Opportunities for patients and the public to be involved in the work of the MHRA
How we engage and involve patients and the public in our regulatory decision-making.
Agency’s commitment to patient, public involvement and engagement
The MHRA’s commitment to patient, public involvement and engagement is included in the agency’s Corporate Plan 2023-26.
We are a signatory of the shared commitment to public involvement in research. Read more in our blog Reflections on the shared commitment to public involvement.
Our approach to patient, public involvement and engagement
Our first Patient Involvement Strategy published in October 2021 set out how we would engage and involve the public and patients at every step of the regulatory journey. Our approach was informed at the very outset through consultation with patients on what was important to them. The Independent Medicines and Medical Devices Safety Review also provided us with clear direction on where we could improve our engagement with patients, and the resulting strategy was then approved by our Patient Safety and Engagement Committee and Agency Board.
If you would like to read about some of our activities within the first year of the strategy, please see our One Year On report for more information.
What the Public and Patient Involvement and Engagement Team do
The Patient, Public Involvement and Engagement Team (PPIE) acts as a centre of expertise within the MHRA, advising and supporting MHRA teams to plan, design and deliver high‑quality patient and public involvement and engagement activities.
Some of the projects where the public and patient engagement has assisted us include:
Rare Diseases
The MHRA has set up a Rare Disease Consortium to work with a range of stakeholders including patient representatives that support the development of a patient- focused regulatory framework. The framework will address the unique challenges of rare diseases and support the timely access to innovative therapies.
In 2025 workshops and meetings took place with patients and patient representatives to gain their views on a range of fundamental issues for the development of the framework. Continued patient involvement for this work will be crucial as the patient and rare disease community have the lived experience and expertise to enable the creation of a framework that best meets their needs.
ILAP
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
In 2025, the PPSE team recruited a pool of 20 Lay Members (members of the public) to work with the ILAP team over the next 2 years. They bring the public, patient perspective and voice to the assessment and selection of ILAP applications.
To ensure that Lay Members were able to contribute effectively, they received a comprehensive induction that explained the ILAP process, their role within in it and how to assess applications from a non-scientific perspective. Lay Members are a key part of the ILAP process.
Lay Member feedback has provided the ILAP team with crucial insight in how to improve the assessment of applications for future rounds. This process of continual improvement will continue going forward.
National Commission into the Regulation of AI in Healthcare
The National Commission into the Regulation of AI in Healthcare is an expert, non‑statutory advisory body established by the MHRA to review existing regulations and provide recommendations for a future regulatory framework for artificial intelligence in healthcare.
The work of the Commission includes a comprehensive research and engagement programme. Key engagement activities have included:
- A call for evidence survey
- Three deliberative sessions held across the UK, with participants selected to reflect the demographics of each host region.
- Three focus groups with targeted seldom‑heard communities: - Young people - Unpaid carers - People with learning difficulties
Public and Patient Community
The Patient and Public Community (PPC), previously known as the Patient Group Consultative Forum, was established in October 2024 following a review of our strategy to strengthen how patients and the public are involved in MHRA’s work.
The PPC is a key MHRA tool for patient and public involvement. It enables the agency to engage meaningfully with patients and patient organisations to inform regulatory work and policy development, helping to shape our decision‑making.
Who can join the PPC?
The PPC is open to individuals with an interest in medicines and medical devices, as well as patient groups and organisations that can represent the views of their members. The Community helps bring the patient and public voice into MHRA policy development and regulatory and scientific work.
Members are expected to:
- Take part in PPC meetings and online engagement
- Use lived experience to inform wider perspectives
- Respect confidentiality
- Champion patient safety and meaningful involvement
As a PPC member, you will help to shape MHRA’s work by sharing your insights, supporting better involvement of patients and the public. You will bring your lived experience to support MHRA engagement. You will have the opportunity to give feedback on draft materials and take part in surveys that inform our work.
How to get involved
We are keen to build a diverse and inclusive Community, representing a wide range of conditions, experiences and perspectives.
There are two types of membership:
- Individual members (patients or carers)
- Voluntary and community sector organisations
If you would like to join, please complete the relevant Expression of Interest form and read our Working Together Agreement before applying.
Updates to this page
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Added – Agency’s commitment to patient, public involvement and engagement Added - What the Public and Patient Involvement and Engagement Team do Updated - Our approach to patient, public involvement and engagement Updated - Public and Patient Community Removed – Public sessions of the board
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Included 'ways to get involved' including the documents: -Working Together Agreement -Expression of interest form – Individual -Expression of interest form - Organisation
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Edited - Other examples of patients’ involvement in our regulatory processes.
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New 'Patient Involvement Strategy' is now available.
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First published.