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

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/8162f0da-fde3-4f47-a784-ed9e5f9d0b6c
Type: Guidance
Published: January 12, 2026
Updated: April 27, 2026

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

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## Content

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.

## Attachments

- [UK-specific annotations to ICH E6(R3)](/government/publications/international-council-for-harmonisation-ich-e6r3-annotations/uk-specific-annotations-to-ich-e6r3)
- [UK-specific annotations to ICH E8](/government/publications/international-council-for-harmonisation-ich-e6r3-annotations/uk-specific-annotations-to-ich-e8)