Version 4, 20 July 2023 —
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 aiming to update the glossary approximately every three months. The following ICH guidelines have become available since Version 4 was posted here, and will be considered in the next glossary version:
- (none)
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.