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Cortex - Life Sciences Insights

| 1 minute read

Clinical Trial Regulations in the EU – how will the UK follow?

The European Medicines Agency has confirmed that the new Clinical Trials Regulation is now in effect as of 31 January 2022. Please see previous DLA articles on this blog for further detail.

In light of the EU taking measures to ensure for enhanced transparency and efficiencies in relation to clinical trials, it will be interesting to see how the UK responds. On 17th January 2022, the Medicines and Healthcare products Regulatory Agency (“MHRA”) launched an 8 week public consultation in relation to proposals for legislative changes for clinical trials in the UK. The purpose of the consultation is to gather views from the wider public, clinical trial participants, researchers, manufacturers, sponsors, investigators, healthcare professionals and similar, in relation to the proposed revisions to the clinical trials legislation in the UK. 

The government website set out an overview of the consultation, stating: “This eight-week consultation seeks your views on new proposals to improve regulation of clinical trials in the best interests of patients. In line with the ambitions of the Life Sciences Vision these proposals for UK legislation seeks to make the UK the leading global centre for innovative research design and delivery, across all types of trials. This consultation aims to develop a system which promotes patient and public involvement in clinical trials, improves the diversity of participants, streamlines clinical trial approvals, enables innovation and enhances clinical trials transparency.

The consultation is expected to end on 14 March, at which point the feedback will be carefully reviewed and will inform decisions to finalise the drafting of the UK secondary legislation in relation to 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.


clinical trials, europe, united kingdom, healthcare, health research