The UK is stepping up its bid to become a global leader in clinical trials, with new figures from the Medicines and Healthcare products Regulatory Agency (MHRA) revealing a sharp increase in research activity during 2025.
According to the MHRA, applications for clinical trials rose by 9% between January and November 2025 compared with the same period in 2024.
The strongest growth was seen in early-phase and innovative trials, critical areas where speed and regulatory guidance influence investment decisions.
Trials involving healthy volunteers, often the first step in testing a medicine’s safety, increased by 16%. Studies assessing treatments in patients for the first time rose by 5%, while trials launched in the UK for the first time climbed 7%, reflecting growing international confidence in the country as a hub for new research.
MHRA Chief Executive Lawrence Tallon believes the latest reforms will further amplify the UK as a hotspot for clinical research: “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.”
Faster guidance and early support for developers
Companies are increasingly engaging regulators earlier in the development process.
MHRA scientific advice meetings for clinical trials jumped by 75% in 2025, enabling developers to design studies correctly from the outset and avoid costly delays.
These early interactions are seen as a key factor in attracting global investment and ensuring the UK remains competitive for cutting-edge research.
Speeding up access to new treatments
Building on these gains, the MHRA is introducing major reforms to clinical trial regulations in 2026.
A new fast-track notification route will allow around 20% of lower-risk studies to start more quickly, maintaining high safety standards while freeing experts to focus on complex early-phase trials.
For phase 1 studies – the first in-human testing of new medicines – a 14-day assessment pathway will be introduced, restoring a rapid route that is particularly attractive to global developers.
The reforms also embrace modern approaches to trial design, including the use of early safety data from overseas studies and assessments of in-silico simulations, which model how a drug may behave before being tested in patients.
These changes aim to reflect current innovation in medicine development without compromising patient safety.
Patient participation reaches new heights
Participation in clinical trials has also rebounded since the pandemic. Over 450,000 people across England took part in studies last year, highlighting the critical role of research in giving patients early access to potentially life-saving treatments.
Faster approvals and streamlined pathways mean more patients can benefit sooner from innovative therapies.
Strong regulatory performance underpins growth
The UK’s robust regulatory track record remains a key draw for global life sciences companies.
Research 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 sponsors with greater certainty and strengthens the UK’s reputation as a safe, efficient environment for high-quality clinical trials.
Driving the future of life sciences in the UK
The MHRA’s 2026 reforms are aligned with the Government’s wider strategy to modernise clinical research through the 10 Year Health Plan for England.
By cutting the time from trial application to first participant to 150 days, the UK aims to give patients faster access to new treatments while reinforcing its position as a global first choice for clinical trials.
