Patients receive earlier access to life-saving treatments as UK trial approval times cut in half from 91 to just 41 days.
The time it takes to approve clinical trials in the UK has been cut by more than half — from an average of 91 days to just 41 — following major reforms and the rollout of new digital tools at the Medicines and Healthcare products Regulatory Agency (MHRA).
This breakthrough means patients can access promising new treatments, including advanced cancer and rare disease therapies, several weeks earlier than before. The faster approvals support the Prime Minister’s ambition to accelerate clinical research and cut overall trial setup times to under 150 days by March 2026.
According to findings published in the British Journal of Clinical Pharmacology on 6 October, 99% of all clinical trial applications are now being reviewed within statutory timelines, with most completed well ahead of schedule. The analysis — the first major review of the MHRA’s new risk-based approach to trial assessment introduced in 2023 — found that reforms are delivering faster approvals while maintaining strict safety standards.
A new fast-track route allows lower-risk studies to begin within just 14 days. For example, a haemophilia A trial launched weeks ahead of schedule under this system, giving patients faster access to potentially life-changing therapy.
Artificial intelligence is now helping MHRA assessors review vast volumes of complex data quickly and consistently. AI tools such as the Knowledge Hub and GMP Compliance Checker speed up analysis by highlighting potential issues, checking manufacturing compliance, and freeing expert reviewers to focus on safety and science.
Meanwhile, real-time digital dashboards track all active UK applications, ensuring transparent and predictable timelines. The MHRA’s Combined Review process with the Health Research Authority also streamlines ethical and regulatory approvals, reducing duplication and red tape for researchers.
Health Minister Stephen Kinnock said:
“We are halving approval times so NHS patients are at the front of the queue for life-changing treatments. Harnessing AI and digital innovation means medicines can be approved in 41 days instead of 91. Every day saved makes a difference when someone is fighting for their health.”
MHRA Chief Executive Lawrence Tallon added:
“These reforms put patients first, giving them faster access to innovative treatments while maintaining the highest safety standards. By using digital tools and proportionate oversight, we’re boosting the UK’s global reputation as a destination for cutting-edge research.”
The MHRA’s new approach has already reviewed over 4,600 trial applications and amendments, with nearly all completed within target timelines. The agency’s study, conducted with the University of Liverpool, confirms that digital transformation and smarter regulation are creating a system that is “safe, faster, fairer, and more predictable.”
New legislation taking effect in April 2026 will embed these reforms further. All UK trials will need to be publicly registered, with results published in plain language to strengthen trust and encourage participation. Sponsors will also have more flexibility, with extended deadlines to respond to feedback — helping align the UK with international research standards.
Together, these changes mark a major step forward for UK science, positioning the nation as a global leader in clinical research — combining speed, certainty, and innovation with the highest standards of patient safety.
Source: Health & Social Care
