# Patient Involvement Strategy

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/36cbb4a5-7eb4-4e23-aaa9-c16587188adc
Type: Guidance
Published: September 30, 2021

> The Medicines and Healthcare products Regulatory Agency (MHRA) has established a new strategic framework centered on patient involvement and public partnership. Developed in response to the Independent Medicines and Medical Devices Safety Review, the strategy aims to rectify historical gaps in engagement by prioritizing the patient voice in regulatory decision-making. Although this specific document does not detail individual inspection dates or specific company violations, it sets the regulatory standard for how the MHRA will interact with the healthcare sector. The strategy underwent rigorous validation, including approval by the Agency Board and a final public consultation to ensure it met patient expectations. Key required actions include the continuous integration of public feedback into agency processes and the formation of collaborative partnerships with health sector organizations. This initiative represents a fundamental shift in the UK regulatory landscape, moving toward a more transparent and responsive system. By committing to an ongoing dialogue, the MHRA aims to enhance the safety and efficacy of medical products through collective oversight. The successful execution of this plan is viewed as an ambitious journey that requires the MHRA to act as a partner to the public rather than a detached authority, ensuring that patient safety remains the primary focus of all future regulatory activities and health interventions.

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## Content

In developing the strategy, we have started as we mean to continue. Our approach was informed at the very outset through consultation with patients on what was important to them. The Independent Medicines and Medical Devices Safety Review also provided us with clear direction on where we could improve our engagement with patients, and the resulting strategy was then approved by our Patient Safety and Engagement Committee and Agency Board. We wanted to be sure that the strategy resonated with patients too, conducting a final public consultation on the strategy to identify any areas that we needed to adapt, or that we had overlooked. This step allowed us to make some further additions to our approach and we will continue to listen to patients throughout as we deliver it. We recognise that these are the first steps on an ambitious journey, and that its successful delivery lies in the engagement and involvement of the public, patients and other health sector organisations as partners, with us on the journey.

## Attachments

- [Patient Involvement Strategy 2021-25](/government/publications/patient-involvement-strategy/patient-involvement-strategy-2021-25)
- [Patient Involvement Strategy 2021-25](https://assets.publishing.service.gov.uk/media/6405c608e90e0740dafbbc1d/Patient_involvement_strategy.pdf)