Clinical trials for medicines: Compliance with ICH E6 good clinical practice (GCP) in the United Kingdom

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the implementation of the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP) guidelines. Following the UK’s exit from the European Union, the regulatory framework has been updated through the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. Compliance with these updated principles becomes a legal requirement on April 28, 2026, replacing older standards previously based on EU legislation. The document addresses the need for a modernized, risk-proportionate approach to clinical trial oversight. While not an enforcement action against a single private company, it sets the mandate for all trial sponsors. Required actions include conducting documented impact assessments for trials active during the transition, implementing risk-based quality management systems, and ensuring personnel complete and document training on the new ICH materials. For trials not intended for marketing authorization, sponsors must provide clear justifications if they deviate from specific technical annexes. Future MHRA inspections will assess whether trial processes and computerized systems are fit for purpose and proportionate to the risks to participant safety and data reliability. Sponsors are encouraged to proactively document their compliance strategies and risk assessments to facilitate these upcoming regulatory reviews.