The Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) are introducing the largest package of reforms in over 20 years. This will 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 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.
Read the press release or visit the MHRA Clinical Trials Hub for more information and guidance.