MHRA publishes 2030 Strategy with AI commitments for medicines and medical device regulation
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Summary
The Medicines and Healthcare products Regulatory Agency published its 2030 Strategy on Oct 14, 2026, setting out plans to modernise regulation across the UK. Commitments on AI include developing an AI-enabled Clinical Trial Protocol Checker, publishing an AI Medicines Development Action Plan in 2027, establishing an MHRA Centre for AI and Digital Health, and creating a modern, adaptive regulatory framework for AI as a medical device. The strategy also covers using AI to analyse real world data to identify safety issues earlier, faster scientific advice, a Women's Health Plan, tougher enforcement against illegal medicines, and closer collaboration with regulators including the US FDA.
Why it matters
The strategy signals how the UK medicines and devices regulator intends to approach AI-driven products and its own use of AI. Developers of digital and AI-driven medical devices and medicines are told to expect clearer regulatory expectations, a dedicated centre and a new framework for AI as a medical device.
- Parties involved
- Medicines and Healthcare products Regulatory Agency; Department of Health and Social Care; Health Research Authority
- Primary source
- GOV.UK (gov.uk)
Source retrieved: . Sources are often in other languages; links open the original. - Topics
- Healthcare & medical AI · General AI governance