The British Journal of Clinical Pharmacology analysis, conducted by the MHRA in collaboration with the University of Liverpool, reviewed more than 4,600 clinical trials initial applications and amendments in the first year of the MHRA's risk-proportionate approach, launched with patient input in August 2023. Almost all initial applications (99%) were completed within the statutory 30-day timeframe and 99.9% of amendments within 35 days – with many decisions delivered well ahead of target.
AI is helping support clinical trial assessors, scanning thousands of pages of data to flag potential issues for human review, and two new bespoke MHRA AI tools are taking this further. The Knowledge Hub helps assessors spot common issues seen in past applications, so they can give trial sponsors clearer, higher-quality advice from the start – helping well-designed trials get underway sooner. The Good Manufacturing Practice (GMP) Compliance Checker verifies manufacturing documents in seconds instead of hours, freeing up experts to focus on complex safety assessments.
Meanwhile, digital dashboards provide real-time visibility of all active applications in the UK's trial portfolio, helping the MHRA track performance and deliver more predictable timelines.
The MHRA's Combined Review process with the Health Research Authority runs ethical and regulatory assessments in parallel, cutting duplication for researchers and industry, offering a single, streamlined route into the UK system.
In addition, millions of people will also be able to search for and sign up to clinical trials, via the NIHR Be Part of Research service on the NHS App, allowing patients to browse and find the trials best suited to their interests and needs.
Professor Andrea Manfrin, MHRA deputy director of 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 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.'
Professor Sir Munir Pirmohamed, co-author of the study at the University of Liverpool, said: ‘This is excellent news for trialists and for patients getting access to innovative medicines. It is always going to be important to continually review how well the system is working, ensuring that patient safety is the foremost priority in the assessment of the clinical trial applications.'
New legislation coming into force in April 2026 will embed these reforms further. All UK clinical trials will be required to publicly register and publish their results, including easy-to-read summaries for participants. This means for the first time patients will be able to see, in plain language, what a study found – a move that could help strengthen trust in science and encourage more people to take part in research.
The legislation will also give sponsors more flexibility, by extending the deadline to respond to regulator feedback from 14 to 60 days – helping align with international trial timelines.
