Detailed GuideMHRA
Clinical trials for medicines: guidance on quality and risk proportionality
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
First published: Mar 27, 2026Last updated: Apr 27, 2026Changes: 3
Latest change: The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft.
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