The MHRA is setting out the next phase of clinical trial reforms for 2026, aimed at helping patients access new cutting-edge treatments more quickly and boosting the UK’s competitiveness for global clinical research.
The UK is ramping up efforts to become a global first choice for clinical trials, as new figures show a sharp rise in activity in 2025, and changes coming this year – including a fast-track route – that will help companies get studies up and running more quickly, so patients can benefit from new treatments sooner.
Data from the Medicines and Healthcare products Regulatory Agency (MHRA) show clinical trial applications received rose by 9% between January and November 2025 compared with the same period in 2024. Growth was strongest in early and innovative research, where speed and expert regulatory support can make or break decisions on where companies invest.
For example, trials involving healthy volunteers – often the first step in testing whether a new medicine is safe – increased by 16%, alongside rises in trials testing treatments in people for the first time (5%), and those being run in the UK for the first time (7%), a sign of growing international confidence in the UK as a place to launch new research.
Companies are also coming to regulators earlier for help. The number of MHRA scientific advice meetings provided on clinical trials rose by 75% over that period, as developers seek to design trials right first time and avoid costly delays later on.
These impressive gains have been made within the limitations of the current regulatory framework. A package of significant changes will be delivered with new clinical trial regulations due to take effect from April 2026. Under the new rules, around one in five studies are expected to move onto a fast-track notification route, which will allow lower-risk trials to start sooner, while maintaining high safety standards and freeing up experts to focus on complex and early-phase studies. The MHRA will also introduce a 14-day assessment route for phase 1 trials, adopting an innovative stepwise approach, restoring a rapid pathway for the earliest testing of new medicines in people – a key draw for global developers deciding where to base their research.
Alongside faster assessments, the new framework will support clearer, more agile routes to support innovation. This includes making better use of early safety data from overseas studies that meet UK standards, and new MHRA capability to assess computer model simulations, such as in-silico trials, to help predict how new medicines may behave before they are tested in patients. The aim is to reflect how modern medicines are developed today, without lowering safety standards.
More broadly, patient participation in clinical research is now higher than before the pandemic. Across England, more than 450,000 people took part in studies last year, underlining the role trials play in giving patients access to new treatments.
The figures build on consistently strong regulatory performance. Research published in the British Journal of Clinical Pharmacology in October 2025 shows that 99% of clinical trial applications received by the MHRA are reviewed on time, with most completed well ahead of target – giving trial sponsors greater certainty when planning studies in the UK.
MHRA Chief Executive Lawrence Tallon (pictured above) said: “Clinical trial sponsors are clear about what they need: speed, clarity and flexibility. We’ve made practical improvements that are helping trials move through the system more smoothly. The biggest shift is still to come. New rules will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace modern approaches, including adaptive trial designs and computer model simulations, while maintaining patient safety. Together, these reforms will help high-quality trials start sooner, giving patients earlier access to new medicines and making the UK a more competitive place to develop them.”