Nigeria joins global ICH elite as NAFDAC achieves full international regulatory Status

Nigeria joins global ICH elite as NAFDAC achieves full international regulatory Status

Nigeria has recorded a major milestone in global health regulation as the National Agency for Food and Drug Administration and Control (NAFDAC) has secured full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The achievement positions Nigeria among the world’s most advanced national regulatory authorities and marks a transformative step for the country’s pharmaceutical sector.

The announcement was made during the ICH Assembly held in Singapore, where Nigeria was confirmed as the 24th out of only 25 national regulatory authorities (NRAs) globally recognised for their commitment to harmonised international pharmaceutical standards.

NAFDAC Director General, Prof. Moji Adeyeye, described the development as a “historic breakthrough for Nigeria and the African continent,” noting that full membership would significantly boost the availability of high-quality, safe, and effective medicines for Nigerians.

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She said:
“Full ICH membership means Nigerians will have better access to high-quality medicines. It confirms that our regulatory scientists can stand shoulder-to-shoulder with the best in the world.”

Nigeria’s journey to full ICH status began in 2022 after the agency secured Observer status and later participated in the 2023 ICH meeting in Vancouver, Canada, where NAFDAC made a formal presentation as part of the evaluation process.

Over the last two years, NAFDAC underwent extensive capacity-building, including training on multiple ICH guidelines, membership in expert working groups, and the hosting of a major international workshop in Lagos in April 2025 on the ICH M13A Bioequivalence Guideline.

Adeyeye credited the agency’s success to a “methodical and structured approach,” supported by Northeastern University, Boston, and the Bill & Melinda Gates Foundation.

Nigeria’s Ambassador to Singapore, H.E. Omayuli Francisca Kemi, praised NAFDAC for demonstrating “leadership, resilience, and expertise” in earning a place on the global regulatory stage.

Full ICH membership grants NAFDAC authority to contribute directly to the formulation of international pharmaceutical standards, while enhancing Nigeria’s capacity to regulate medicines, accelerate access to innovative therapies, and improve confidence in local pharmaceutical manufacturing.

Adeyeye also acknowledged the Federal Government for extending her tenure, saying the continuity was crucial to achieving this milestone.

“We will continue to safeguard the health of the nation—now with the full strength of the ICH global community behind us,” she declared.

NAFDAC expressed appreciation to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, and its international partners for their support. The agency reaffirmed its commitment to full implementation of ICH standards, strengthening Nigeria’s regulatory system, and advancing pharmaceutical innovation and production.

Nigeria Joins Global ICH Elite as NAFDAC Achieves Full International Regulatory Status