“Nigeria’s NAFDAC Joins Global Pharmaceutical Elite, Secures Prestigious ICH Membership”
By Passman Akpos
In a landmark achievement for Nigeria’s pharmaceutical sector, the National Agency for Food and Drug Administration and Control (NAFDAC) has officially been confirmed as a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The announcement came during the ICH Assembly’s second in-person meeting of the year, held in Singapore from November 18 to 19, 2025. Alongside Nigeria, South Africa’s SAHPRA was also admitted as a member, while DIGEMAPS, the Dominican Republic, and the Philippine FDA joined as Observers.
With this development, the 35-year-old ICH now boasts 25 Members and 41 Observers worldwide. Membership is no small feat: national regulatory authorities must implement at least the three Tier 1 ICH Guidelines — Q1 Stability Testing, Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, and E6 Good Clinical Practice — participate in ICH biannual meetings, and have a clear plan for rolling out all ICH Guidelines.
NAFDAC’s inclusion signals Nigeria’s rising influence on the global pharmaceutical stage. ICH, which unites regulatory authorities and the pharmaceutical industry, works to harmonise technical requirements, ensuring medicines are safe, effective, and of the highest quality for human use.
This historic recognition positions Nigeria among the world’s pharmaceutical elite, opening doors for enhanced collaboration, capacity building, and global trust in locally produced medicines.
