Version 7, 29 October 2024 —
This glossary combines the terms and definitions included in the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It was compiled by CIOMS from the publicly available guidelines found on the ICH website.
The guidelines themselves are owned by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). While every effort has been made to ensure the accuracy of this glossary, we cannot give any guarantee or take responsibility for errors or omissions. Please refer to the original ICH guidelines to verify the information provided.
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We are updating the glossary periodically. To our knowledge, the ICH guidelines listed below have become publicly available since Version 7 was posted here. They will be considered in the next glossary version.
- E6(R3) Annex 2 Subgroup Step 2 (draft). Guideline for Good Clinical Practice (GCP). Annex 2. 6 November 2024.
- M15 EWG Step 2 (draft). General Principles for Model-Informed Drug Development. 6 November 2024.
You will find the latest news from ICH here: https://ich.org/page/news
CIOMS welcomes all feedback. Please e-mail your recommendations to info@cioms.ch.