The Medicines and Healthcare products Regulatory Agency has set out a bold vision for the future of healthcare regulation, outlining how it will harness scientific and technological advances to improve patient outcomes across the UK by 2030.
Published today, the regulator’s new 2030 Strategy details a wide-ranging programme designed to ensure the UK remains at the forefront of developing, launching and safely using innovative medicines, medical devices and digital health technologies. The strategy also reinforces the MHRA’s core mission of delivering “health and prosperity for all, through scientific excellence”.
As healthcare continues to be transformed by artificial intelligence (AI), genomics, advanced diagnostics, and personalised medicine, the MHRA says it will modernise its regulatory approach to ensure innovation reaches patients more quickly without compromising safety.
The strategy places significant emphasis on patient-centred regulation, strengthening the use of real-world evidence, tackling illegal medicines, supporting life sciences innovation, and deepening international collaboration.
A key ambition of the strategy is to help patients gain faster access to safe and effective treatments. Planned measures include introducing an enhanced scientific advice service that will reduce turnaround times from 90 days to 45 days for medicine and medical product developers.
The MHRA also aims to halve the initial assessment target for qualifying Phase 1 clinical trials to just 14 days, while accelerating regulatory decisions on generic and biosimilar medicines to improve patient access and deliver savings for the NHS.
Recognising the growing importance of data-driven healthcare, the regulator plans to expand access to real-world data from hospitals and genomics programmes. AI will be increasingly deployed to analyse safety data, identify emerging risks earlier and strengthen post-market surveillance.
The MHRA will also simplify the Yellow Card reporting process for healthcare professionals and patients, making it easier to report adverse events linked to medicines and medical devices.
Lawrence Tallon, Chief Executive of the MHRA, said:
“We are in the midst of a period of extraordinary scientific and technological discovery, which is helping to reshape how diseases can be prevented, diagnosed and treated. AI is transforming both regulated products and how organisations are run. Cell and gene therapies are offering the possibility of long-lasting or curative treatments. Precision and personalised medicines are transforming the accuracy and effectiveness of treatments. Advanced diagnostics are driving earlier intervention and better outcomes for patients.
“These ground-breaking developments challenge traditional regulatory models and require innovative approaches to evidence generation, clinical research design, manufacturing oversight and safety and surveillance. Our 2030 Strategy sets out how, working with our partners across health and life sciences, we will translate scientific and technological innovation into better health outcomes for people across all four nations of the UK.”
The strategy highlights the MHRA’s commitment to increasing diversity in clinical research and improving health outcomes for underrepresented groups.
Plans include the launch of a Women’s Health Plan later this year, aimed at addressing inequalities in healthcare and improving outcomes for women. The regulator will also publish a refreshed Patient and Public Involvement and Engagement Plan to give patients a stronger voice in regulatory decision-making.
James Frith, Minister for Health Innovation, said:
“We want patients to benefit faster from the latest medicines and technologies, while maintaining the highest standards of safety.
“This strategy will help the MHRA keep pace with the latest innovations in AI, data and medicine, while strengthening its ability to crack down on illegal medicines to keep the public safe.
“This will put patients at the heart of regulation, whoever they are and wherever they live – with greater diversity in clinical studies and a Women’s Health Plan to secure better outcomes for women.”
Alongside supporting innovation, the regulator plans to significantly strengthen its enforcement capabilities to disrupt and prosecute those involved in the illegal trade of medicines and medical devices.
The strategy also commits to working more closely with social media platforms and online marketplaces to combat misinformation and prevent potentially harmful products from reaching consumers.
The MHRA’s roadmap includes measures designed to reduce barriers for start-ups and smaller companies, including a targeted voucher scheme to support innovation.
The regulator will also promote a transition away from animal testing towards human-relevant New Approach Methodologies (NAMs), such as organoids, while developing more flexible regulatory pathways for rare disease therapies.
A new MHRA Centre for AI and Digital Health will also be established to provide greater regulatory clarity for developers of AI-enabled medicines and medical devices.
Further plans include the development of an AI-enabled Clinical Trial Protocol Checker and the publication of an AI Medicines Development Action Plan in 2027.
International cooperation forms a central pillar of the strategy. The MHRA intends to deepen collaboration with trusted regulators, including the US Food and Drug Administration (FDA), expand recognition routes for CE-marked devices, and continue to chair the Access Consortium, which includes Australia, Canada, Singapore, Switzerland and the UK.
The agency will also establish an annual regulatory science conference aimed at bringing together researchers, regulators and industry leaders to advance innovation and strengthen the UK's international standing in life sciences.
With healthcare innovation advancing at unprecedented speed, the MHRA’s 2030 Strategy signals a clear commitment to ensuring regulation evolves alongside scientific progress, helping patients access cutting-edge treatments more quickly while maintaining robust safety standards.
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