United Kingdom, 11 April 2025: The UK has begun a 12-month rollout of the most significant reform to its clinical trial regulations in over two decades. Signed into law, the new framework aims to enhance patient safety, speed up approvals, and make the UK a more attractive location for medical research.
Created jointly by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA), the updated regulations focus on protecting trial participants while simplifying procedures to minimize delays and cut unnecessary bureaucracy, particularly for trials considered low-risk.
Based on extensive consultation with patients, researchers, and industry experts, the updated system introduces:
- A stronger focus on patient safety and experience.
- Faster, more flexible approvals without compromising oversight.
- Reduced bureaucracy to support innovation.
- Incorporation of the Combined Review and notification scheme into law to simplify and streamline the application process.
The reforms support the UK government’s goal of cutting trial start times from 250 to 150 days and will take full effect on 10 April 2026.
This overhaul marks a major step forward in making the UK a leader in global clinical research, while ensuring new treatments reach patients faster and more safely.In a government press release published on www.gov.uk , Lawren Tallon, MHRA Chief Executive, said: “These new regulations are a key step towards a stronger, more responsive and risk-proportionate clinical trials system that works better for patients. They will help ensure people in the UK can benefit sooner from safe, carefully assessed research into new potentially life-saving medicines, while maintaining the highest standards of participant safety.
“By streamlining how trials are approved and run, we are making the UK a more attractive place to deliver high-quality, innovative research. I’d like to thank colleagues across the MHRA, HRA, government, industry and the clinical research community who helped shape these changes. We’ll continue to work closely with our partners through the implementation period.”
In the same press release, Janet Messer, Director of Approvals Service at the Health Research Authority, said: “This is an important milestone in improving how clinical trials are set up and run in the UK. By embedding Combined Review in law, and strengthening the focus on transparency and proportionality, these changes reflect our commitment to making it easier to do high-quality research that people can trust.
“We’ve worked closely with patients, researchers and partners across the system to ensure the new regulations protect participants, while reducing unnecessary burden.
“In the coming months we’ll be publishing guidance to accompany the new regulations to support researchers through the transition period and beyond, so more people can benefit from taking part in safe, well-run research.”
The UK has launched a major reform of its clinical trial regulations, aiming to enhance patient safety, streamline approvals, and boost innovation. Taking full effect by April 2026, the new framework is designed to reduce red tape, accelerate trial start times, and make the UK a leading hub for global medical research.
