UK regulator looks to halve time to approve low-risk clinical trials

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has established new guidelines designed to halve the time the regulator takes to approve lower-risk clinical trials.

The program, which was announced Oct. 12, represents a major element of the MHRA’s overhaul of trial regulations as part of efforts to boost the U.K. as a preferred location to hold clinical studies, the medicines watchdog said in a press release.

Applications for lowest-risk phase 3 and phase 4 trials will be processed by the organization within 14 days—versus the previous 30-day wait—if the sponsor is able to demonstrate the trial meets MHRA criteria, including confirmation that there are no known safety issues.

The agency estimates that about 20% of initial clinical trial applications it receives will be eligible for this approach. Applications to amend a clinical trial will not be eligible, it pointed out.

“Clinical trials regulation should be flexible and risk-proportionate so that the regulatory requirements are geared to the risk that a trial presents,” MHRA CEO June Raine said in the release. “It will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety.”

The MHRA announced in March that it planned to roll out new measures to make running clinical trials easier. It was the first time in 20 years that the regulatory body has undergone such an overhaul and followed the watchdog taking over the regulation of clinical trials in the country from the European Medicines Agency following the U.K.'s departure from the EU.

In May, the U.K. government pledged that a chunk of the 650 million pound sterling ($803 million) funding package it has earmarked to boost the country’s life sciences industry will go toward reversing a slowdown in clinical trial uptake.