific input and countless hours of document review,” noting that their work helped prove Nigeria’s readiness for global engagement.
She also credited the Federal Government for extending her tenure, saying it provided stability during an important phase. “We will continue to safeguard the health of the nation, now with the full strength of the ICH global community behind us,” she added.
NAFDAC also expressed appreciation to President Bola Tinubu, the Minister of Health and Social Welfare, partners at home and abroad, and Nigerians for their support. The agency said it remains focused on implementing ICH guidelines, improving the regulatory system and supporting growth in pharmaceutical manufacturing.
