Clinical trial reforms are set to give UK patients faster access to new treatments, as the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) introduce the largest regulation reforms in over two decades.
The reforms, which came into force on 28 April, will include faster assessment of first in-human trials and the introduction of notifiable trials – a fast-track route that allows lower-risk trials to start sooner and for modifications to be approved quicker, without compromising patient safety.
Launching the reforms, Dr Zubir Ahmed, health innovation and safety minister, said: ‘This is a landmark moment for patients, researchers and our thriving life sciences sector that will make a real, tangible difference for thousands of people waiting for new treatments.
‘By introducing faster routes for lower-risk trials, embracing modern technology, and making the system simpler to navigate, we are reinforcing the UK’s position as one of the most attractive places in the world to invest in cutting-edge research.’
‘Earlier access to the latest, innovative medicines’
The reforms will make it easier to start studies that are considered lower risk, and strengthen support for early-stage research. They will also embrace new approaches, such as using early safety data from overseas studies that meet UK standards and computer model simulations to predict how new medicines may behave before they are tested in patients.
Innovations also 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. According to regulators, it offers a faster, risk proportionate way to assess certain substantial modifications that do not introduce new safety concerns.
Lawrence Tallon, MHRA chief executive, 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.’
The regulators have already made headway towards delivering more streamlined and efficient approvals, which has contributed to exceeding the Government’s target to reduce clinical trial set-up times from 169 days to 150 days as part of its 10-year plan for the NHS.
Dr Ahmed said: ‘The Government set itself an ambitious target to cut clinical trial set-up times to 150 days – and I’m proud to say we’ve gone further and faster than that. We have driven those times down to just 122 days from 169 this time last year for commercial trials, meaning patients across the UK are getting the latest, most innovative treatments sooner than ever before.’
Gerard Hanratty, partner and head of health and life sciences at the UK and Ireland law firm Browne Jacobson, said: ‘The key aim of UK regulatory change must be to make it easier for the NHS to adopt and use emerging technology.
‘Change is happening at speed, but we must be able to fast-track the integration of new systems. These reforms are a meaningful step in that direction, and they send a clear signal globally that the UK is serious about its ambitions as a leading destination for clinical research.’
A ‘patients first’ approach to regulation
Latest figures show that the combined review process conducted by MHRA and HRA now takes an average of 41 days, less than half of the time it took a few years ago.
According to the MHRA Results and Forecast report, also published on 28 April, the MHRA met or exceeded all statutory targets to increase access to medicines and medical devices for UK patients in 2025/26.
The report found that the regulator ended the year in a financial surplus; demonstrated a sustained improvement in external perception among industry, partners and system stakeholders; and saw an increase in staff morale.
Dr Ahmed said: ‘This past year has shown what a modern regulator looks like: patients first, pace where it matters, and standards that never slip… The direction of travel is clear. With the MHRA operating as a high-performance regulator, the UK is positioned as a global destination for life sciences that is open to innovation, serious about safety and credible on the world stage.’
A version of this article was originally published by our sister publication The Pharmacist.
