The Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) have launched the largest package of reforms to clinical trials in over 20 years, aiming to help UK patients get access to new treatments faster.
New measures include faster assessment of first in human trials and the introduction of notifiable trials, a fast-track route to allow lower-risk trials to start sooner and modification to be approved quicker, whilst maintaining the highest safety standards.
The reforms – which come into effect on 28 April - will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace new approaches, including use of early safety data from overseas studies which meets UK standards and computer model simulations which can help to predict how new medicines may behave before they are tested in patients.
The regulators have already made headway towards delivering more streamlined and efficient approvals, which has contributed to exceeding the government’s ambitious target to reduce clinical trial set-up times to 150 days as part of its 10-year plan for the NHS. Latest figures show the contribution of the MHRA and HRA reducing set-up times from 169 days to just 122 days for studies going through combined safety and ethical review. The combined review process conducted by MHRA and HRA takes an average of 41 days, less than half of the time it took a few years ago.
This is good news for patients and researchers, enabling new trials to be set up more quickly and improving patient care. Innovations include the Route B substantial modification pathway which was successfully piloted from October 2025 to March 2026 and received strong support from the research community. It offers a faster, risk proportionate way to assess certain substantial modifications that do not introduce new safety concerns.
During the pilot, applications were processed in an average of just seven calendar days. Over half of registrations came from commercial sponsors, demonstrating strong industry engagement. From 28 April 2026, Route B will be legally mandated as part of the new regulatory framework. Under Route B, eligible modifications are automatically approved unless concerns are raised within calendar 14 days to inform the sponsor that a full assessment is being undertaken.
MHRA Chief Executive, Lawrence Tallon, said: “These reforms to clinical trial regulations are a boost both for patients and industry investment in R&D in this country. They will help to make the UK a more attractive, internationally competitive destination for both commercial and non-commercial clinical research. Most importantly, patients will benefit from earlier access to the latest, innovative medicines. We have listened carefully to the needs of patients, clinicians, researchers and industry to ensure we are delivering the most efficient, streamlined approvals process without compromising safety.”