PharmacovigilanceOfficial

MHRA publishes 2026-2030 plan to embed patient and public involvement in regulation

🇬🇧 MHRA · Thu 05 Nov 2026

The UK regulator's new corporate plan sets out how patients, carers and the public will be involved in its decisions, building on the 2021-2025 strategy.

The Medicines and Healthcare products Regulatory Agency (MHRA) published its Patient and Public Involvement and Engagement Plan 2026-2030 on 5 November 2026. The agency describes it as its approach to placing meaningful involvement and engagement at the heart of its work.

The plan builds on the MHRA's Patient Involvement Strategy 2021-2025. It explains how patients, carers and the wider public will be brought into regulatory decisions, with medicines safety, medical devices and emerging technologies named as areas of focus.

The document sets out principles for inclusive engagement, transparency and collaboration, and says the agency wants a broader range of voices and experiences to inform its work. Its priorities include strengthening partnerships, improving opportunities for involvement, and demonstrating how patient and public contributions influence regulatory decisions and outcomes. The MHRA says it also lists planned activities over the next three years.

This is a strategic corporate document. It is non-binding and introduces no new regulatory requirements for industry. It does, however, indicate how patient input could shape future MHRA activity, including safety communications and policy consultations. The plan is available in HTML and as a 24-page PDF, with a 22-page easy-read version.

What it means for your team

  • No new obligations arise for marketing authorisation holders or device manufacturers; the plan is a statement of the MHRA's own approach.
  • Policy and regulatory affairs teams may wish to read the plan to anticipate how patient perspectives could feature in future MHRA consultations.
  • Pharmacovigilance and communications teams should note that patient involvement is named as relevant to medicines safety, which may influence how safety messages are developed.
  • The commitment to show how contributions influence decisions suggests the MHRA expects to report on the effect of involvement, though the source gives no specific metrics.

Official source: MHRA ↗

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

More Pharmacovigilance All →