MHRA’s 2030 Strategy plans to modernise patient-centred regulation for AI and personalised medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2030 Strategy, outlining plans to modernise medicines and medical device regulation in response to advances in artificial intelligence (AI), personalised medicine, and digital healthcare

Published on 14 October 2026, the 2030 Strategy has been made to improve patient outcomes, accelerate access to safe and effective treatments, and strengthen the UK’s position as a global leader in life sciences innovation.

The MHRA’s 2030 Strategy focuses on keeping regulations up to date with scientific developments while maintaining high standards of patient safety and public health across all four UK nations.

Faster access to innovative treatments

The plan aims to streamline regulatory processes and reduce delays for patients awaiting new treatments.

The MHRA plans to introduce a premium service that will reduce the waiting time for scientific advice from 90 days to 45 days.

The initial assessment target for qualifying Phase 1 clinical trials will also be halved to 14 days. Faster decisions on generic and biosimilar medicines are expected to improve patient access and deliver earlier savings for the NHS.

The MHRA’s 2030 Strategy also proposes a more flexible, risk-proportionate framework for rare disease therapies, helping innovative treatments reach patients more efficiently.

Using AI and real world evidence

The MHRA intends to expand its use of real-world data from hospitals and genomic research to improve regulatory decisions and identify potential safety concerns earlier.

Working with the Health Data Research Service, the agency aims to strengthen real-time safety surveillance. It will also simplify Yellow Card reporting, making it easier for patients and healthcare professionals to report suspected adverse reactions involving medicines and medical devices.

The agency will develop an AI-enabled Clinical Trial Protocol Checker to help researchers prepare higher-quality applications. An AI Medicines Development Action Plan is scheduled for publication in 2027, alongside plans to establish an MHRA Centre for AI and Digital Health.

These initiatives will clarify regulatory expectations for AI-driven medical products and develop an adaptive framework for AI as a medical device.

Putting patients at the centre

Improving representation in clinical research is another central commitment. The MHRA plans to increase diversity in clinical studies and introduce a Women’s Health Plan to address gaps in healthcare outcomes, including inequalities affecting women and different ethnic groups.

Patient involvement in regulatory decisions will also be strengthened through a refreshed Patient and Public Involvement and Engagement Plan.

Strengthening safety and supporting innovation

The strategy includes plans to expand criminal enforcement against illegal medicines and medical devices and to work with online marketplaces and social media platforms to prevent harmful products from reaching the public.

The MHRA will also support smaller companies through a targeted voucher scheme, encourage alternatives to animal testing, and expand international regulatory collaboration to reduce duplication and accelerate access to medicines and technologies.

The 2030 vision

The MHRA’s 2030 Strategy sets out an ambition to combine scientific excellence, regulatory efficiency and stronger patient involvement. Success will depend on effective collaboration across healthcare, research, industry, and international regulatory networks.

By 2030, the MHRA aims to deliver a more connected, responsive and patient-centred regulatory system that supports innovation while safeguarding public health.