Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has earned full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), a milestone that marks a major step forward in the nation’s regulatory capacity.

The announcement was made at the ICH Assembly held recently in Singapore. With this development, Nigeria becomes the 24th of only 25 national regulatory authorities worldwide recognized for upholding globally harmonised pharmaceutical standards.

NAFDAC Director General, Prof. Moji Adeyeye, hailed the achievement as “a historic breakthrough for Nigeria and the African continent,” emphasizing that full ICH membership ensures Nigerians will have improved 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,” she said.

The journey toward full membership began in late 2022 after NAFDAC secured Observer status. The agency participated in the 2023 ICH meeting in Vancouver, Canada, delivering a formal presentation as part of its evaluation. Over the following two years, NAFDAC engaged in intensive capacity-building activities, including training on multiple ICH guidelines and active participation in Expert Working Groups. A key milestone was the international workshop held in Lagos in April 2025 on the ICH M13A guideline (Bioequivalence), which drew participants from across Africa.

Prof. Adeyeye credited the agency’s progress 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, commended the agency, describing the recognition as “a moment of pride for Nigeria” and highlighting NAFDAC’s leadership, resilience, and expertise on the global regulatory stage.

Full ICH membership empowers NAFDAC to directly contribute to international pharmaceutical guideline development and apply these standards locally. The move is expected to accelerate access to innovative therapies, enhance the quality of locally manufactured medicines, and boost investor confidence in Nigeria’s pharmaceutical sector.

Prof. Adeyeye acknowledged NAFDAC’s Expert Working Groups for their “rigorous scientific input and countless hours of document review,” noting that their efforts demonstrated Nigeria’s readiness for global engagement. She also credited the Federal Government for extending her tenure, ensuring continuity during this critical period.

“Moving forward, we will continue to safeguard the health of the nation, now with the full strength of the ICH global community behind us,” Adeyeye said. NAFDAC expressed gratitude to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, local and international partners, and Nigerians for their ongoing support. The agency reaffirmed its commitment to implementing ICH guidelines fully, strengthening Nigeria’s regulatory ecosystem, and promoting pharmaceutical innovation and manufacturing.