Backed by major reforms and new digital platforms at the Medicines and Healthcare products Regulatory Agency (MHRA), the UK has reduced the average clinical trial approval time by more than half — from 91 days to just 41 days. 

The milestone was highlighted in a new study published in the British Journal of Clinical Pharmacology (BJCP), supporting the Prime Minister’s ambition to turbocharge clinical research, fast-track clinical trials and reduce set-up time to less than 150 days by March 2026.

The findings reveal that the reforms are driving consistently strong performance, with 99 percent of applications reviewed within statutory timelines and the majority completed well ahead of schedule.  A fast-track route allows some lower-risk studies to be approved in just 14 days.  

Building on this progress, artificial intelligence (AI) is now being introduced to further support assessors– helping review complex data and improve consistency – while final decisions continue to rest with experienced assessors to ensure patient safety. 

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.”

MHRA Chief Executive Lawrence Tallon noted that these reforms not only help patients access innovative treatments sooner, but also provide researchers and global companies with the certainty they need to plan and invest 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,” he stated.

Digital reforms are streamlining the UK’s clinical trial approval process through AI tools, real-time dashboards, and a unified review system.  

New MHRA AI tools — the Knowledge Hub and GMP Compliance Checker — help assessors spot issues early, improve trial design, and speed up document checks. Whie digital dashboards provide real-time visibility of all active applications, the MHRA’s Combined Review process with the Health Research Authority simplifies ethical and regulatory assessments.

Together, these tools enable faster approvals while maintaining high safety standards for complex trials like cell and gene therapies.