AI is helping to speed clinical trial approval times, says MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced AI to help support clinical trial assessors to review complex data by flagging potential issues for human review. 

It is part of reforms to reduce the time it takes to approve clinical trials, which also include digital dashboards to provide real-time visibility of all active applications in the UK’s trial portfolio.

A study, published in the British Journal of Clinical Pharmacology on 6 October 2025, found that since introducing the reforms in August 2023, 99% of applications have been reviewed within statutory timelines, and most completed ahead of target.

The time it takes to approve clinical trials in the UK was cut by more than half between September 2023 and August 2024– from an average of 91 days to just 41 days.

Stephen Kinnock, health minister, 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.”

The study is the first review of the MHRA’s new way of reviewing trials based on their level of risk.

Researchers from the University of Liverpool and the MHRA reviewed more than 4,600 clinical trials’ initial applications and amendments in the first year of the MHRA’s risk-proportionate approach.

Lead author of the study, Professor Andrea Manfrin, MHRA deputy director, clinical investigations and trials, said: “Digital innovation and risk-proportionate oversight mean lower-risk studies can move ahead without unnecessary delay, while higher-risk trials still 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.”

The MHRA is also using two new bespoke AI tools: the Knowledge Hub, which helps assessors spot common issues seen in past applications, and the Good Manufacturing Practice Compliance Checker, which verifies manufacturing documents in seconds instead of hours.

Lawrence Tallon, chief executive at MHRA, 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.”

The reforms support government efforts to streamline clinical trial setup through the 10 year health plan by slashing red tape, simplifying paperwork and introducing a national standardised contract to remove delay.

Patients will be able to search for and sign up to clinical trials, via the NIHR Be Part of Research service on the NHS App, allowing them to browse and find the trials best suited to their interests and needs.