MHRA targets medicine safety with new AI sandbox

The Medicines and Healthcare products Regulatory Agency (MHRA) is launching a new initiative to establish how artificial intelligence (AI) can improve the safety of medicines and aid related decisions.

The new regulatory ‘sandbox’ will provide companies and researchers with a controlled testing ground in which to test AI tools alongside regulators.

Specifically, how the technology can improve the accuracy and safety assessment of medicines and better predict their risks and side effects. Moreover, how reliable they are in medicine safety. Ultimately, stronger evidence provides companies with more confidence to invest in innovation in the UK.

UK Health Innovation Minister Preet Gill said: “By giving innovators a safe space to test these tools alongside regulators, we can build the evidence base needed to get safer, more effective treatments to patients faster. That means fewer adverse reactions, less reliance on animal testing, and a smarter, more efficient medicines development process.”

“By giving innovators a safe space to test these tools alongside regulators, we can build the evidence base needed to get safer, more effective treatments to patients faster”

UK Health Innovation Minister Preet Gill 

The initiative will also explore how better use of clinical data can improve understanding about how medicines work across different groups, including those in underrepresented patient populations.

In the first phase of the sandbox, the MHRA will test a maximum of five AI-driven approaches. This summer, the MHRA will collaborate with participating industry and academic partners to shape operational parameters of the initiative.

MHRA Chief Executive Lawrence Tallon said “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. By working directly with developers and researchers, we can help create the right environment for innovation to thrive and cement the UK’s position as a world leader in life sciences.”

This sandbox strengthens the UK’s plans to deliver alternatives to animal testing. It builds on the EU Commission’s recent roadmap delineating its approach to phasing out the use of animals in chemical safety assessments.

Moreover, in January, the European Commission issued a joint guidance with the US FDA to advance the use of AI in drug development.

Professor Chris Molloy, CEO of the BioIndustry Association (BIA), commented that “AI models have the potential to derisk drug development and deliver them to patients faster. But they need to be taught, tested and proven in a rigorous, safe space – which [the MHRA’s new] sandbox delivers.”