MHRA launches AI sandbox to improve medicines safety

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to launch a new AI regulatory sandbox aimed at improving medicines safety and accelerating the development of new treatments.

The initiative, unveiled by Science Minister Lord Vallance on 9 June 2026, will provide companies and researchers with a controlled environment to test AI tools designed to predict how medicines may perform in people and identify potential safety risks earlier in the development process.

Through the sandbox, the MHRA will work with industry and academic partners to assess whether AI can improve medicines safety assessment and identify risks that traditional methods may miss.

Unlike the AI Airlock programme, which focuses on AI medical devices, the new sandbox will support the testing of AI tools used in medicines development and safety assessment.

Up to five AI technologies will be tested during the first phase of the programme, with work due to begin in summer 2026.

Lawrence Tallon, chief executive at the MHRA, said: “We’re seeing extraordinary advances in AI and biomedical science. The opportunity now is to harness them to deliver real benefits for patients.

“These technologies could help us understand medicines better, generate stronger evidence on their safety, and accelerate the development of innovative treatments, especially in areas of unmet need.

“For patients, that means greater confidence that the medicines they rely on are supported by the best available science, with evidence that better reflects the diverse range of people they are intended to treat.”

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Source: Digital Health, 16 June 2026