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More information28th April 2026
Summary:
The MHRA has confirmed that updated guidance on compliance with ICH E6 Good Clinical Practice (GCP) is now in force in the UK, marking an important step in modernising clinical trial standards. The guidance reflects current expectations for trial design, conduct, oversight, and risk management, with a stronger emphasis on proportionality, quality by design, and participant safety. Its implementation signals a shift towards more flexible, risk-based approaches while maintaining robust regulatory oversight. Organisations involved in clinical research are now expected to align their processes with this updated framework, ensuring compliance with the latest international standards.