James Frith backs faster and more AI-enabled medicines regulation

The health innovation minister has endorsed a five-year MHRA strategy covering clinical trials, personalised medicine and enforcement against illegal products.

The health innovation minister has endorsed a five-year MHRA strategy covering clinical trials, personalised medicine and enforcement against illegal products.

James Frith MP. Photo: UK Parliament (official portrait).
James Frith MP. Photo: UK Parliament (official portrait).

James Frith has backed a new Medicines and Healthcare products Regulatory Agency strategy intended to give patients faster access to safe medicines and medical technology by 2030.

The regulator plans to halve its initial assessment target for qualifying phase-one clinical trials to 14 days and offer a premium scientific-advice service with a 45-day target instead of 90 days.

It will develop an AI-enabled clinical-trial protocol checker, publish an AI Medicines Development Action Plan in 2027 and create a Centre for AI and Digital Health.

The strategy also proposes greater use of hospital and genomic data to identify safety concerns, simpler Yellow Card reporting and a more flexible framework for rare-disease therapies.

Frith said the programme was intended to combine faster patient access with high safety standards. The MHRA also plans to increase criminal-enforcement capacity and work with online platforms and marketplaces against illegal medicines and medical devices.

The commitments are a multi-year regulatory programme, not immediate approvals for particular products. Delivery will depend on the regulator turning the strategy into detailed rules, services and performance measures.

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  • published this page in News 2026-10-15 13:52:54 +0100

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James Frith backs faster and more AI-enabled medicines regulation

James Frith backs faster and more AI-enabled medicines regulation