ICH E6(R3) annotations — UK guidance published

13th January 2026

ICH E6(R3) annotations — UK guidance published

Summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has released a set of annotations for ICH E6(R3) — the latest revision of the international Good Clinical Practice (GCP) guideline — to support implementation by UK clinical trial sponsors and investigators. These annotations explain how specific sections of E6(R3) should be interpreted in the UK regulatory context, clarifying expectations around risk-proportionate trial design, quality management systems, proportionate documentation, safety reporting and data integrity. The document is intended to reduce ambiguity by aligning ICH principles with UK approaches to clinical trial oversight and inspection readiness, while supporting improved trial efficiency and participant protection. It includes references to UK legislation where relevant and examples of practical application.

This guidance is particularly useful as the UK transitions to updated clinical trial regulations, encouraging sponsors to adopt modern quality-by-design practices and to engage early with MHRA on complex trial issues.

Link: International Council for Harmonisation — ICH E6(R3) annotations

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