The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has confirmed Nigeria as a member.
Nigeria’s NAFDAC was admitted when the ICH Assembly met in Singapore from 18 to 19 November 2025, during its second in-person meeting this year.
At the same assembly, South Africa’s SAHPRA was also admitted as a member, while DIGEMAPS, the Dominican Republic, and the Philippine FDA were admitted as Observers.
The 35-year-old ICH now has 25 Members and 41 Observers.
ICH Membership criteria for national regulatory authorities include implementation of at least the three Tier 1 ICH Guidelines (Q1 Stability Testing Guidelines, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, and E6 Good Clinical Practice Guideline), participation in ICH biannual meetings, and a plan for implementing all ICH Guidelines.
ICH brings together regulatory authorities and the pharmaceutical industry to discuss the scientific and technical aspects of pharmaceutical development.
The association produces harmonised technical requirements to ensure the development and registration of safe, effective and high-quality medicines for human use.
