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New proposals for the future of UK clinical trial legislation

Government seeks views on “far-reaching” proposals to revise clinical trial legislation in the UK that they dub “better regulation…for better trials…for better health.”

The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a public consultation on a set of far-reaching proposals to improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines.

“This is a once-in-a-generation opportunity to review and update the UK legislation for clinical trials”

Dame June Raine, Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA)

Clinical trials are vitally important for achieving advances in medical treatment. Clinical trials may be conducted for a range of purposes, for example to assess whether a new treatment or combination of treatments is safe and effective, or to explore new ways to use existing medicines – as has been seen with the rapid introduction of new vaccines and therapeutics for COVID-19.

This eight-week consultation seeks the public’s views on new proposals to improve regulation of clinical trials in the best interests of patients. In line with the ambitions of the Life Sciences Vision, these proposals for UK legislation seek to make the UK the leading global centre for innovative research design and delivery, across all types of trials.

The MHRA says that the consultation is aimed at developing 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.

In a statement, Chief Executive of the MHRA, Dame June Raine said:

“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.”

Have your say:

The consultation will run from 17 January until 14 March 2022. All responses will be reviewed to inform decisions to finalise the drafting of the secondary legislation.

The consultation documents can be found here.

Join the Debate:

To ask a panel of leaders in the sector questions about this consultation directly, apply to join a topical panel question time event at one of the world’s most exciting centres for biotechnology, life sciences and research. Pre-submit your questions to ask the panel live in Cambridge on 20th January.

Joined by the Science Minister, George Freeman this is an excellent opportunity to discuss ways in which the UK can become a global leader in clinical trials.

Book tickets here.

Cambridge Life Sciences 2

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