Nigeria has achieved a major milestone in healthcare regulation as the National Agency for Food and Drug Administration and Control (NAFDAC) became the 24th out of only 25 national regulatory authorities worldwide recognized for their adherence to globally harmonized pharmaceutical standards.

NAFDAC Director General, Prof. Moji Adeyeye, described the achievement as “a historic breakthrough for Nigeria and the African continent.” She emphasized that full membership in the International Council for Harmonisation (ICH) 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,” she added.

NAFDAC began its path toward full membership in late 2022 after securing Observer status. The agency participated in the 2023 ICH meeting in Vancouver, Canada, presenting its case as part of the evaluation process. Over the next two years, NAFDAC engaged in extensive capacity-building activities, including training on multiple ICH guidelines and active involvement in Expert Working Groups. A key milestone was the international workshop on the ICH M13A guideline (Bioequivalence) held in Lagos in April 2025, which attracted regulators and manufacturers 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, praised the agency’s efforts during the ICH Assembly, calling it “a moment of pride for Nigeria” and highlighting NAFDAC’s leadership, resilience, and expertise on the global stage.

Full ICH membership empowers NAFDAC to contribute directly to developing international pharmaceutical guidelines and apply them locally, enhancing regulatory decision-making. The move is expected to accelerate access to innovative therapies, improve the quality of locally manufactured medicines, and boost investor confidence in Nigeria’s pharmaceutical sector.

Prof. Adeyeye also acknowledged NAFDAC’s Expert Working Groups for their “rigorous scientific input and countless hours of document review,” emphasizing that their dedication showcased Nigeria’s readiness for global engagement. She expressed gratitude to the Federal Government for extending her tenure, ensuring continuity during this 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 also thanked President Bola Ahmed Tinubu, the Minister of Health, local and international partners, and the Nigerian people for their continued support. The agency remains committed to full implementation of ICH guidelines, strengthening the national regulatory ecosystem, and supporting pharmaceutical innovation and manufacturing.