UK regulator cuts late-stage clinical trial approval time to two weeks


The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%.

According to the plans, initial applications for the lowest-risk Phase III and IV trials will be processed by the MHRA within 14 days instead of the statutory 30 days.

This will only apply if the sponsor can demonstrate the trial meets the MHRA’s criteria, including by confirming there are no known safety issues with the medicine being investigated.

Dr June Raine, MHRA Chief Executive, said: “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.”

The scheme is based on that outlined in the MHRA’s clinical trials consultation which was endorsed by 74% of those who responded. It forms part of the regulator’s overhaul of the clinical trials regulation, which the governments hopes will make the UK one of the best countries in the world to conduct clinical research.

The MHRA predicts about 20% of UK initial clinical trial applications will be eligible for the scheme.

Steve Bates OBE, Chief Executive Officer of the BioIndustry Association (BIA), said: “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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