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MHRA to launch AI sandbox for medicines development and testing

The Medicines and Healthcare products Regulatory Agency has announced plans to launch a regulatory AI sandbox with the aim to explore how artificial intelligence can support medicines development and safety.

The sandbox, funded by the Regulatory Innovation Office, will enable AI tools to be tested that have the potential to predict how medicines will be absorbed, processed, or whether they may cause harm. The sandbox will also be used to inform the MHRA about the reliability of whether AI tools can support in deciding the safety of new medicines.

MHRA will use insights from the programme to evaluate the reliability of AI-enabled approaches, with this work expected to contribute to the development of a stronger evidence base and clearer guidance for the safe use of AI within medicines development.

Up to five AI-driven approaches will be tested during the first phase, with the agency to begin working with industry and academic partners from Summer 2026.

The initiative will also explore how clinical data can be used more effectively to improve understanding of medicine performance across different population groups.

Wider trend: AI 

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