Version 5, 7 February 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 5 was posted here. They will be considered in the next glossary version.
- ICH E2D(R1) Step 2 (draft). Post Approval Safety Data Management: Definition and Standards for Expedited Reporting. 5 February 2024.
- ICH Q3C(R9) Step 4 (final). Guideline for Residual Solvents. 24 January 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.