Following reforms backed by new digital platforms at the Medicines and Healthcare products Regulatory Agency (MHRA), the time it takes to approve clinical trials has been cut by more than half.
New research shows that it now takes just 41 days, compared to 91 days previously.
The research shows that 99 per cent of applications are reviewed within statutory timelines, and most completed well ahead of target.
The government has a goal of reducing set-up time to less than 150 days by March 2026.
The research, which was published in the British Journal of Clinical Pharmacology (BJCP), is the first comprehensive review of the MHRA’s new way of reviewing trials based on their level of risk.
A fast-track route allows some lower-risk studies to be approved in just 14 days. For example, under the 14-day notification scheme, a haemophilia A trial was able to begin several weeks earlier than expected.
AI is also being introduced to further support assessors, helping to review complex data and improve consistency.
Health minister Stephen Kinnock said: “We are halving approval times and streamlining processes, so NHS patients are at the front of the queue and receiving life-changing treatments faster than ever before.
“As we shift from analogue to digital, we are harnessing AI alongside cutting red tape and reforming bureaucratic processes so patients can receive medicines in just 41 days instead of 91.
“We are getting on with modernising our NHS for patients and making it fit for the future – because when someone is fighting for their health, every day matters.”
MHRA chief executive Lawrence Tallon said: “These reforms put patients first, helping them access innovative treatments sooner while maintaining the highest safety standards. They also give researchers and global companies the certainty they need to plan and invest here in the UK. By more than halving approval times through digital tools with proportionate oversight that prioritises patient safety, we are increasing the efficiency and attractiveness of the UK’s clinical trial ecosystem and reinforcing our global reputation as a leading destination for cutting-edge research.”
