The medicines regulator’s new 2030 Strategy promises faster scientific advice, a dedicated MHRA funded Centre for AI and Digital Health, and greater use of real-world evidence. As the UK seeks to turn scientific advances into better care, the challenge will be connecting regulatory reform with NHS adoption – an issue UKHLSI’s AI Working Group will explore at its next meeting on 16 November. (Photo: MHRA CEO Lawrence Tallon addresses the UK Healthcare and Life Sciences Innovation and UKAI AI in Healthcare and Life Sciences Showcase in Parliament)
Published on 14 October, the 2030 Strategy sets out how the agency intends to support faster access to safe and effective treatments while strengthening patient involvement, improving safety monitoring and tackling illegal medicines.
Its ambitions extend beyond approving individual products. The strategy envisages a regulator that uses AI in its own work, draws more effectively on hospital and genomic data, and collaborates internationally to reduce duplication.
For patients, the promise is earlier access to innovations that can prevent, diagnose and treat disease. For developers, it is a clearer and more predictable route through regulation. Whether those benefits reach frontline care will depend on how effectively the strategy connects with the wider health system.
AI is changing healthcare – and the regulator intends to change with it
Among the most significant commitments is the establishment of an MHRA Centre for AI and Digital Health, intended to clarify regulatory expectations for developers of digital and AI-driven medical devices and medicines.
The agency also plans to create a modern, adaptive framework for AI as a medical device and publish an AI Medicines Development Action Plan in 2027.
An AI-enabled Clinical Trial Protocol Checker will support sponsors in preparing higher-quality applications, while the regulator intends to recruit specialist expertise and use AI to analyse real-world data and identify potential safety concerns earlier.
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.”
The distinction between regulating AI and using AI to regulate matters. Developers need clarity about the evidence their products must generate; the MHRA will also need assurance that its own AI tools produce reliable, explainable results.
An adaptive framework will therefore need to combine flexibility with clear accountability, particularly where a product’s performance changes after deployment.
Faster regulatory decisions could help patients – if the wider pathway keeps pace
The strategy includes concrete proposals to improve regulatory services.
A new higher-value service option will shorten the scientific advice timetable from 90 days to 45 days, while the initial assessment target for qualifying Phase 1 clinical trials will be halved to 14 days.
The MHRA also intends to make faster decisions on generic and biosimilar products, supporting earlier patient access and opportunities for NHS savings.
For businesses, predictable timelines can be as valuable as shorter ones, helping developers plan studies, investment and market entry.
However, regulatory approval is one stage in the journey to patient access. Evidence requirements, assessment, commissioning, procurement, workforce readiness and implementation must connect. Otherwise, time saved during regulation risks being lost later in the pathway.
The proposed targeted voucher scheme to reduce regulatory barriers for start-ups and smaller companies could help broaden access to support. Its practical value will depend on eligibility, availability and how well it addresses the costs smaller developers face.
Better safety monitoring will depend on better-connected data
The MHRA plans to enhance access to real-world data from hospitals and genomics, working with the Health Data Research Service to identify safety signals sooner and collect information on investigational medicinal products.
For medical devices, the strategy promises better data collection and more precise identification and traceability throughout their lifecycle. Yellow Card reporting will also become simpler and quicker for patients and healthcare professionals.
These commitments recognise that evidence generation continues after a product enters use. Real-world data can help reveal how treatments perform across different populations and clinical settings.
For AI, this is particularly relevant: performance may vary between organisations, patient groups and workflows. Effective surveillance will require consistent information, clear reporting responsibilities and the ability to act when problems emerge.
Data connectivity should therefore be judged by whether it supports timely clinical and regulatory decisions, alongside its technical reach.
Co-Chair of the UKAI Healthcare and Life Sciences Working Group, and President of Genomics, Dave Thornton welcomed the strategy:
“As a science-led pioneer in healthcare and life sciences, we welcome the MHRA’s commitment to supporting scientific excellence and innovation. The 2030 Strategy will help people access transformative scientific and technological innovation faster, ultimately leading to better health outcomes.”
Co-Chair of the UKAI Healthcare and Life Sciences Working Group, and VP, Head of R&D Digital and AI at Lundbeck, Adama Ibrahim said:
“The MHRA 2030 Strategy creates a real opportunity to redesign the regulated life-sciences pathway end to end. With commitments including an AI-enabled Clinical Trial Protocol Checker, a 2027 AI Medicines Development Action Plan, a Centre for AI and Digital Health, faster Phase I assessment and greater use of real-world data, the opportunity is bigger than automating individual regulatory steps.
