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). Guideline for Good Clinical Practice. Step 4 (final), 6 January 2025.
- E6(R3) Annex 2 Subgroup. Guideline for Good Clinical Practice (GCP). Annex 2. Step 2 (draft), 6 November 2024.
- M11 EWG. Clinical electronic Structured Harmonised Protocol (CeSHarP): M11 Template. Step 2 (draft), 13 March 2025. Updated, for reference only
- M11 EWG. Clinical electronic Structured Harmonised Protocol (CeSHarP): M11 Technical Specification. Step 2 (draft), 14 March 2025. Updated, for second round of public consultation
- M13B EWG. Bioequivalence for Immediate-Release Solid Oral Dosage Forms. Step 2 (draft), 13 March 2025.
- M15 EWG. General Principles for Model-Informed Drug Development. Step 2 (draft), 6 November 2024.
- Q1 EWG. Stability testing of drug substances and drug products. Step 2 (draft), 11 April 2025.
- Q8/9/10 Q&As (R5). Questions and Answers. Q8/Q9/Q10 – Implementation. Step 4 (final), 30 October 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 [email protected].