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 (www.gov.uk).
Government response to consultation on legislative proposals for clinical trials
Consultation on proposals for legislative changes for clinical trials - GOV.UK (www.gov.uk)