Reframing the UK legislation for clinical trials

The MHRA has launched an eight- week consultation on proposals for legislative changes for clinical trials.

Following the UK’s exit from the EU, The Medicines and Medical Devices Act 2021 allows the UK to update its current legislation in relation to clinical trials. The new proposals are based on feedback from stakeholders and an expert working group which included representatives from academia, industry and patient groups.

The Medicines & Healthcare products Regulatory Agency’s consultation aims to streamline clinical trials approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality and promote patient and public involvement in clinical trials.

Up until recently, reference to clinical trials has been dominated by those focused on Covid-19 vaccines and treatments. Now that the vaccines have moved the pandemic out of crisis stage, we expect to see an increase in clinical trials focused on other diseases that were temporarily paused.

The proposals are designed to improve and strengthen the UK clinical trials legislation to ensure that the “UK retains and grows its reputation as world leading base for life sciences”. The consultation provides an opportunity to respond to the needs of the sector, providing a more “streamlined and flexible regulatory regime” and supports the Government’s Life Sciences Vision policy paper published in July 2021.  

Responding to the consultation

The Agency is seeking views of the clinical trial participants, researchers, developers, manufacturers, sponsors, investigators, healthcare professionals and the wider public to help shape improvements to the legislation for clinical trials. The consultation will close at 11pm on Monday, 14 March 2022.

You can respond to the consultation here.

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