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The Medicines and Healthcare products Regulatory Agency (MHRA) has published its Strategy to 2030, outlining plans to modernise regulation in response to advances in artificial intelligence (AI), personalised medicines, and healthcare technology.
Published on 14 October 2026, the strategy sets out the agency’s ambition to improve patient outcomes, support faster access to safe and effective treatments, strengthen the use of data, and reinforce the UK’s position in life sciences.
Putting Patients at the Centre of Regulation
The MHRA’s strategy focuses on making regulation more patient-centred while maintaining high standards of safety and effectiveness.
The agency aims to strengthen patient involvement in regulatory decisions, improve diversity in clinical studies, and introduce a Women’s Health Plan to address health gaps and improve outcomes for women.
The strategy also emphasizes greater transparency and improved access to information to support healthcare decisions.
Strengthening Safety Through Data and Real-World Evidence
The MHRA plans to expand the use of real-world data from sources including hospitals and genomics to support regulatory decisions and identify potential safety issues earlier.
The strategy includes using AI to analyse real-world data and working with the Health Data Research Service to support real-time safety surveillance.
The agency also plans to simplify Yellow Card reporting of adverse events involving medicines and medical devices for patients and healthcare professionals.
Modernising Regulation for AI and Digital Health
AI and digital technologies are central to the MHRA’s plans for regulatory modernisation.
Key commitments include:
- Developing an AI-enabled Clinical Trial Protocol Checker to support regulatory certainty and higher-quality clinical trial applications.
- Publishing an AI Medicines Development Action Plan in 2027.
- Establishing an MHRA Centre for AI and Digital Health.
- Developing a modern regulatory framework for AI as a medical device.
These initiatives are intended to clarify regulatory expectations and support the safe development and use of AI-driven medicines and medical technologies.
Faster Regulatory Decisions and Access to Innovation
The strategy also sets targets to improve the speed of regulatory services.
The MHRA plans to introduce a higher-value scientific advice service that reduces the target timeframe from 90 days to 45 days. It also aims to halve the initial assessment target for qualifying Phase 1 clinical trials to 14 days.
Additional commitments include faster decisions on generic and biosimilar medicines to support earlier patient access.
Supporting Innovation in Medicines Development
- Promote human-relevant NAMs, such as organoids, as alternatives to animal testing.
- Introduce targeted vouchers to reduce regulatory barriers for start-ups and small companies.
- Develop flexible, risk-proportionate pathways for rare disease therapies.
- Strengthen links between UK genomics capabilities, the NHS, and the MHRA.
Transform Regulation Through AI and MedTech
- Develop an AI-enabled Clinical Trial Protocol Checker to improve application quality and regulatory certainty.
- Publish an AI Medicines Development Action Plan in 2027.
- Establish an MHRA Centre for AI and Digital Health to clarify regulatory expectations.
- Create a modern, adaptive regulatory framework for AI as a medical device.
International Regulatory Collaboration
International cooperation is another priority in the MHRA’s 2030 Strategy.
The agency plans to expand reliance and recognition routes with trusted regulators, including collaboration with the US Food and Drug Administration (FDA) and continued recognition of CE-marked medical devices.
It also intends to work through Regulatory Innovation Corridors to reduce duplication and support progress towards clinical studies, while continuing to chair the Access Consortium involving Australia, Canada, Singapore, Switzerland, and the UK.
Regulatory Affairs and Pharmacovigilance in an Evolving Landscape
The strategy highlights the importance of adapting regulatory approaches as AI, real-world data, and personalised medicines develop.
These areas are relevant to pharmaceutical regulatory affairs and pharmacovigilance, where regulatory requirements, product safety monitoring, and supporting documentation remain important throughout the product lifecycle.
Baupharma’s Regulatory Affairs & Market Entry and Pharmacovigilance Services cover related regulatory and medicine-safety activities.
Conclusion
The MHRA’s Strategy to 2030 sets out a programme to modernise regulation through patient-centred decision-making, stronger use of data, faster regulatory services, and clearer pathways for AI and personalised medicines.
Its commitments also address clinical research, rare disease therapies, international cooperation, and the ongoing monitoring of medicine and medical device safety.
The strategy establishes the agency’s priorities through 2030 as it seeks to keep regulation aligned with scientific and technological developments while protecting public health.
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