New plan will broaden participation and make clearer how patient experience informs regulatory decisions, safety and innovation
Patients and the public will have a greater role in shaping medicines and medical device regulation under a new plan published today by the Medicines and Healthcare products Regulatory Agency (MHRA).
The Patient and Public Involvement and Engagement Plan 2026–2030 (PPIE) , a key tenet of the MHRA’s Strategy 2030, sets out how the agency will involve and engage people earlier, hear from a wider range of patient groups and communities and explain openly and clearly how patients’ experiences shape its work.
Patients’ lived experience will help inform decisions at the MHRA, including the assessment of medicine benefits and risks, safety reviews, regulatory policy, patient information and the development of regulatory approaches for rare diseases, medical devices, future regulatory pathways, artificial intelligence (AI) and other emerging technologies.
The plan supports the MHRA’s newly-published Strategy to 2030, builds on its Patient Involvement Strategy 2021–2025 and responds to feedback calling for more inclusive participation and information on how patient involvement shapes regulatory decisions.