MHRA 2030 Strategy targets faster trials, AI regulation and real-world evidence

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its MHRA 2030 Strategy, which sets out how the UK regulator plans to adapt to advances in artificial intelligence (AI), personalised medicines and other emerging technologies. The strategy, published on 14 October 2026, applies to patients across all four nations of the UK.

The MHRA, an executive agency of the Department of Health and Social Care, said the commitments would help it keep pace with rapid advances in science, technology and personalised healthcare. By 2030, the agency said it aims to be more patient-centred, support faster access to safe and effective treatments, and have greater data connectivity and global influence. The strategy defines its mission as contributing to “health and prosperity for all, through scientific excellence”.

Shorter timelines for scientific advice and clinical trials

Among its operational targets, the MHRA will introduce a new higher value service option allowing medicine and medical product developers to fast-track scientific advice from 90 days to 45 days. It will also halve the initial assessment target for qualifying Phase 1 clinical trials to 14 days.

The agency said it will make faster decisions on generic and biosimilar products, so that patients can gain access to these medicines, and the NHS can make savings, at the earliest opportunity.

Dr Matt Westmore, Chief Executive at the Health Research Authority (HRA), said: “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.”

AI and digital health in the MHRA 2030 Strategy

The MHRA plans to establish a Centre for AI and Digital Health to set clearer regulatory expectations for developers of digital and AI-driven medical devices and medicines. It will also create a modern, adaptive regulatory framework for AI as a medical device and publish an AI Medicines Development Action Plan in 2027.

An AI-enabled Clinical Trial Protocol Checker is intended to give sponsors regulatory certainty and support faster, higher-quality clinical trial applications.

MHRA Chief Executive Lawrence Tallon said: “These ground-breaking developments challenge traditional regulatory models and require innovative approaches to evidence generation, clinical research design, manufacturing oversight and safety and surveillance.”

Real-world evidence and safety monitoring

The strategy commits the agency to enhancing access to real-world data from hospitals and genomics, recruiting specialised expertise and using AI to identify potential safety issues earlier. It will work with the Health Data Research Service on real-time surveillance to detect safety signals sooner and to collect data on investigational medicinal products.

The MHRA also intends to improve the collection and use of medical device data, enable traceability of devices throughout their lifecycle and make Yellow Card reporting of adverse events simpler and quicker.

Patients, illegal medicines and support for innovators

The agency will launch a Women’s Health Plan this year, aiming to increase diversity in clinical studies and close health gaps between different ethnic groups, and will publish a refreshed Patient and Public Involvement and Engagement Plan. Life Sciences Global News has previously reported on the MHRA consultation on letting UK schools stock spare adrenaline nasal sprays.

The MHRA said it will substantially increase criminal enforcement capacity against illegal medicines and medical devices, and work with social media platforms and online marketplaces to tackle misinformation. Minister for Health Innovation James Frith said the strategy would strengthen the regulator’s “ability to crack down on illegal medicines to keep the public safe”.

For developers, the strategy includes a targeted voucher scheme for UK start-ups and smaller companies, support for a shift from animal models towards new approach methodologies such as organoids, and a more risk-proportionate framework for rare disease therapies.

International collaboration and industry response

The MHRA 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 devices. It will chair the Access Consortium of Australia, Canada, Singapore, Switzerland and the UK, and establish an annual regulatory science conference.

Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry (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.” He added that the strategy included “firm service guarantees, closer working with NICE and patients at the centre of every decision”, referring to the National Institute for Health and Care Excellence.

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