Guidance

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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 12 January 2026
• Last updated: 28 April 2026
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  1. 28 April 2026

     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.

  2. 9 March 2026

     On the document 'UK-specific annotations to ICH E6(R3)': added reference to ICH E8. Added annotation to Annex 1 2.6.4; updated annotation to Annex 1 2.13 and Annex 3.17.2 (c)(iii) to include reference to HRA guidance on research transparency; updated annotation to Annex 3.17.2 (c)(ii) to clarify that action should be taken in accordance with the protocol. Added document 'UK-specific annotations to ICH E8'.

  3. 12 January 2026

     First published.

Documents

UK-specific annotations to ICH E6(R3)

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UK-specific annotations to ICH E8

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Details

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.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)  has produced a series of international guidelines concerning the design, conduct, safety and reporting of clinical trials (the Efficacy guidelines).  

In places, these guidelines include references to “applicable regulatory requirements” or similar in the relevant ICH region. The documents linked on this page are intended to support those involved in running clinical trials in the UK to comply with the ICH Efficacy guidelines by specifying what the applicable regulatory requirements or relevant guidance documents are for the UK.