MHRA sets out approach to strengthen patient and public involvement and engagement in medicines and medical device regulation
New plan will broaden participation and make clearer how patient experience informs regulatory decisions, safety and innovation
Patients and the public will have a greater role in shaping medicines and medical device regulation under a new plan published today by the Medicines and Healthcare products Regulatory Agency (MHRA).
The Patient and Public Involvement and Engagement Plan 2026–2030 (PPIE), a key tenet of the MHRA’s Strategy 2030, sets out how the agency will involve and engage people earlier, hear from a wider range of patient groups and communities and explain openly and clearly how patients’ experiences shape its work.
Patients’ lived experience will help inform decisions at the MHRA, including the assessment of medicine benefits and risks, safety reviews, regulatory policy, patient information and the development of regulatory approaches for rare diseases, medical devices, future regulatory pathways, artificial intelligence (AI) and other emerging technologies.
The plan supports the MHRA’s newly-published Strategy to 2030, builds on its Patient Involvement Strategy 2021–2025 and responds to feedback calling for more inclusive participation and information on how patient involvement shapes regulatory decisions.
Under the plan, the MHRA will:
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Strengthen feedback, monitoring and reporting so people can see how their contributions have influenced the MHRA’s work.
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Expand membership of its Patient and Public Community to better reflect the diversity of the UK population.
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Use deliberative engagement to ensure patient and public perspectives shape how the benefits and risks of medicines are assessed.
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Involve patients and the public in work to make medicines information clearer and more accessible.
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Work with the National Institute for Health and Care Excellence (NICE) to reduce duplication in patient involvement evidence used for regulatory and health technology assessments.
Professor Anthony Harnden, Chair of the MHRA, said:
Our Patient and Public Involvement and Engagement Plan is a vital evolution in the way we connect and listen to patients and the public at a time when the dynamic landscape of medicines and medical devices regulation is changing rapidly.
Bringing those who matter most into the heart of our regulatory and decision-making processes, patients and the public can tell us how treatments affect their everyday lives, what benefits they value most and where information needs to be clearer. That insight helps us ask better questions and make better-informed regulatory decisions.
Through this plan, we will involve people earlier, hear from a broader range of communities and patient demographics and explain how their contributions have influenced our work.
Patient involvement has already helped shape the MHRA’s work on rare diseases. A dedicated advisory group of 23 patient representatives has contributed to the MHRA’s Rare Disease Consortium, helping identify priorities, informing draft guidance and spearheading medicines repurposing.
Mercy Jeyasingham MBE, MHRA Non-Executive Director and Chair of the People and Public Engagement Committee, said:
This plan combines ambition with practical and achievable commitments to strengthen how we involve patients and the public in our work.
A consistent approach across the agency will help ensure that people’s experiences inform our work and that those contributing understand how their input has been used. The People and Public Engagement Committee will oversee progress, helping turn these commitments into meaningful and lasting improvements.
Professor Henrietta Hughes OBE, Patient Safety Commissioner for England, said:
I welcome this plan and its commitment to putting patients’ voices at the heart of regulation. Patient experience should be central to regulatory decisions.
Listening to a diverse range of voices, particularly those that are under-represented, provides early insight into risks and inequalities. This insight is what strengthens patient safety and helps ensure regulation reflects what matters most to the people it serves.
Karen Titchener, Patient Safety Commissioner for Scotland, said:
People across Scotland have repeatedly told us how important it is that their experiences of healthcare are listened to and acted upon. Patients and families are experts in their own experiences, and their insights can help shape safer medicines, medical devices and healthcare systems.
I welcome the MHRA’s commitment to broadening participation and involving patients earlier in decision-making. Meaningful engagement helps ensure that regulatory decisions are informed not only by clinical evidence, but also by the realities of people’s lives.
Notes to editors
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The MHRA regulates medicines, medical devices and blood components for transfusion in the UK.
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Read the Patient and Public Involvement and Engagement Plan 2026–2030
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The MHRA’s People and Public Engagement Committee will review progress in delivering the plan.
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The Patient and Public Community was established in October 2024. It brings together patients, patient organisations and charities to inform the MHRA’s work and policy development.
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For media enquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.
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