The U.K. is rolling out new regulations meant to reduce red tape for clinical studies and boost the nation’s role in international trials.
The law, an update of the Medicines for Human Use (Clinical Trials) regulations from 2004, entered a one-year implementation period April 11 and will go into full effect April 10, 2026.
The changes are designed to simplify regulations and reduce delays to ultimately support Prime Minister Keir Starmer’s goal of trimming the time it takes for trials to dose their first participant from 250 days post-application to 150 days.
The new rules also involve codifying a system called "combined review" into law. This system allows researchers to apply for ethics and regulatory approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in one fell swoop, with the aim of facilitating an approval decision within two weeks for low-risk trials.
“By embedding combined review in law, and strengthening the focus on transparency and proportionality, these changes reflect our commitment to making it easier to do high-quality research that people can trust,” Janet Messer, Ph.D., director of approvals service at the Health Research Authority (HRA), said in the April 11 announcement.
The HRA will be publishing further guidance for researchers about the new regulations in the coming months, Messer added. The HRA and the MHRA are separate agencies that fall under the purview of the U.K.’s Department of Health and Social Care.
The new regulations were proposed in December 2024 on the basis of independent reviews into the U.K. clinical trial industry and the National Health Service (NHS). In 2023, the U.K. appointed a former health minister, James O’Shaughnessy, to lead a review of the state of commercial clinical trials in the country after statistics showed patient recruitment had dropped precipitously.
The clinical trial reforms are part of a plan Starmer announced earlier this month to “turbocharge” medical research in the U.K. In addition to speeding up clinical trials, the government and the London-based nonprofit Wellcome Trust are investing 600 million pounds sterling (about $791 million) to create a new health data research service, meant to improve researcher access to NHS data.
“I am determined to make Britain the best place in the world to invest in medical research,” Starmer said in an April 7 statement about his plan. “That is not just good for patients and their families. It means growth that puts more money in working people’s pockets with more, better paid jobs.”