The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has officially confirmed Nigeria as a member, marking a significant milestone for the country’s pharmaceutical regulatory system.
Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) was admitted during the ICH Assembly held in Singapore from 18 to 19 November 2025, the second in-person meeting of the council this year.
At the same assembly, South Africa’s SAHPRA was also granted membership, while DIGEMAPS (Dominican Republic), the Philippine FDA, and others were admitted as Observers.
Established 35 years ago, ICH now comprises 25 Members and 41 Observers, further strengthening its global network of regulatory authorities and industry partners.
To qualify for membership, national regulatory authorities are required to implement at least three Tier 1 ICH Guidelines, Q1 Stability Testing, Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, and E6 Good Clinical Practice.
They must also participate in biannual ICH meetings and present a clear plan to implement all ICH guidelines.
ICH serves as a platform that brings together global regulators and the pharmaceutical industry to deliberate on scientific and technical aspects of drug development.
Its harmonised guidelines ensure that medicines developed and registered across member countries are safe, effective, and of high quality.
