Clinical Trials

(asked on 21st May 2025) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps the Medicines and Healthcare products Regulatory Agency is taking to ensure that commercial clinical trials take place in the UK.


Answered by
Ashley Dalton Portrait
Ashley Dalton
Parliamentary Under-Secretary (Department of Health and Social Care)
This question was answered on 5th June 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced significant progress in modernising the United Kingdom’s clinical trials framework, marking the most substantial update in two decades. The announcement, made on International Clinical Trials Day, highlights a shift toward a more efficient, inclusive, and participant-focused regulatory system.

The new regulations, developed in partnership with the Health Research Authority and shaped by feedback from patients, researchers, clinicians, and industry, will come into full effect in April 2026 following a 12-month implementation period.

The reforms aim to streamline clinical trial approvals and place participants at the heart of trial design. Already, the MHRA has embedded improvements into its standard operations, with 100% of clinical trial applications processed within statutory timelines since September 2023. The average time for Combined Review determinations was just 40 days in March 2025, with all approvals completed within 60 days.

We are working with system partners to ensure that the whole process of Clinical Trials delivers as needed for all to encourage research in the UK.

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