Nigeria has been admitted as a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), marking a major milestone for the country’s pharmaceutical regulatory system.

The National Agency for Food and Drug Administration and Control (NAFDAC) was formally admitted during the ICH Assembly meeting held in Singapore from November 18 to 19, 2025, the second in-person assembly of the organisation this year.

At the same meeting, South Africa’s Health Products Regulatory Authority (SAHPRA) was also admitted as a member, while DIGEMAPS of the Dominican Republic and the Philippine Food and Drug Administration were granted observer status.

With the new admissions, the 35-year-old ICH now comprises 25 member regulatory authorities and 41 observers worldwide.

Membership of the ICH requires national regulatory authorities to meet strict criteria, including the implementation of at least three key Tier 1 ICH Guidelines — Q1 Stability Testing, Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, and E6 Good Clinical Practice — active participation in ICH biannual meetings, and a clear plan to implement all ICH guidelines.

The ICH serves as a global platform that brings together regulatory authorities and the pharmaceutical industry to harmonise scientific and technical standards. Its guidelines aim to ensure that medicines for human use are safe, effective, and of high quality.

NAFDAC’s admission is expected to strengthen Nigeria’s regulatory capacity, enhance confidence in locally regulated medicines, and improve the country’s integration into the global pharmaceutical system.