UK Medicines Regulator Plans AI Safety Tools by 2030

Oct 15, 2026
The MHRA plans to use AI to detect medicine safety signals earlier, improve clinical trial applications and clarify rules for AI medical products.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to use AI to identify medicine safety signals earlier under its 2030 Strategy, according to The Pharmaceutical Journal. The strategy was published on October 14, 2026.

The regulator will work with the Health Data Research Service to use NHS data and real world evidence in product safety monitoring. It will also simplify Yellow Card reports through a conversational interface and digital services such as the NHS App.

The MHRA will establish a Centre for AI and Digital Health to clarify requirements for AI medicines and medical devices. It also plans to publish an AI medicines development action plan in 2027 and create an AI based Clinical Trial Protocol Checker to help researchers prepare applications.

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