MHRA revamps UK clinical trial regulation with the promise of faster timelines

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来源: Pharmaceutical Technology

Credit: Shutterstock/ Ralf Liebhold

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things. These changes come following a public consultation with the Healthcare Research Authority, to which a government response was published on March 21.

The MHRA plans to shorten the timeline for the completion of an application review to a maximum of 30 days, and a maximum of 10 calendar days to make a final decision upon receipt of further information. Furthermore, the UK is now implementing a legislative requirement to publicly register clinical trials and share summary results with any research participants. The new framework will introduce a legal mandate to register a trial in the World Health Organisation (WHO) public register. Researchers will also have to publish a summary of results within 12 months of the end of the trial. The press release stated that sharing trial findings with participants in a, yet to be defined, “timely manner and suitable format” will also be required by law.

The agency reports that, in the pilot phase, these revisions halved the approval times for studies and cut the time from application to recruiting the first patient by 40 days. The new regulation has been designed to embed these changes. .

The new rules are particularly relevant as new trends and innovation are taking precedence in clinical trial design. MHRA hopes to keep more modern trial designs in mind, such as decentralised clinical trials, with these developments.

In a press release, Marc Bailey, MHRA’s Chief Science and Innovation Officer, said “Our world-first Covid-19 approvals showed how important it is to ensure that regulation is flexible and agile. This overhaul of the clinical trials legislation will do just this – it will move us away from a one-size-fits-all approach to the regulation of clinical trials and help to streamline approvals by removing granular and duplicative regulatory requirements”.

The news arrives after a 2022 The Association of the British Pharmaceutical Industry (ABPI) report said the UK’s collapsing clinical research industry was collapsing. Between 2017 and 2021, the number of industry-led Phase III trials initiated fell by 48%, as per the report. In an announcement after the MHRA’s release, the ABPI’s Chief Executive, Ricard Torbett responded positively to the UK regulator’s changes. He said, “It’s great to see the MHRA taking forward these important changes to UK clinical trials regulation centred on patient safety and the benefits of participating in research”.

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