Nigeria has officially been confirmed as a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The admission was announced during the ICH Assembly’s second in-person meeting of 2025, held in Singapore from November 18 to 19. At the same session, South Africa’s SAHPRA was also admitted as a full member, while DIGEMAPS, the Dominican Republic, and the Philippine FDA were granted Observer status.
The ICH, now 35 years old, brings together 25 full members and 41 observers from around the world. Membership requires national regulatory authorities to implement at least the three Tier 1 ICH Guidelines—including Q1 Stability Testing, Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, and E6 Good Clinical Practice—attend biannual meetings, and maintain a roadmap for implementing all ICH guidelines. Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) met these criteria, signaling its readiness to align local pharmaceutical regulation with global standards.
By joining ICH, Nigeria gains a platform to collaborate with other regulatory authorities and the pharmaceutical industry on the scientific and technical aspects of drug development. The move is expected to enhance the safety, efficacy, and quality of medicines available to Nigerians while positioning the country as a key player in global pharmaceutical regulation. How soon will this membership translate into improved access to high-quality medicines in Nigeria? Visit www.jocomms.com for more news stories.
