The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new plan where patients and the public would have a greater role in shaping medicines and medical device regulation.
The Patient and Public Involvement and Engagement Plan 2026–2030 (PPIE) 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.
Now, 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 announcement supports the MHRA’s newly-published Strategy to 2030 and builds on its Patient Involvement Strategy 2021–2025.
As part of the new plan, the MHRA will strengthen feedback, monitoring and reporting so people can see how their contributions have influenced the MHRA’s work; expand membership of its Patient and Public Community to better reflect the diversity of the UK population; use deliberative engagement to ensure patient and public perspectives shape how the benefits and risks of medicines are assessed; and involve patients and the public in work to make medicines information clearer and more accessible.
The Agency will also 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."
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."
