Key points from article :
The United Kingdom has introduced new regulations to make clinical trials faster and simpler, aiming to boost its role in international medical research. The updated law, based on the 2004 Medicines for Human Use (Clinical Trials) regulations, entered a one-year rollout phase on April 11, 2025, and will come fully into force by April 10, 2026.
One major change is the legal adoption of the "combined review" system, where researchers can apply for both ethics and regulatory approvals at once through the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA). This is expected to speed up approval times, aiming for a two-week turnaround for low-risk trials.
These reforms were proposed after independent reviews highlighted a sharp drop in patient recruitment and called for an overhaul to strengthen the clinical trial environment in the U.K. The government's goal is to cut the time it takes to enroll the first participant after applying for a trial from 250 days to just 150 days.
In addition to speeding up trial approvals, the United Kingdom government, along with the Wellcome Trust, has committed £600 million to create a new health data research service that will improve researchers' access to National Health Service (NHS) data. The hope is that better access to data will encourage more clinical studies and faster innovation.
The Health Research Authority (HRA) will also release further guidance in the coming months to help researchers adapt to the new rules. These changes are part of a broader effort to make Britain a global hub for medical research and innovation.
