The UK is stepping up efforts to become a world leader in clinical trials, with new figures from the Medicines and Healthcare products Regulatory Agency (MHRA) revealing research activity will rise sharply in 2025.
The number of clinical trial applications from January to November 2025 increased by 9% compared to the same period in 2024, according to the MHRA.
The biggest growth has been in early-stage innovative clinical trials, an area where speed and regulatory guidance are key to influencing investment decisions.
Clinical trials involving healthy volunteers, often the first step in testing a drug’s safety, increased by 16%. Research evaluating treatments in patients for the first time increased by 5%, and clinical trials started in the UK for the first time increased by 7%, reflecting growing international confidence in the UK as a center for new research.
MHRA CEO Lawrence Tallon believes the latest reforms will further strengthen the UK as a clinical research hotspot, saying: “Clinical trial sponsors have made it clear what they need: speed, clarity and flexibility. We have made practical improvements that will help clinical trials move more smoothly through the system.”
“The biggest changes are yet to come. The new rules will make it easier to launch lower-risk research, better support early-stage research, and adopt modern approaches such as adaptive trial design and computer model simulation while maintaining patient safety.”
“Combined, these reforms will enable high-quality trials to start sooner, give patients access to new medicines sooner, and help the UK become more competitive in developing new medicines.”
Faster guidance and early support for developers
Companies are increasingly engaging with regulators early in the development process.
The MHRA’s scientific advice meetings for clinical trials will increase by 75% in 2025, helping developers design studies right from the start and avoid costly delays.
These early exchanges are seen as a key element in attracting global investment and keeping the UK competitive in cutting-edge research.
Accelerate access to new treatments
Building on these achievements, the MHRA will introduce major reforms to clinical trials regulation in 2026.
The new fast-track notification route will allow around 20% of low-risk studies to start more quickly, allowing experts to focus on complex early-stage trials while maintaining high safety standards.
Phase 1 studies, the first human trials of new drugs, introduce a 14-day evaluation pathway, restoring an expedited route that is particularly attractive to developers around the world.
The reform also incorporates modern approaches to trial design, including the use of early safety data from overseas studies and the evaluation of in silico simulations to model how drugs will behave before testing in patients.
These changes are intended to reflect current innovations in drug development without compromising patient safety.
Patient participation reaches new heights
Participation in clinical trials has also picked up since the pandemic. More than 450,000 people took part in research across the UK last year, highlighting the important role research plays in providing potentially life-saving treatments to patients early on.
Faster approvals and streamlined pathways mean more patients can benefit from innovative treatments sooner.
Strong regulatory track record supports growth
The UK’s strong regulatory track record remains a key attraction for global life sciences companies.
A study published in the British Journal of Clinical Pharmacology in October 2025 found that 99% of clinical trial applications received by the MHRA were reviewed on time, with most completed ahead of schedule.
This reliability provides greater certainty for sponsors and strengthens the UK’s reputation as a safe and efficient environment for conducting high quality clinical trials.
Driving the future of life sciences in the UK
The MHRA’s 2026 reforms are in line with the Government’s wider strategy to modernize clinical research through the UK 10 Year Health Plan.
By reducing the time from trial application to first participant to 150 days, the UK aims to give patients faster access to new treatments and strengthen its position as the world’s first choice for clinical trials.
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