MHRA Patient and Public Involvement and Engagement Plan 2026-2030 (5 November 2026)

Summary

This plan sets out the Medicines and Healthcare products Regulatory Agency (MHRA) approach to patient and public involvement and engagement from 2026 to 2030. It explains how they will involve patients, carers and the wider public in regulatory decisions. This includes medicines safety, medical devices and emerging technologies. It outlines their principles for inclusive engagement, transparency and collaboration, and how they will seek to ensure a broader range of voices and experiences inform their work.

Content

Principles

The MHRA describe the following principles that will guide their approach to patient, public involvement and engagement:

Creating inclusive opportunities

• We will create opportunities to ensure regulatory decisions are informed by the experiences of people who may otherwise be underserved or disproportionately affected.

• We will use a range of involvement and engagement methods to reach diverse audiences, including communities affected by rare conditions and health inequalities.

• We will use what we hear to help address gaps where research has not adequately reflected the diversity of people who use medicines and devices, supporting fairer and more representative regulatory decisions.

Transparency

• We will be clear about the purpose, scope, and limits of involvement, and communicate how contributions influence regulatory thinking, guidance, policy, and decisions.

Working together

• We will collaborate with partners to involve people early, ensuring lived experience informs decisions alongside clinical and scientific evidence.

• We will adapt and improve our approach based on feedback and learning

Focus areas

The MHRA also describes the following areas of focus for the new plan:

Addressing evidence gaps and supporting proactive regulation

• We will use patient and public involvement to identify and help address evidence gaps where lived experience has historically been under weighted.

• This includes involving patients early in areas of unmet need, such as women’s health, and where regulatory frameworks may need to evolve.

Patient centred regulation

• We will involve patients and the public in shaping and testing approaches to patient centred, proportionate regulation, including how benefits and risks are understood and weighed. This will ensure regulatory decisions better reflect what matters most to people affected.

Patient safety

• Patient and public involvement will remain central to our safety and surveillance work.

• We will continue to test medicines in our laboratories to ensure they are always of the highest possible quality for patients.

• We will also continue to develop the key testing materials needed to ensure accurate measurements when clinicians assess patients’ health.

Supporting science and innovation

• We will involve patients and the public early in the development of new regulatory pathways and areas of innovation, particularly where science, technology or data raise complex questions.