Nigeria has achieved a landmark regulatory milestone as 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), placing the country among the world’s most advanced drug regulatory authorities.

The announcement was made at the ICH Assembly held in Singapore, where Nigeria was confirmed as the 24th country out of just 25 globally to attain full membership status.

The recognition marks a significant elevation in Nigeria’s global standing in pharmaceutical regulation.

NAFDAC’s Director General, Prof. Moji Adeyeye, described the achievement as “a historic breakthrough for Nigeria and the African continent,” noting that the development will transform access to quality medicines and strengthen public health outcomes.

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“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 quest for full ICH membership began in late 2022 after it secured Observer status. Over the years, the Agency intensified its efforts through rigorous capacity-building, participation in technical working groups, and adoption of international best-practice guidelines.

In 2023, NAFDAC made a strong impression at the ICH meeting in Vancouver, Canada, where it delivered a formal presentation as part of its evaluation.

This was followed by extensive training on multiple ICH guidelines and active involvement in global Expert Working Groups.

One of the key milestones was the high-level international workshop hosted in Lagos in April 2025 on the ICH M13A Bioequivalence guideline, which attracted regulatory bodies and pharmaceutical manufacturers from across Africa.

Prof. Adeyeye credited the progress to a “methodical and structured approach,” supported by Northeastern University in Boston, the Bill & Melinda Gates Foundation, and other technical partners.

Nigeria’s Ambassador to Singapore, H.E. Omayuli Francisca Kemi, who received the NAFDAC delegation during the Assembly, praised the Agency’s resilience and professionalism.

“This is a moment of pride for Nigeria,” she said. “NAFDAC has demonstrated leadership, competence, and consistency in earning its place on the global regulatory stage.”

With the new status, NAFDAC will now participate directly in shaping international pharmaceutical guidelines and apply globally harmonised standards to strengthen Nigeria’s drug regulatory system.

The impact is expected to include faster access to innovative therapies, improved quality of locally manufactured medicines, reduced proliferation of substandard drugs, and increased investor confidence in Nigeria’s pharmaceutical sector.

Prof. Adeyeye also applauded members of NAFDAC’s Expert Working Groups for their “rigorous scientific input and countless hours of review,” noting that their dedication demonstrated Nigeria’s preparedness for global integration.

She expressed gratitude to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, development partners, and the Nigerian public for their support.

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