Glossary of ICH Terms and Definitions published

An updated glossary of terms and definitions has been compiled and published by the Council for International Organizations of Medical Sciences (CIOMS) from across ICH Guidelines. This version 7 of the glossary is available after free registration on the CIOMS website, providing a useful resource of terms and definitions.

The Glossary includes all publicly available ICH guidelines and Q&A documents, including 'Step 2' (i.e., draft) and 'Step 4' (i.e., final) texts. The documents included are listed at the end of the glossary, together with their status at the time of issuing this Glossary version. The terms and definitions were taken from the Glossaries in the guidelines. Additional terms and definitions were identified by searching the text accordingly.

The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. CIOMS represents a substantial proportion of the biomedical scientific community through its member organizations, which include many of the biomedical disciplines, national academies of sciences and medical research councils. CIOMS mission is to advance public health through guidance on health research and policy including ethics, medical product development and safety. CIOMS is in official relations with WHO and is an associate partner of UNESCO.