Government funding has been announced for three Medicines and Healthcare products Regulatory Agency (MHRA) projects using AI to make medicines safer and bring treatments to patients more quickly.
One study will use AI and NHS data to predict side effects from drug combinations before they reach patients.
In England, around 1 in 7 people (8.4 million) are regularly prescribed five or more medicines. While most combinations are safe, some can interact in ways that cause harmful side effects. Side effects from medicines are estimated to cause around one in six hospital admissions in England and cost the NHS more than £2 billion every year.
Scientists from the MHRA, working with PhaSER Biomedical and the University of St Andrews will use AI to help spot these interactions. The system will look for patterns in anonymised NHS data showing how different medicines behave when used together, focusing on cardiovascular medicines.
The results will then be tested in a lab using human-based models that mimic how drugs are processed in the body.
The study is backed by £859,650 funding from the UK Government’s Regulatory Innovation Office’s AI Capability Fund.
The tool could also help change are how new medicines are discovered and tested. Stats show that around nine in ten promising drugs fail late in development because early trials can’t always predict how they’ll work in real patients. However, using AI and real-world health data that reflect the diversity of patients and how they take medicines, scientists can spot risks and successes earlier, giving regulators stronger evidence for faster, well-informed decisions. This could cut delays and costs for developers, bring new treatments to patients sooner, and strengthen the UK’s global position in life sciences innovation.
Another project has been awarded £1,000,000 via the Regulators’ Pioneer Fund to pilot the use of AI-assisted tools to support experts in scientific advice, clinical trial assessments and licensing decisions. This will aim to improve efficiency and consistency while keeping all final decisions in human hands. The AI for Regulatory Insight, Safety, and Efficiency (ARISE) programme will demonstrate how regulators can responsibly use AI to strengthen medicine safety, streamline the development of new treatments and enable faster access to new therapies.
The third project will pilot the use of synthetic (artificial) patient data to support clinical trials in cancer, inflammatory bowel disease and rare paediatric seizure conditions. This has been funded with £259,250 from the Regulators’ Pioneer Fund. The project will test how synthetic data can safely and responsibly supplement evidence for regulatory decisions.
Lawrence Tallon, chief executive of the MHRA, said: “People are living longer and managing more conditions, often with multiple medicines, so our safety systems must keep up. By using new tools and real-world health data, the MHRA is delivering practical solutions that protect patients and speed access to effective treatments, making regulation safer, smarter and more inclusive. Government backing lets us drive this work forward and set an example internationally. Together with piloting new approaches to improve consistency and efficiency across the regulatory lifecycle, from early advice to licensing, we will show how modern regulation can deliver for patients and the life sciences sector.”
Julian Beach, interim executive director healthcare quality and access at the MHRA, supervising the study, said: “The launch of this project will demonstrate how AI and advanced modelling can be built into drug development to design smarter, more efficient clinical trials. By understanding how medicines work together, we can generate stronger, more realistic evidence to support new treatments and ultimately reduce avoidable harm. We encourage researchers and industry to share pilot data, methods or ideas, and get in touch with us early so we can work together to develop these approaches and shape the next generation of clinical trials.”
