Proposals for legislative changes for clinical trials

Consultation opened on 17 January 2022. Closing date 14 March 2022.


The Medicines and Healthcare products Regulatory Agency (MHRA) led on a UK-wide consultation on a set of proposals to update, improve and strengthen the UK legislation that underpins the regulation of clinical trials. The consultation is now closed and the links to the relevant documentation including the consultation response document is provided below.

Consultation description

The MHRA sought views on proposed changes to the Human Medicine Regulations 2012 to improve and strengthen the UK clinical trials legislation (the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended), to help make the UK the best place to research and develop safe and innovative medicines. This provided an opportunity to improve regulations to support clinical trials in the best interests of patients, in line with the ambitions of the Life Sciences Vision to make the UK the leading global centre for innovative research design and delivery, across all types and phases of trials.

The legislative proposals outlined in this consultation, aim to streamline clinical trials approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement in clinical trials.

Link to Consultation Documents: 

The consultation can be accessed via: Annex B - Summary of consultation questions and how to respond - GOV.UK (

Government response to consultation on legislative proposals for clinical trials

Consultation on proposals for legislative changes for clinical trials - GOV.UK (

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