MHRA - Consultation on proposals for legislative changes for clinical trials

22nd March 2023

MHRA

Consultation on proposals for legislative changes for clinical trials

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.

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