In a landmark achievement for Nigeria’s health sector, The National Agency for Food and Drug Administration and Control (NAFDAC), has been admitted as a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The announcement was made during the ICH Assembly held recently in Singapore.
With this development, Nigeria becomes the 24th — out of only 25 — national regulatory authorities (NRAs,) worldwide recognised for their adherence to globally harmonised pharmaceutical standards.
The elevation marks a major step forward in our nation’s quest to strengthen drug regulation, improve medicine quality, and deepen its integration into the global pharmaceutical ecosystem.
NAFDAC Director General, Prof. Moji Adeyeye, hailed the milestone 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,” she said. “It shows that our regulatory scientists can stand shoulder-to-shoulder with the best in the world.”
NAFDAC’s journey to full membership began in late 2022 after it attained Observer status. The Agency made its first formal presentation during the 2023 ICH meeting in Vancouver, Canada — a critical step in the evaluation process.
Over the following two years, NAFDAC underwent rigorous capacity-building, including training on several ICH guidelines and active involvement in Expert Working Groups. One of the most notable achievements during this period was the international workshop hosted in Lagos in April 2025 on the ICH M13A guideline (Bioequivalence), which brought together regulators and pharmaceutical manufacturers from across Africa.
Prof. Adeyeye attributed the Agency’s success to “a methodical and structured approach,” supported by Northeastern University in Boston and the Bill & Melinda Gates Foundation.
Nigeria’s Ambassador to Singapore, H.E. Omayuli Francisca Kemi, who received the NAFDAC delegation during the Assembly, commended the Agency’s dedication, applauding the milestone as a testament to Nigeria’s growing leadership in global health regulation.
The full ICH membership is expected to pave the way for stronger pharmaceutical oversight, improved public health outcomes, and greater confidence in medicines manufactured or imported into Nigeria.
May Nigeria succeed.
