Consultation on proposals for legislative changes for clinical trials
Read the full outcome
Detail of outcome
The MHRA and the Department of Health in Northern Ireland, working closely with the HRA, consulted on a set of proposals to update, improve and strengthen the UK legislation that underpins the regulation of clinical trials. Having analysed over 2000 responses received, we will now take forward legislation to reform of the UK clinical trials regulatory framework that will:
- Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone
- Create a proportionate and flexible regulatory environment
- Cement the UK as a destination for international trials
- Provide a framework that is streamlined, agile and responsive to innovation
This package of changes will deliver on our vision for a more proportionate, streamlined, flexible and effective clinical research environment, putting patients at the heart and the UK at the forefront of innovative regulation for clinical trials.
Original consultation
Consultation description
We 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 us make the UK the best place to research and develop safe and innovative medicines. We have the opportunity to improve our 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 we 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.
We would value your views to help shape the future legislation for clinical trials. We invite you to respond to our 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.
Documents
Updates to this page
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Government response to consultation published.
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First published.