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Clinical Insider

UK rejigs rules and promises 14-day approvals for low-risk clinical trials

Posted by on 17 October 2023
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New rules will see low-risk trials approved faster according to the UK’s MHRA, which says some studies could be green-lit in less than 14 days.

The regulator revised the requirements last week, explaining that applications for lowest-risk trials will be processed within 14 days instead of the statutory 30 days if the sponsor can demonstrate the trial meets certain criteria, including that the drug under investigation has no known safety issues.

Studies that meet the criteria will still need to be assessed by a research ethics committee prior to approval.

According to the Medicines and Healthcare products Regulatory Agency (MHRA) around 20% of UK initial clinical trial applications are expected to be eligible for the scheme.

MHRA chief executive, June Raine, said the idea was to speed start-up for certain trials with the ultimate aim being to increase access to innovative medicines.

“Clinical trials regulation should be flexible and risk-proportionate so that the regulatory requirements are geared to the risk that a trial presents.

“Our new notification scheme is exactly that. It will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety. This will help give UK patients quicker access to the potentially life-saving medicines being studied.”

The Westminster Government has been trying to make the UK a more attractive place in which to conduct drug research. As part of these efforts, in 2022, the MHRA began a clinical trials consultation to identify areas of regulation that could be tweaked to encourage sponsors.

The rule change is based on responses to this consultation. It is part of a wider overhaul of clinical trial regulations the MHRA outlined in March.

Steve Bates, CEO of the BioIndustry Association (BIA), welcomed the change, commenting “It is great to see this streamlined process for lower-risk late-stage trials rolled out. This is another measure by the agency to speed up clinical trial approvals and provide a timely and effective service to the life sciences sector.”


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