Regulatory updates

What changed in clinical trial regulation

Each month we check the MHRA, HRA, legislation.gov.uk, EMA, ICH and the FDA, and explain the changes that matter to sponsors. Every change links to its official source.

April 2026
UK clinical trial regulation: what changed on 28 April 2026
Since 28 April 2026, UK clinical trials run under the 2004 Regulations as amended by SI 2025/538. Combined review and transparency are now legal duties, approvals lapse if no one is recruited within two years, safety reports go to the MHRA only, the trial master file must be kept for 25 years, and GCP means the ICH principles.

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