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GuidanceMHRA

Clinical trials for medicines: International Council for Harmonisation (ICH) annotations

Information to help comply with ICH guidelines, if you are running clinical trials in the UK.

First published: Jan 12, 2026Last updated: Apr 27, 2026Changes: 3

Latest change: Added additional annotation related to Annex 1 2.3.2. The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft.

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