The goal is to create a more streamlined and agile regulatory environment that reduces bureaucracy while maintaining robust oversight of patient safety
The government has taken a significant step forward in modernising its clinical trials regulations with the introduction of new laws aimed at strengthening patient safety, accelerating approvals, and fostering innovation. The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the new regulations will be implemented over a 12-month period, starting on 11 April 2025, and will take full effect from 10 April 2026. This marks the most substantial update to the UK’s clinical trials regulation in over two decades.
The updated regulations were first introduced in Parliament in December 2024. They have been developed by the MHRA in partnership with the Health Research Authority (HRA) and shaped by feedback from patients, researchers, doctors, and industry stakeholders. The goal is to create a more streamlined and agile regulatory environment that reduces bureaucracy while maintaining robust oversight of patient safety.
The new regulations focus on several key areas. They prioritise a patient-centric approach, ensuring that participants are at the centre of trial management and that their well-being is paramount. This approach aims to bring the benefits of clinical trials to a broader audience and enhance patient safety.
The regulations also streamline the approval process by reducing duplication and unnecessary delays. This is achieved through simplifying the regulatory framework and cutting red tape, which speeds up research and reduces the time it takes for promising treatments to reach patients.
A proportionate and flexible approach is introduced, especially for lower-risk trials. This reduces bureaucratic hurdles and makes it easier to test new treatments in the UK. The reforms are also designed to enhance the UK’s appeal as a leading destination for international clinical trials by creating a more streamlined and agile regulatory environment, thereby attracting more global research projects.
Additionally, the Combined Review system, which allows researchers to apply for ethics and regulatory approval simultaneously, will now be written into law. This further streamlines the approval process and reduces the time from application to the first participant.
The 12-month implementation period will be supported by updated guidance and ongoing engagement with trial sponsors and researchers. The MHRA and HRA will work closely with stakeholders to ensure a smooth transition to the new regulations.
Lawrence Tallon, Chief Executive of the MHRA, emphasised the importance of these changes: “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.”
Janet Messer, Director of Approvals Service at the HRA, added: “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.”
The new regulations are expected to have a significant impact on the UK’s research and innovation landscape. By reducing the time from application to the first participant from 250 to 150 days, the new framework supports the Prime Minister’s target to accelerate medical breakthroughs. This will not only speed up the availability of new treatments but also make the UK more attractive for international trials.
The reforms are also expected to benefit patients by providing them with earlier access to potentially life-saving treatments. The MHRA’s commitment to a flexible and risk-proportionate regulatory approach ensures that patient safety remains uncompromised while accelerating the approval process.
