Nigeria Joins Elite Circle of Drug Regulators Through NAFDAC’s ICH Membership

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

The announcement was made by NAFDAC Director-General, Prof. Mojisola Adeyeye, following the ICH Assembly held in Singapore from November 18–19, 2025, and later published on the organisation’s website.

This transition elevates Nigeria from Observer to full member status in the exclusive global council, which brings together leading drug regulatory authorities and pharmaceutical industry stakeholders committed to scientific and technical excellence in medicine development.

Prof. Adeyeye described the achievement as “historic,” emphasizing that it positions Nigeria among global leaders committed to the highest standards of quality, safety, and efficacy in medicines.

“For our citizens, it means better access to high-quality medical products. For pharmaceutical manufacturers, it enhances competitiveness and confidence in Nigerian-made products both locally and internationally,” she said.

NAFDAC’s journey to full membership began in late 2022 with the application for Observer status. After rigorous training on ICH guidelines, active participation in Expert Working Groups, and capacity-building programmes supported by Northeastern University, Boston, and the Bill & Melinda Gates Foundation, the agency met all membership criteria by April 2025. The successful hosting of an international workshop on ICH M13A (Bioequivalence) in Lagos played a crucial role in this process.