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The Medicines and Healthcare products Regulatory Agency (MHRA) has said it will use artificial intelligence (AI) to identify potential medicines safety issues earlier, simplify Yellow Card reporting and ensure all product information is available digitally by 2030.
In its 2030 strategy, published on 14 October 2026, MHRA also commits to working with the Health Data Research Service — a national body set up in 2025 to give researchers and regulators secure access to NHS health data — to give the regulator “a more comprehensive view of product safety in real-world use”.
The MHRA also plans to establish a Centre for AI and Digital Health to clarify regulatory expectations for developers of AI-driven medicines and medical devices, as well as publish an AI medicines development action plan in 2027 for the “safe and effective use of AI”.
The strategy pledges to make the MHRA’s Yellow Card scheme for adverse event reporting “simpler and quicker for users to submit information” on medicines and medical devices, by introducing a “more conversational interface” and making it available through digital tools, such as the NHS App.
In addition, the regulator plans to “modernise” how information about medicines and devices reaches patients and clinicians.
It says patient information leaflets “remain largely paper-based”, adding that by 2030, the MHRA aims for “all product information to be available as structured digital content”, which will be accessible through digital tools and services, while paper and braille formats will be retained for those who need them.
The regulator has also committed to “substantially increase” its criminal enforcement capacity to tackle illegal medicines and medical devices, as well as to work with social media platforms and online marketplaces to combat misinformation and “prevent harmful products from reaching the public”.
Geraldine McCaffrey, director for Wales at the Royal College of Pharmacy, told The Pharmaceutical Journal that the MHRA’s focus on using AI and real-world data to identify safety signals “could strengthen medicines safety and help regulators respond more quickly to emerging risks”.
“As AI becomes more embedded across healthcare and medicines development, it is important that pharmacy professionals are involved in shaping how these technologies are implemented,” she added.
“We need to be confident that AI is safe, reliable and being used appropriately, with clear accountability and meaningful human oversight. AI should enhance professional expertise and judgement, not replace it, with patient safety remaining the priority.”
The Association of the British Pharmaceutical Industry (ABPI) backed the MHRA’s strategy, stating that it addressed priorities that it had set out in its December 2024 report, which called for faster, more predictable regulatory decisions and closer working between the MHRA and the National Institute for Health and Care Excellence (NICE).
Richard Torbett, chief executive of the ABPI, commented: “In 2024, our industry set out a clear ambition for the MHRA: to be among the best in the world at both regulating innovation and innovating regulation. This strategy matches that ambition and, in many areas, goes further.
“The MHRA’s new strategy is clear on speed, clear on standards and clear on how performance will be measured, with firm service guarantees, closer working with NICE and patients at the centre of every decision.”
