THE UK’S medicines regulator has put patient safety at the forefront of its strategy over the next four years and will focus on getting new treatments to patients sooner while bolstering AI regulation.
The Medicines and Healthcare products Regulatory Agency (MHRA) will this morning set out its strategy for 2030 outlining its priorities over the coming years, including an eight-pronged approach to achieving ‘better outcomes’.
Responsible for the regulation of all medicines and medical devices across the UK , the MHRA will highlight artificial intelligence, precision medicine and innovation, as well as international collaboration, as key areas of focus in this time of ‘extraordinary change’.
The report will place patient-centred regulation at the top of its list of commitments, promising to lay out a clear and transparent benefit and risk framework by 2027 to describe its regulatory decision-making process.
The agency plans to involve patients more closely in regulatory decisions and address gaps in evidence for under-represented demographics. It will also pledge to modernise product information, making it available in digital formats, and support easier access to medicines where evidence justifies it.
The strategy acknowledges that treatment choices will differ between patients, depending on their health, circumstances and preferences, as well as the way they weigh up risks and benefits. Clearer information will aim to help patients and clinicians make these decisions together.
The report, which identifies AI as a “defining medical technology”, sets out the MHRA’s aims to deliver a global standard for safe and agile regulation of AI and MedTech in healthcare.
To do this, the agency plans to establish an MHRA Centre for AI and Digital Health that will bring together specialist leadership and expertise to support the regulation of digital and AI-driven products, including medical devices and medicines.
Its wider MedTech programme includes reforming pre-market regulations and strengthening post-market surveillance for medical devices, speeding up patient access to these products whilst monitoring their safety throughout their lifecycle.
Alongside these reforms, the MHRA will pledge to make its services faster and more predictable, with initial assessments of first-in-human trials within 14 days and first assessments of licensing applications within 90 days.
They will also announce that safety monitoring will move towards more continuous oversight, using linked health data and AI to identify emerging risks earlier.
The agency also plans to strengthen medical device traceability and increase enforcement against counterfeit and illegally supplied products.
From 2027, the MHRA will begin introducing a more conversational interface for its Yellow Card reporting scheme, making it easier for patients and healthcare professionals to report suspected side effects and device concerns. It will also explore integrating the service into the NHS App and hospital electronic health record systems.
To help new treatments reach patients sooner, the MHRA will continue working with the National Institute for Health and Care Excellence (NICE) to bring licensing and value assessments closer together.
The report says this aligned approach could allow patients to access some new medicines as much as three to six months earlier than under previous sequential pathways.
To allow developers and regulators to test new technologies and approaches in controlled environments, the strategy also outlines plans for regulatory sandboxes.
The initial areas of focus for these testing environments will include AI as a medical device and the use of AI in pre-clinical testing, with an AI Medicines Development Action Plan due in 2027.
Smaller companies will also receive additional support to navigate regulatory requirements, including a targeted voucher scheme to help UK start-ups access premium services at lower cost.
They will pledge scientific investment that will focus on strengthening laboratory capacity, biological standards and the use of real-world evidence, alongside computational modelling, digital twins and synthetic data.
Scientifically valid alternatives to animal testing, including organoids and organ-on-a-chip technologies, will also be backed by the agency, along with improving preparedness for pandemics and antimicrobial resistance
International collaboration will remain central to the strategy, with closer working relationships planned with the US Food and Drug Administration, European regulators and partners in India, China, the Middle East and North Africa.
These partnerships will aim to reduce duplication in regulatory assessments, share safety information and strengthen medicine supply chains.
The MHRA’s ambition is for high-quality regulatory submissions to be prepared once and used across multiple trusted jurisdictions, helping companies bring products to patients more efficiently whilst maintaining robust standards.
Delivering these commitments, the report will stipulate, depends on recruiting and retaining specialist staff, strengthening training and leadership, and improving workforce planning.
To do this, the agency plans to expand its Digital Hub in Leeds and broaden secondment activity across Scotland, Wales and Northern Ireland.
Overall, the strategy concludes that collaboration between patients, healthcare professionals, researchers, industry and international partners, will be essential to protecting public health and translating innovation into better outcomes.
Some proposed regulatory reforms, including new powers for the MHRA to assess medical devices directly, remain subject to parliamentary approval.
Read the full report here at 10am.
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