The UK is strengthening its position as a global leader in clinical trials, with new figures showing a sharp rise in activity and major regulatory reforms set to make studies faster and more efficient.
Data from the Medicines and Healthcare products Regulatory Agency reveals clinical trial applications rose by 9% between January and November 2025 compared to the same period in 2024. Growth was strongest in early-phase and innovative research, where speed and regulatory support are critical for investment decisions.
Key highlights include:
- Healthy volunteer trials up 16% – the first step in testing new medicines
- First-in-human trials up 5%
- UK-first trials up 7%, signalling growing international confidence
Developers are also seeking earlier guidance, with MHRA scientific advice meetings up 75%, helping companies design trials correctly and avoid costly delays.
From April 2026, new clinical trial regulations will introduce:
- A fast-track notification route for around 20% of lower-risk studies
- A 14-day assessment pathway for Phase 1 trials, restoring rapid approval for early testing
- Greater flexibility, including use of overseas safety data and assessment of in-silico trials
These changes aim to cut the time from application to first participant to 150 days, supporting the Government’s 10-Year Health Plan and making the UK a top destination for life sciences investment.
Patient participation is also strong, with over 450,000 people in England taking part in research last year, giving access to cutting-edge treatments.
Lawrence Tallon, Chief Executive of the MHRA, commented:
“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.”
The reforms build on the MHRA’s track record, with 99% of applications reviewed on time, most ahead of schedule, according to research published in the British Journal of Clinical Pharmacology.
The UK’s offer is clear: a faster, more innovative clinical trial environment, backed by world-class safety standards and regulatory excellence.
Image credit: iStock
