The Medicines and Healthcare products Regulatory Agency (MHRA) has launched three government-funded initiatives that aim to make medicine development and regulation safer and more efficient through the use of artificial intelligence (AI). Among these projects is a pioneering study focused on predicting harmful side effects that arise from interactions between multiple drugs before they reach patients.
In England, around one in seven people, or approximately 8.4 million individuals, are prescribed five or more medications. While most drug combinations are safe, certain interactions can cause unexpected side effects, leading to repeated medical visits, treatment adjustments, or even hospitalization. These complications not only affect patients’ quality of life but also create a heavy burden on the NHS. It is estimated that adverse drug reactions account for one in six hospital admissions and cost the NHS over £2 billion each year.
To address this growing challenge, the MHRA is collaborating with PhaSER Biomedical and the University of Dundee to develop AI tools capable of detecting potential side effects caused by drug combinations. The project, supported by £859,650 in funding from the government’s Regulatory Innovation Office through its AI Capability Fund, will analyze anonymized NHS data to identify how different medicines, especially cardiovascular drugs interact when taken together.
The AI system will be designed to recognize patterns in real-world data that may indicate harmful drug interactions. These findings will then be validated in laboratory studies using human-relevant models of drug metabolism.
The ultimate goal of the project is to create a decision-support tool for healthcare professionals. This tool will help clinicians better understand complex drug combinations, allowing them to prescribe medicines more safely, effectively, and in a way that is tailored to individual patient needs. This could significantly reduce the frequency of adverse reactions, hospitalizations, and the overall healthcare costs associated with polypharmacy, the use of multiple medications by a single patient.
In addition to this main project, the MHRA has secured further funding to advance AI in regulatory science. The agency received £1 million for the ARISE program (AI for Regulatory Insight, Safety and Efficiency), which will focus on integrating AI to enhance the agency’s decision-making processes and regulatory evaluations. Another £259,250 has been allocated to explore the use of synthetic patient data in clinical trials targeting cancer, inflammatory conditions, and rare pediatric diseases.
Together, these initiatives represent a major step forward in using AI and data-driven methods to transform how medicines are developed, tested, and approved.
Learn more: Side effects from drug interactions to be predicted by AI before reaching patients
