New plan puts patients at the heart of medicines and medical device regulations

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new plan to strengthen patient and public involvement in regulating medicines and medical devices across the UK

The Patient and Public Involvement and Engagement Plan 2026–2030 sets out how the regulator will give patients and members of the public more opportunities to influence decisions, improve patient safety, and help shape future innovation.

Published on 5 November 2026, the plan builds on the agency’s previous Patient Involvement Strategy, which ran from 2021 to 2025, and responds to calls for more inclusive engagement and greater transparency about how public feedback influences regulatory decisions.

Giving patients a voice

Under the new plan, the MHRA aims to involve patients earlier in the regulatory process and ensure a wider range of communities are represented.

Patients’ experiences will help inform important decisions, including assessments of the benefits and risks of medicines, medicine safety reviews, regulatory policies and the development of clearer patient information.

Their input will also contribute to emerging areas of regulation, including rare diseases, medical devices, artificial intelligence (AI) and new approaches to developing and approving treatments.

The agency hopes that involving people with different backgrounds and experiences will help ensure regulatory decisions reflect the needs and priorities of those affected.

Improving engagement and transparency

The Patient and Public Involvement and Engagement Plan outlines several practical steps to strengthen public involvement.

These include expanding the MHRA’s Patient and Public Community to represent the diversity of the UK population better and improving how feedback is monitored and reported. This will help participants understand how their contributions have influenced the agency’s work.

The MHRA will also introduce more deliberative engagement, allowing patients and members of the public to contribute to discussions about how the benefits and risks of medicines should be assessed.

Another priority is making medicines information clearer and more accessible, alongside working with the National Institute for Health and Care Excellence (NICE) to reduce duplication in the evidence patients are asked to provide during regulatory and health technology assessments.

Building on existing patient involvement

The MHRA has already seen the benefits of patient participation through its work on rare diseases.

A dedicated advisory group of 23 patient representatives has supported the agency’s Rare Disease Consortium, helping identify priorities, contribute to draft guidance and advance work on medicines repurposing.

The new Patient and Public Involvement and Engagement Plan aims to build on this approach and make meaningful patient involvement a more consistent part of the regulator’s work.

Progress will be overseen by the MHRA’s People and Public Engagement Committee, which will monitor the delivery of commitments and ensure patient contributions lead to practical improvements.