“Pharma, regulators, NHS partners and technology companies should view this strategy as opening up opportunities for collaboration pre-competitively to accelerate reinventing end-to-end workflows, evidence and decisions across regulated areas of the value chain.”
Patients must help shape innovation – and share in its benefits
The strategy commits the MHRA to increasing diversity in clinical studies, strengthening patients’ contributions to regulatory decisions and publishing a refreshed Patient and Public Involvement and Engagement Plan this year.
A Women’s Health Plan is also due this year, alongside commitments to improve outcomes for women and close health gaps between ethnic groups.
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.”
Patient involvement will be most meaningful where it influences the questions developers ask, the outcomes they measure and the judgements made about benefits and risks.
For AI developers, representative evidence should also be treated as central to product quality. Strong overall performance can conceal important differences between patient groups.
The strategy additionally promises substantially greater criminal enforcement capacity and work with social media platforms and online marketplaces to tackle misinformation and prevent harmful products reaching the public.
Chair of Curia’s Health, Care, and Life Sciences Research Group Rt Hon Andrew Stephenson welcomed the publication of the MHRA strategy after he recently hosted CEO, Lawrence Tallon in Parliament:
“I welcome the MHRA’s 2030 Strategy and its ambition to help patients benefit sooner from advances in AI, personalised medicines and diagnostics, while maintaining rigorous safety standards.
“The proposed Centre for AI and Digital Health offers an important opportunity to give innovators greater clarity and strengthen confidence in these technologies. Success will depend on connecting regulatory progress with NHS commissioning, procurement and workforce readiness, so that promising innovations reach patients and improve everyday care.
“Through Curia’s work with UKHLSI, we look forward to bringing industry, clinicians and policymakers together to support that ambition”.
A joined-up research system could strengthen the UK’s offer to innovators
The MHRA’s plans sit alongside work to reform clinical trials and improve the digital journey for researchers.
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.”
Other commitments include supporting human-relevant new approach methodologies, such as organoids, and developing more flexible, risk-proportionate regulation for rare disease therapies.
Internationally, the MHRA intends to expand reliance and recognition routes with trusted regulators, including collaboration with the US Food and Drug Administration and continued recognition of CE-marked devices.
Regulatory Innovation Corridors, leadership of the Access Consortium and an annual regulatory science conference are also intended to strengthen collaboration and reduce duplication.
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.”
The next test is turning regulatory ambition into everyday care
The strategy offers a substantial agenda for modernising the MHRA. Its combination of clearer services, stronger surveillance, patient involvement and dedicated AI capability addresses several practical challenges facing health innovators.
Delivery will require the specialist workforce, data infrastructure and operational capacity to sustain those commitments. Progress should be assessed through measurable improvements in regulatory performance, patient safety and access.
A further question sits beyond the regulator’s direct control: how will the NHS prepare to use the innovations that emerge?
A well-regulated AI product still needs a clear clinical purpose, evidence relevant to its intended setting, workable integration and staff able to use it confidently. Developers also need to understand how regulatory evidence connects with the evidence required by NHS decision-makers.
The opportunity is to build a more coherent route from development to deployment, with responsibilities understood at each stage.
Chief Executive of health innovators trade association, UK Healthcare and Life Sciences Innovation (UKHLSI), Jo Bekis said:
“The MHRA’s new 2030 Strategy is a positive step toward ensuring regulation keeps pace with advances in AI, personalised medicine and digital health. By focusing on faster access to innovation, and stronger patient involvement, it has the potential to improve outcomes for patients while strengthening the UK’s position as a leader in life sciences.”
Join UKHLSI on 16 November to help shape the AI adoption debate
UK Healthcare and Life Sciences Innovation’s AI Working Group next meets on 16 November, providing an opportunity for members to consider the implications of the MHRA’s strategy and the practical conditions needed for responsible AI adoption.
The proposed Centre for AI and Digital Health, adaptive regulation and greater use of real-world evidence create timely questions for developers, healthcare leaders and policy stakeholders: what guidance will innovators need, how should performance be monitored, and how can regulatory progress translate into improvements for patients?
UKHLSI is inviting organisations interested in contributing to this discussion to register their interest in the AI Working Group and find out more about getting involved ahead of the 16 November meeting.