MHRA 2030 Strategy to modernise patient-centred regulation for the era of AI and personalised medicines

Commitments made in the strategy will enable the regulator to keep pace with rapid advances in science, technology and personalised healthcare, to benefit patients, and position the UK as a leading place to develop, launch and use new medicines and technologies safely and effectively. By 2030, the MHRA aims to be even more patient-centred, support patients having faster access to safe, effective treatments, and have more data-connectivity and global influence.

The strategy defines the MHRA's mission to contribute to 'health and prosperity for all, through scientific excellence' and reaffirms its central purpose to protect patients, improve public health and enable faster access to innovation.

Minister for Health Innovation, James Frith 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.

MHRA Chief Executive, Lawrence Tallon 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.

MHRA Chair, Professor Anthony Harnden said:

Our 2030 Strategy sets out our vision for how we will harness extraordinary scientific and technological advances to catalyse innovation in the life sciences and accelerate access to safe and effective treatments for patients.

This is an ambition we can only achieve by working together, and I would like to thank patients, healthcare professionals, the life sciences industry and our international counterparts for their continued collaboration and shared commitment to protecting the public.

Richard Torbett, Chief Executive of the ABPI, said:

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. The agency has already made real progress on these issues, and this strategy builds on that progress with confidence.

We look forward to working with the MHRA to turn ambition into delivery, so that patients benefit from new medicines sooner and the UK stays at the forefront of a fiercely competitive global life sciences sector.

Dr Matt Westmore, Chief Executive at the Health Research Authority, said:

The MHRA's new strategy outlines an ambitious plan to reshape regulation for a new era, and the HRA will play a key role in helping to deliver that ambition.

In the past 12 months alone the MHRA and HRA have delivered the largest overhaul of clinical trials legislation for a generation. The updated regulations further protect trial participants, strengthen patient safety and will help accelerate approvals by reducing unnecessary burdens on researchers.

Alongside reforms to clinical trials legislation the HRA, MHRA and IRAS Partners have been working to transform the digital end-to-end journey for research in the UK. This transformation will ensure that HRA and MHRA processes are aligned and improve the user journey from application right through to patient enrolment.

Lead real-world evidence generation and regulation:

• Enhance access to real-world data from hospitals and genomics.
• Recruit specialised skills and expertise and use AI to analyse real world data and identify potential safety issues earlier.
• Work with the Health Data Research Service to use real-time surveillance to identify safety signals sooner and collect data on investigational medicinal products.
• Improve the collection and use of medical device data and enable precise identification and traceability of devices throughout their lifecycle.
• Make Yellow Card reporting of adverse events with medicines and medical devices simpler and quicker for patients and healthcare professionals.

Deliver operational excellence:

• Introduce a new higher value service option for medicine and medical product developers to fast-track the scientific advice service from 90 days to 45 days.
• Cut by half the initial assessment target for qualifying Phase 1 clinical trials to 14 days.
• Make faster decisions on generic and biosimilar products so that patient access to these medicines and savings to the NHS can be made at the earliest opportunity.

Provide patient-centred regulation:

• Increase diversity in clinical studies and launch a Women's Health Plan this year to secure better health outcomes for women and to close health gaps between different ethnic groups.
• Strengthen patients' contributions to regulatory decisions and publish a refreshed Patient and Public Involvement and Engagement Plan this year.

Tackle the trade in illegal medicines:

• Substantially increase criminal enforcement capacity to investigate, disrupt and prosecute those involved in illegal medicines and medical devices activity.
• Work with social media platforms and online marketplaces to tackle misinformation and prevent harmful products from reaching the public.

Support innovation in life sciences:

• Enable a shift away from the use of animal models towards human-relevant new approach methodologies (NAMs), such as organoids.
• Reduce regulatory barriers for UK start-ups and smaller companies with a targeted voucher scheme.
• Develop a more flexible and risk-proportionate regulatory framework for rare disease therapies and better connect the UK's genomics capability with the NHS and MHRA.

Transform regulation with AI and pioneer MedTech methodologies

• Develop an AI-enabled Clinical Trial Protocol Checker to give sponsors regulatory certainty and support faster, higher-quality clinical trial applications.
• Publish an AI Medicines Development Action Plan in 2027 setting out how AI will be used to transform medicines development.
• Establish an MHRA Centre for AI and Digital Health to make clearer regulatory expectations for developers of digital and AI-driven medical devices and medicines.
• Create a modern, adaptive regulatory framework for AI as a medical device.

Increase efficiency through international collaboration:

• Expand reliance and recognition routes with trusted regulators, including collaboration with the US FDA and continued recognition of CE-marked devices.
• Engage with other national regulators through Regulatory Innovation Corridors to cut duplication and accelerate progress towards clinical studies.
• Chair the Access Consortium to support faster access to medicines in member countries (Australia, Canada, Singapore, Switzerland and the UK).
• Establish an annual regulatory science conference to bring together regulators, researchers and industry and reinforce the MHRA's global thought leadership.

Notes to editors

• The MHRA is an executive agency of the Department of Health and Social Care.
• For media enquiries, please contact the news centre on 020 3080 7651 or [email protected]