The International Council for Harmonisation (ICH) confirmed two new Members and two new Observers at the 51st ICH Assembly in Singapore. With the joining of NAFDAC, Nigeria and SAHPRA, South Africa as Members and DIGEMAPS, Dominican Republic and Philippine FDA, Philippines as Observers, ICH now has a total of 25 Members and 41 Observers.
The ICH Assembly met in person on 18-19 November 2025 in Singapore in its second of two in-person meetings this year.
ICH Membership criteria for national regulatory authorities includes 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.
See the full list of ICH Members and Observers.
Photo L to R: Ms. Lenita Lindström (Assembly Chair - EC, Europe); Prof. Mojisola Adeyeye (NAFDAC, Nigeria); Dr. Gabriela Zenhäusen (Assembly Vice-Chair - Swissmedic, Switzerland)
Photo L to R: Ms. Lenita Lindström (Assembly Chair - EC, Europe); Ms. Silverani Padayachee (SAHPRA, South Africa); Dr. Gabriela Zenhäusen (Assembly Vice-Chair - Swissmedic, Switzerland)
Photo L to R: Ms. Lenita Lindström (Assembly Chair - EC, Europe); Mr. Darwin Yacer Marcelo Feliz (DIGEMAPS, Dominican Republic); Dr. Gabriela Zenhäusen (Assembly Vice-Chair - Swissmedic, Switzerland)
About ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss the scientific and technical aspects of pharmaceutical development. ICH produces harmonised technical requirements to ensure the development and registration of safe, effective and high-quality medicines for human use. Created in 1990, the ICH Association was registered as a non-profit legal entity under Swiss law in 2015. ich.org