United Kingdom has marked a sharp rise in research activity and major regulatory reforms aimed at accelerating study approvals, strengthening its position as a global destination for clinical trials. New data released on January 13 by the Medicines and Healthcare products Regulatory Agency (MHRA) shows clinical trial applications increased by 9 percent between January and November 2025 compared with the same period in 2024.
Growth was particularly strong in early-stage and innovative research. Trials involving healthy volunteers rose by 16 percent, first-in-human studies increased by 5 percent, and trials being conducted in the UK for the first time grew by 7 percent, reflecting rising international confidence in the UK’s clinical research ecosystem.
From April, a new set of clinical trial regulations will introduce significant reforms, including a fast-track notification route expected to cover around 20 percent of lower-risk studies. This pathway will allow trials to begin sooner while maintaining robust safety standards. In parallel, the MHRA will roll out a 14-day assessment route for Phase I trials, restoring a rapid approval pathway for early human testing.
The updated framework will also support innovation by enabling better use of overseas safety data that meets UK standards and allowing the assessment of computer-based simulations, such as in-silico trials. These measures are designed to reflect modern drug development practices without compromising patient safety.
Patient participation in research has also rebounded, with more than 450,000 people in England taking part in clinical studies last year.
The UK’s regulatory performance remains strong, with 99 percent of clinical trial applications reviewed on time, according to research published in October 2025. The reforms are being promoted internationally as UK health leaders engage with global life sciences companies and investors, reinforcing the country’s ambition to be a fast, safe and innovation-friendly environment for clinical research.
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