On June 9, 2026, the United Kingdom launched an initiative to test how artificial intelligence (AI) can help make medicines safer for patients through a regulatory “sandbox.” The program will explore how AI can improve the assessment of accuracy and safety, better predict risks, and detect effects that existing approaches might miss.
The sandbox will allow for the testing of AI tools to predict how medicines behave in the body, including absorption, metabolism, and potential toxicity. The program will also explore how to optimize the use of clinical data to better understand how medicines work in different populations, including those often underrepresented in studies, such as children, older people, and minorities.
This is part of a broader effort to modernize medicines development by addressing the known limitations of traditional development models to improve how medicines safety and efficacy are assessed.
In the first phase, up to five AI-driven approaches will be tested. The MHRA will begin collaborating with partners from industry and academia starting in the summer of 2026 to define how the sandbox will operate.
This initiative positions the United Kingdom at the forefront of regulatory innovation integrated with AI, enabling faster validation of emerging methodologies and defining future regulatory expectations regarding the use of AI.
SOURCE:
https://www.gov.uk/government/news