HRA - Clinical trial regulations reform

7th May 2025

HRA - Clinical trial regulations reform

The Health Research Authority (HRA) has been working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to amend the Medicines for Human Use (Clinical Trials) Regulations 2004.

Our goal is to create a modern, streamlined regulatory environment that maintains high standards of participant safety while accelerating access to innovative treatments.

Feedback from a public consultation in 2022 helped shape proposals to improve how Clinical Trials of Medicinal Products (CTIMPs) are run in the UK. These changes aim to make the UK one of the best places in the world to conduct clinical research.

The updated regulations have now been approved. This page brings together everything you need to know during the implementation period and beyond.

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