ACDM News Item

Regulatory Considerations DMEG reviews recent MHRA regulatory updates

Date: April 22, 2026

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:

o AI/ML documentation for Data Management
o Clinical trial record archiving and retention
o Data protection and subject rights

View the paper here
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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