UK clinical trials regulations signed into law

Major update aims to accelerate research and strengthen patient safety

New UK clinical trials regulations have been signed into law, with a 12-month rollout starting 11 April. The reforms mark the most significant update in 20 years, aiming to enhance participant safety, expedite approvals, foster innovation, and increase opportunities for people to engage in vital research.

Initially laid in Parliament in December 2024, the regulations focus on placing trial participants at the centre of clinical studies. Streamlined processes will support faster approvals and simplify testing of new treatments in the UK.

Lawrence 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.”

The MHRA plans to implement flexible and proportionate regulation, enabling quicker patient access to potentially life-saving medicines while maintaining safety standards. New provisions like Combined Review and notification schemes will now be written into law.

Janet Messer, Director of Approvals Service at the HRA, noted: “These changes reflect our commitment to making it easier to do high-quality research that people can trust.”

The regulations were shaped by feedback from patients, researchers, doctors, and industry. They aim to cut duplication, reduce bureaucracy for lower-risk trials, and make the UK a destination for international trials.

Work to embed the changes will continue with updated guidance and engagement to help sponsors and researchers navigate the transition period.