The latest update from the MHRA and UK Government shows continued momentum in UK clinical research, with rising trial numbers and new regulatory changes set to make it easier and quicker to get trials underway.
Alongside recent increases in clinical trial applications, early-phase studies and scientific advice meetings, new regulatory changes coming into effect from April 2026 are likely to make the UK an even more attractive place to run trials.
MHRA figures comparing January to November 2025 with the same period in 2024 show:
- A 9% increase in clinical trial applications
- A 16% increase in Phase I trials with healthy volunteers
- A 75% increase in scientific advice meetings, as companies look to engage earlier with regulators and avoid delays
These trends point to growing confidence in the UK’s clinical research environment.
From April 2026, reforms to the UK clinical trials framework will introduce:
- A fast-track notification route for lower-risk studies, helping them speed up the full approval process
- A 14-day maximum assessment timeline for Phase I trials, giving Sponsors greater speed and predictability
- A shift toward a more agile, proportionate approach to regulation, aligned with how modern medicines are developed today
“These changes are really positive and show just how committed the UK is to supporting clinical research,” says Claire Horsgood, Vice President of Operations and Growth at MAC.
“With faster approvals and a clear focus on early-phase studies, the UK remains a great place to run trials, especially for Sponsors looking to move quickly.”
More than 450,000 people in England took part in clinical research last year, an 18% increase from 2024, demonstrating the real-world impact of faster start-up and improved trial access. For many patients, particularly those with limited treatment options, these changes could mean earlier access to cutting-edge therapies.
These reforms as a strong step forward, not just in reducing start-up timelines, but in creating a more joined-up, efficient system that benefits both patients and Sponsors.
Read the UK Government announcement in full here.
