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Public Consultation on new Clinical Trials Legislation

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The MHRA has launched an  8-week public consultation on proposals for legislative changes for clinical trials.

Following the UK’s exit from the European Union, the Medicines and Medical Devices Act allows us the opportunity to update our current legislation in relation to clinical trials (Statutory Instrument 2004/1031, and its numerous amendments). The new proposals are based on feedback from our stakeholders and an Expert Working Group, which included representatives from academia, industry, and patient groups.

We would like to update current legislation to allow us to streamline the regulation of clinical trials approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement in clinical trials.

We recognise that this cannot be achieved by legislation alone and will be developing guidance to ensure appropriate interpretation of the legislation. The legalisation is one aspect of the UK vision for clinical research delivery:  Saving and improving lives: the future of UK clinical research delivery, a key theme of which is to deliver streamlined, efficient and innovative research – so the UK is seen as the best place in the world to conduct fast, efficient and cutting-edge clinical research.

We are seeking the views of 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 – we look forward to receiving your comments.

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  1. Comment by Karl Fry posted on

    Improvements for transparency and efficiency are welcomed but significant divergence from EU GMP will inevitably make GB less attractive as a 'tag on' country when overseas sponsors are considering which European countries to include for their clinical trials

    • Replies to Karl Fry>

      Comment by Martin O'Kane posted on

      Thank you for your comment. A key objective of the proposals is to ensure any new legislation builds international interoperability so that the UK remains a preferred site to conduct multi-national trials.

  2. Comment by Richard Smalley posted on

    I think that is a good goal to work towards Martin. Whilst not easy to achieve, “divergence from EU GMPs” doesn’t necessarily have to be significant from a compliance perspective (if U.K. is still compliant with PICS), but could remove barriers and make the process more efficient.

  3. Comment by Shah Ashraf posted on

    Thank You for the Information. It becomes a very important guidance to us when performing a Clinical Study Quality Review Internationally.
    Looking forward to see such more direct guidance from MHRA in future.