The study is among three MHRA projects, backed by government funding, to modernise how medicines and medical technologies are tested and approved.

Scientists from the MHRA, working with PhaSER Biomedical and the University of St Andrews, and backed with £859,650 funding from the UK Government's Regulatory Innovation Office's AI Capability Fund – which supports regulators to test new, faster ways of bringing safe innovation – will use AI to help spot drugs interactions. The system will look for patterns in anonymised NHS data showing how different medicines behave when used together, focusing on cardiovascular medicines. These signals will then be tested in the lab using human-based models that mimic how drugs are processed in the body.

The goal is a reliable tool that doctors can use to better understand how combinations of medicines affect people in real life, improving how treatments are prescribed together so patients get the safest and most effective care, tailored to them, more quickly. 

In addition, the tool could transform how new medicines are discovered and tested. 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. 

The project will also produce practical guidance for developers on using AI and real-world data alongside traditional trial evidence, helping the field develop.

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, who is supervising the study, added: ‘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.'

The MHRA will also pilot the use of AI-assisted tools to support experts in scientific advice, clinical trial assessments and licensing decisions. The system aims to improve efficiency and consistency while keeping all final decisions in human hands.

Funded by £1,000,000 via the Regulators' Pioneer Fund, 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 programme also contributes to the goals of the Life Sciences Sector Plan to create faster, risk-proportionate, and predictable routes to regulatory approval.

Another MHRA project will pilot the use of synthetic (artificial) patient data to support clinical trials in cancer, inflammatory bowel disease and rare paediatric seizure conditions. Previous work suggests synthetic data can be used to strengthen the evidence from clinical trials in rare and underrepresented populations with smaller patient populations. This project will involve a regulatory sandbox that helps translate this into regulatory policy. 

Funded by £259,250 from the Regulators' Pioneer Fund, this work will test how synthetic data can safely and responsibly supplement evidence for regulatory decisions.

The findings of the three projects will help shape the next generation of clinical trials and approvals and inform upcoming guidance, including the MHRA's National Commission into the Regulation of AI in Healthcare, which brings together patient advocates, clinicians, regulators, and technology companies to advise the MHRA on AI regulation in healthcare.

The work also supports the government's ambition to make the UK the most AI-enabled health system in the world, delivering highly personalised care as set out in the 10 Year Health Plan for England, and reinforcing the UK as a global hub for life sciences innovation under the Life Sciences Sector Plan.