Ich Information

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a non-profit organisation that brings together regulatory authorities and the pharmaceutical industry to discuss the scientific and technical aspects of pharmaceutical development. Through its working groups of regulatory and industry experts, ICH develops harmonised technical requirements to ensure the development and registration of safe, effective and high-quality medicines for humans. ICH also produces: • a standardised reference tool for medical terminology (MedDRA) that is now available in 27 languages; • a common format for submitting information to regulatory authorities (the Common Technical Document); • electronic standards for the transfer of regulatory information (ESTRI). Since it was created in 1990, ICH has finalized nearly 80 guidelines for technical requirements, which are increasingly applied by regulatory authorities around the world. As of October 2025, ICH has 23 members, 41 observers, and a network of nearly 700 experts globally. The ICH Association was registered as a non-profit legal entity under Swiss law in 2015.