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MHRA publishes 2026–2030 plan to widen patient involvement in medicines and device regulation

🇬🇧 MHRA · Thu 05 Nov 2026

The UK regulator says it will involve patients earlier, reach more diverse communities and show how their input shapes decisions, with NICE collaboration to cut duplicated evidence.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its Patient and Public Involvement and Engagement Plan 2026–2030, setting out how it intends to give patients and the public a bigger part in regulation. The plan is a key element of the agency's Strategy 2030 and succeeds its Patient Involvement Strategy 2021–2025.

The MHRA says patients' lived experience will help inform decisions on medicine benefit-risk assessment, safety reviews, regulatory policy and patient information. It will also feed into approaches for rare diseases, medical devices, future regulatory pathways, artificial intelligence and other emerging technologies. The plan responds to feedback asking for more inclusive participation and for clearer information on how involvement affects decisions.

Commitments include stronger feedback, monitoring and reporting so contributors can see their influence, and wider membership of the Patient and Public Community to better reflect the UK population. That community was set up in October 2024 and brings together patients, patient organisations and charities. The agency will also use deliberative engagement in how the benefits and risks of medicines are assessed, and involve the public in making medicines information clearer and more accessible.

The MHRA also plans to work with the National Institute for Health and Care Excellence (NICE) to reduce duplication in the patient involvement evidence used for regulatory and health technology assessments. As an example of existing work, it cited a 23-member patient advisory group that has contributed to its Rare Disease Consortium, helping to identify priorities, inform draft guidance and drive medicines repurposing.

The People and Public Engagement Committee, chaired by MHRA Non-Executive Director Mercy Jeyasingham MBE, will oversee progress. The announcement was welcomed by the Patient Safety Commissioners for England and Scotland. The published material does not set out binding requirements or deadlines for industry.

What it means for your team

  • Regulatory teams should expect patient input to play a more structured part in benefit-risk assessment, safety reviews and policy development at the MHRA.
  • Companies with UK submissions may find patient involvement evidence better aligned between regulatory and HTA processes if the planned MHRA–NICE work reduces duplication; details are yet to come.
  • Teams working on patient information, rare diseases, devices or AI-enabled products may see more public involvement in related guidance and materials.
  • The announcement imposes no new obligations on industry, but sponsors may wish to review their own patient engagement and feedback practices.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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