Nigeria’s National Agency for Food and Drug Administration and Control has secured full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, marking a major leap in the nation’s regulatory advancement.
The official announcement was made at the recent ICH Assembly held in Singapore.
The development makes Nigeria the 24th out of only 25 national regulatory authorities worldwide to be recognised for their commitment to globally harmonised pharmaceutical standards.
NAFDAC Director General, Prof. Moji Adeyeye, described the achievement as “a historic breakthrough for Nigeria and the African continent.” She stated that “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.”
NAFDAC’s journey toward full membership began in late 2022 after the Agency first secured Observer status. This was followed by active participation in the 2023 ICH meeting in Vancouver, Canada, where the Agency delivered a formal presentation as part of the evaluation process.
Over the two years that followed, NAFDAC engaged in intensive capacity-building, including training on multiple ICH guidelines and active participation in Expert Working Groups.
A significant milestone was the international workshop on the ICH M13A guideline (Bioequivalence) held in Lagos in April 2025, which attracted manufacturers and regulators from across the African continent.
Professor Adeyeye attributed the Agency’s progress to “a methodical and structured approach,” noting that this was further boosted by support from Northeastern University in Boston and the Bill & Melinda Gates Foundation.
Nigeria’s Ambassador to Singapore, H.E. Omayuli Francisca Kemi, received the NAFDAC team during the ICH Assembly and lauded the Agency’s success, stating, “This is a moment of pride for Nigeria. NAFDAC has demonstrated leadership, resilience, and expertise in earning a place on the global regulatory stage.”
Full ICH membership empowers NAFDAC to contribute directly to the development of international pharmaceutical guidelines and apply them locally to strengthen regulatory decision-making. This new status is also expected to speed up access to innovative therapies, improve the quality of locally manufactured medicines, and enhance investor confidence in Nigeria’s pharmaceutical sector.
Adeyeye acknowledged members of NAFDAC’s Expert Working Groups for their “rigorous scientific input and countless hours of document review,” and highlighted that their efforts demonstrated the nation’s readiness for global engagement. She also credited the Federal Government for extending her tenure, saying it ensured continuity during the critical phase of the process.
Concluding her remarks, Professor Adeyeye affirmed, “We will continue to safeguard the health of the nation—now with the full strength of the ICH global community behind us.”
NAFDAC expressed its gratitude to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, local and international partners, and the Nigerian people for their continued support throughout the process. The Agency reaffirmed its commitment to the full implementation of ICH guidelines, strengthening Nigeria’s regulatory ecosystem, and supporting pharmaceutical innovation and manufacturing.
