UK regulators use AI and process reforms to reduce clinical trial approvals from 91 to 41 days, speeding up patient access to new medicines and treatments
The UK has dramatically accelerated clinical trial approvals, reducing the average review time from 91 days to 41 days through the integration of AI and regulatory reforms. The MHRA’s new system combines advanced data analysis with human oversight, ensuring safety while enabling patients to access innovative treatments much sooner. Experts say this makes the UK a global leader in the rapid and safe approval of medical research.
Fast-tracking lower-risk trials proves successful
New findings in the British Journal of Clinical Pharmacology (BJCP) show that reforms are delivering consistently strong results, with 99% of applications reviewed within statutory timelines, and most clinical trials are completed well ahead of target.
The study is the first comprehensive review of the MHRA’s new approach to reviewing trials based on their risk level, introduced in 2023.
Implementing a fast-track route has allowed lower-risk studies to be approved in just 14 days. One example is a haemophilia A trial that was able to begin several weeks earlier than expected, giving patients with this severe bleeding disorder faster access to potentially life-changing therapy.
AI is changing how we perform clinical trials
Artificial intelligence is also playing a crucial role in accelerating the clinical trials process. AI has been introduced to support assessors’ review of complex data and improve consistency, whilst the final decisions remain with experienced assessors to ensure patient safety.
Two new bespoke MHRA AI tools are supporting clinical trial assessors in exciting new ways. The Knowledge Hub helps assessors identify common issues seen in past applications, enabling them to provide trial sponsors with more straightforward, higher-quality advice from the outset. The Good Manufacturing Practice (GMP) Compliance Checker verifies manufacturing documents in seconds, freeing up experts to focus on complex safety assessments.
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.”
Professor Andrea Manfrin, MHRA Deputy Director, Clinical Investigations and Trials, and lead author of the study, said: “The data confirms that our new approach is delivering for both patients and researchers, to create a system that is safe, faster, fairer, and more predictable. Digital innovation and risk-proportionate oversight enable lower-risk studies to move forward without unnecessary delay, while higher-risk trials continue to receive the detailed expert review they require. Researchers can know they’re in good hands, with a regulator ready to support complex, next-generation therapies – and patients can be confident that safety always comes first.”
