NAFDAC Joins World’s Elite Drug Regulators as Nigeria Secures Full ICH Membership

Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has achieved full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), placing the country among the world’s top drug regulatory authorities.

The milestone was announced during the recent ICH Assembly in Singapore.

With this development, Nigeria becomes the 24th out of just 25 national regulatory authorities (NRAs) globally recognised for their adherence to internationally harmonised pharmaceutical standards.

NAFDAC’s Director General, Prof. Moji Adeyeye, described the feat 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,” Adeyeye said.

NAFDAC began progressing toward full membership in late 2022 after first attaining Observer status. The agency later participated in the 2023 ICH meeting in Vancouver, Canada, where it delivered a formal presentation as part of the evaluation process.

Between 2023 and 2025, the Agency undertook rigorous capacity-building efforts, including training across multiple ICH guidelines and active involvement in Expert Working Groups. A key milestone was the international workshop held in Lagos in April 2025 on the ICH M13A Bioequivalence guideline, which brought together regulators and manufacturers from across Africa.

Adeyeye credited the Agency’s success to “a methodical and structured approach,” backed by support from Northeastern University in Boston and the Bill & Melinda Gates Foundation.

Nigeria’s Ambassador to Singapore, H.E. Omayuli Francisca Kemi, who hosted the NAFDAC delegation during the Assembly, praised the Agency’s achievement.

“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 gives NAFDAC direct influence in shaping international pharmaceutical guidelines and applying them domestically. The Agency says the status will enable faster access to innovative treatments, raise the quality of Nigeria’s locally manufactured medicines, and boost investor confidence in the nation’s pharmaceutical industry.

Adeyeye also commended members of NAFDAC’s Expert Working Groups for their “rigorous scientific input and countless hours of document review,” adding that their work proved Nigeria’s readiness for global engagement. She further acknowledged the Federal Government’s support, noting that the extension of her tenure helped ensure uninterrupted progress.

“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 appreciation to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, international partners, and Nigerians for their continued support.

The Agency reaffirmed its commitment to fully implementing ICH guidelines, strengthening the country’s regulatory environment, and promoting pharmaceutical innovation and manufacturing.

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