Consultation on proposals for legislative changes for clinical trials

The Medicines and Healthcare products Regulatory Agency (MHRA) are consulting on a set of proposals 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 is an opportunity to improve the regulation 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.

Through the legislative proposals outlined in this consultation, they 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.

They would value your views to help shape the future legislation for clinical trials and invite you to respond to their questions using the link here.

This consultation is open from 17 January until 14 March 2022.

All responses to this consultation will be carefully reviewed and will feed into the decisions that are made to finalise the proposals and consideration of the drafting of the secondary legislation.