Have your say on future UK clinical trial legislation

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on far-reaching proposals to revise the clinical trial legislation in the UK.

idea of pharmaceutical or clinical trial regulation: close up of a doctors gloved hands holding up three wooden blocks with symbols for regelation or legislation, medicine and approval or certification

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on proposals to improve and strengthen the UK’s clinical trial legislation (the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended). The consultation is open until 14 March 2022.

The aim of the eight-week consultation is to gather public views on the proposals to improve the regulation of clinical trials in the best interests of patients. The MHRA stated: “In line with the ambitions of the Life Sciences Vision these proposals for UK legislation seeks to make the UK the leading global centre for innovative research design and delivery, across all types of trials. This consultation aims to develop a system which promotes patient and public involvement in clinical trials, improves the diversity of participants, streamlines clinical trial approvals, enables innovation and enhances clinical trials transparency.”

June Raine, Chief Executive of the MHRA commented: “This is a once-in-a-generation opportunity to review and update the UK legislation for clinical trials in order to make the UK the go-to place to develop new and innovative healthcare products. Through the proposals outlined in this consultation we aim to reframe the legislation that underpins our regulation of clinical trials to deliver a more streamlined, transparent and flexible regulatory regime whilst always protecting patients and trial participants.

“We are seeking the views of the wider public, clinical trial participants, researchers, developers, manufacturers, sponsors, investigators, healthcare professionals to help shape improvements for the future of clinical trials. We encourage you to get involved and help shape this important future legislation, for the ultimate benefit of patients.

This consultation will run 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.

Information on the consultation can be found here.