The ACDM Regulatory considerations DMEG Regulatory considerations reviewed several recent publications from the UK Medicines and Healthcare products Regulatory Agency (MHRA) including the release of new guidelines, updates to the Inspection Dossier templates and annotations to ICH E6 (R3) and ICH E8 (R1). These guidelines go into effect on April 28, 2026.
To assist data managers in complying with the new guidelines, the DMEG is releasing a summary of the highlights which impact data managers including:
The Regulatory Considerations DMEG will continue to review MHRA guidance as they are published, and an upcoming review will be on the Guidance on quality and risk proportionality (published 27 March 2026). In the interim, you can access that document at the MHRA Clinical Trial Hub: https://www.gov.uk/guidance/clinical-trials-for-medicines-guidance-on-quality-and-risk-proportionality
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New MHRA Guidance
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ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”
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