MHRA 2030 Strategy sets out plans for real-world evidence, AI, and regulatory reform

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its five-year strategy, outlining priorities to modernize UK regulation, strengthen safety surveillance and support access to medicines and medical technologies.

The Baseline

• The MHRA has published its 2030 Strategy, outlining plans to modernize UK regulation of medicines and medical technologies.
• Priorities include expanding real-world evidence use, strengthening safety surveillance, and improving regulatory efficiency through AI-enabled tools.
• The strategy also aims to support earlier patient access, greater patient involvement, and more flexible approaches to evidence generation.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2030 Strategy, outlining plans to modernize UK regulation in response to developments in AI, personalized medicines, and advanced therapies. The strategy focuses on expanding the use of real-world evidence (RWE), strengthening safety surveillance, and improving regulatory efficiency, alongside greater patient involvement.

Titled ‘Health and Prosperity for All Through Scientific Excellence’, the strategy sets out changes to evidence generation, clinical research, and regulatory assessment. Lawrence Tallon, Chief Executive, MHRA, explained:

“These ground-breaking developments challenge traditional regulatory models and require innovative approaches to evidence generation, clinical research design, manufacturing oversight and safety and surveillance.”

A central priority is expanding the use of real-world data (RWD) and RWE across the regulatory lifecycle. The MHRA plans to improve access to linked primary care, hospital and genomic data, building on its Clinical Practice Research Datalink (CPRD) and collaborating with the Health Data Research Service (HDRS). The expanded use of linked health data is intended to support pharmacogenomics, clinical research, and safety monitoring, including for treatments used in specialist settings.

The strategy describes a move towards continuous, data-driven safety surveillance of medicines and medical devices. Specialist recruitment, advanced statistical methods and AI-enabled tools will strengthen the agency’s capacity to analyze data and identify potential safety signals earlier.

In an accompanying opinion article, Professor Anthony Harnden, Chair, MHRA, highlighted the role of RWD in assessing benefits and risks across the diversity of patients and settings not fully represented in clinical trials.

“By making clinical reporting easier and using the latest technologies to analyze RWD, we will build a system of continuous learning that keeps pace with scientific innovation and improves health outcomes for all.”

Harnden also emphasized the role of clinicians in identifying adverse reactions, device failures, and variations in treatment outcomes during routine practice. From 2027, the MHRA plans to introduce a more conversational Yellow Card reporting interface and explore integration with the NHS App and hospital electronic health record systems to support safety reporting.

Regulatory efficiency is another priority, with a 14-day initial assessment target for qualifying Phase 1 clinical trials and an optional expedited scientific advice service with a 45-day turnaround. An AI-enabled Clinical Trial Protocol Checker is also being developed to help sponsors identify potential deficiencies before submitting applications.

Closer coordination with the National Institute for Health and Care Excellence (NICE) is intended to align regulatory approval and health technology assessment (HTA). According to the MHRA, closer alignment could reduce the interval between regulatory approval and NICE guidance by three to six months for relevant medicines, supporting earlier access through parallel decision-making.

The MHRA also plans to establish a Centre for AI and Digital Health and publish an AI Medicines Development Action Plan in 2027. Further commitments include guidance on digital twins, exploration of hybrid trials incorporating synthetic data, regulatory sandboxes, and new approach methodologies intended to reduce reliance on animal testing. For AI-enabled medical devices the agency proposes more adaptive oversight, including expanded use of Predetermined Change Control Plans and exploration of Master Files for foundation models.

For rare disease therapies, the MHRA intends to develop a more flexible, risk-proportionate regulatory framework that accounts for the challenges of generating evidence in small patient populations.

Patient involvement and transparency are additional priorities, with plans to improve diversity in clinical research, introduce a Women’s Health Plan, and publish a refreshed Patient and Public Involvement and Engagement Plan in 2026. The agency also intends to publish a methodological framework for benefit-risk assessment in 2027, initially covering medicines before extending to medical devices.

Internationally, the MHRA plans to expand recognition and reliance arrangements with trusted regulators, including the US FDA and European counterparts, to reduce duplication in assessments, strengthen supply chains and support access to medicines and medical technologies. The strategy also includes commitments to strengthen enforcement against illegal medicines and medical devices.