New regulations for clinical trials in the United Kingdom have been signed. A 12 -month deployment begins since mid -April to offer the most significant update of the regulation of clinical trials in the United Kingdom in two decades, with the aim of strengthening patient safety, accelerating approvals, allowing innovation and helping more people benefit from people benefit from people who benefit from people benefits in the benefit of people.
The updated regulations are designed to put the interests of the participants firmly in the center of how the trials are executed, while supporting the fastest and faster and simplified approval, which facilitates the test of new treatments in the United Kingdom.
The Medical Care and Products Regulatory Agency (MHRA) undertakes to implement a flexible regulation and provided by the risk of clinical trials, which accelerates the patient access to potentially saving medications without compromise.
The new regulations will have a full effect as of April 10, 2026. They were developed by MHRA, in association with the Health Research Authority (HRA), and formed by the feedback of patients, researchers, doctors and industry.
The reforms will put the patients and their safety in the focus of all clinical trials and will bring the benefits of clinical trials to all; Cut the duplication and unnecessary delays, while maintaining a solid supervision of the safety of the tests; Create a regulatory environment provided and flexible, reducing bureaucracy for lower risk tests; He cements the United Kingdom as a destination for international evidence and provides a framework that is simplified, agile and receptive to innovation.
By reducing bureaucracy and simplifying approvals, the new framework supports the objective of the United Kingdom Prime Minister to reduce the application time to the first participant from 250 to 150 days. It will accelerate the research and reduce the time that takes promising treatments to reach patients, without compromising safety.
(Source: MHRA)
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Posted on April 20, 2025
