NAFDAC secures full ICH membership, boosting Nigeria’s pharmaceutical standards, medicine safety, and global regulatory influence

LAGOS, Nigeria, December 5, 2025 – The National Agency for Food and Drug Administration and Control (NAFDAC) has officially secured full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), marking a historic milestone for Nigeria’s pharmaceutical sector.

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The announcement, made by NAFDAC Director-General, Prof. Mojisola Adeyeye, follows the ICH Assembly held in Singapore on November 18–19, 2025.

Nigeria’s transition from Observer to full member places the country among 25 global regulatory authorities dedicated to harmonised, science-based standards.

Prof. Adeyeye described the achievement as transformative, noting that it positions Nigeria as a leader in ensuring the quality, safety, and efficacy of medicines.

“For our citizens, it means better access to high-quality medical products. For our pharmaceutical manufacturers, it opens the door to improved competitiveness and confidence in Nigerian-made products,” she said.

The agency’s journey began in 2022 with an Observer application, followed by rigorous training, participation in Expert Working Groups, and adherence to stringent ICH guidelines.

Support from Northeastern University, Boston, and the Bill & Melinda Gates Foundation facilitated the capacity-building initiatives.

Key milestones included hosting an international workshop on ICH M13A (Bioequivalence) in Lagos in April 2025, gathering local manufacturers and regional regulatory heads.

This achievement also strengthens Nigeria’s role in regional regulatory integration and supports the African Medicines Agency initiative.

NAFDAC outlined multiple benefits of the full membership, including faster patient access to innovative therapies, enhanced training opportunities, and stronger global partnerships. Prof.

Adeyeye praised the agency’s staff for their dedication and meticulous scientific input, which she said demonstrated Nigeria’s ability to stand shoulder-to-shoulder with international experts.

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The agency expressed gratitude to President Bola Tinubu, the Minister of Health and Social Welfare, and local and international partners for their support, underscoring a commitment to uphold transparency, scientific integrity, and public health protection under the Renewed Hope Agenda.