The Medicines and Healthcare products Regulatory Agency (MHRA) will use AI and NHS data to predict the side effects of drug combinations before they reach patients as part of a new study funded by the UK government.

The MHRA said the AI-driven approach will make medicines safer and bring treatments to patients more quickly.

The study is part of three projects which aim to modernise how medicines and medical technologies are tested and approved whilst still maintaining high safety standards.

The government said that millions of people in the UK take several medicines every day, with around 8.4 million people in England regularly prescribed five or more medicines.

While most combinations are safe, some can interact in ways that cause harmful side effects leading to repeated GP visits, changes to prescriptions, or hospital stays before treatments are adjusted.

Scientists from the MHRA will work with PhaSER Biomedical and the University of Dundee, to 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 MHRA said 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 to provide a reliable tool that doctors can use to better understand how combinations of medicines affect people in real life, which the MHRA said will improve how treatments are prescribed together so patients get the safest and most effective care, tailored to them, more quickly.

The regulatory agency said this personalised approach could help prevent some of the side effects linked to medicines, which are estimated to cause around one in six hospital admissions in England.

The project has been backed with £859,650 funding from the UK Government’s Regulatory Innovation Office’s AI Capability Fund.

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

Around 90 per cent of promising drugs fail late in development because early trials cannot predict how they will work in real patients. The MHRA said that by 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.

This will give regulators stronger evidence for faster decisions, bring new treatments to patients sooner, and strengthen the UK’s global position in life sciences innovation, it added.

“People are living longer and managing more conditions, often with multiple medicines, so our safety systems must keep up,” said Lawrence Tallon, chief executive of the MHRA. “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.

“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.”

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