英国药品和保健品管理局（MHRA）阐述加强患者与公众在药品和医疗器械监管中参与和互动的方针
正文 · 中文译文
新闻稿 MHRA（英国药品和保健产品监管局）阐述加强患者和公众在药品与医疗器械监管中的参与和互动的方式 新计划将扩大参与范围，并更清晰地说明患者体验如何为监管决策、安全与创新提供依据 来源： 药品和保健产品监管局 发布时间： 2026年11月5日 根据药品和保健产品监管局（MHRA）今日发布的新计划，患者和公众将在塑造药品与医疗器械监管方面发挥更大作用。 《2026—2030年患者与公众参与和互动计划》（PPIE）是MHRA《2030年战略》的核心要义之一，阐明了该机构将如何更早地让民众参与和互动、听取更广泛患者群体和社区的意见，并公开清晰地说明患者的经历如何塑造其工作。 患者的亲身经历将有助于为MHRA的决策提供依据，包括药品获益与风险评估、安全性审查、监管政策、患者信息，以及针对罕见病、医疗器械、未来监管路径、人工智能（AI）和其他新兴技术的监管方法的制定。 该计划支持MHRA新发布的《2030年战略》，建立在其《2021—2025年患者参与战略》基础之上，并回应了要求实现更具包容性的参与以及了解患者参与如何影响监管决策的反馈意见。 根据该计划，MHRA将： 加强反馈、监测和报告，让人们看到他们的贡献如何影响了MHRA的工作。 扩大其患者与公众社区的成员范围，以更好地反映英国人口的多样性。 采用审议式参与，确保患者和公众的观点影响药品获益与风险的评估方式。 让患者和公众参与工作，使药品信息更清晰、更易获取。 与英国国家卫生与临床优化研究所（NICE）合作，减少用于监管和卫生技术评估的患者参与证据的重复。 MHRA主席Anthony Harnden教授表示： 我们的患者与公众参与和互动计划是一次至关重要的演进，正值药品和医疗器械监管的动态格局快速变化之际，它关乎我们联系和倾听患者与公众的方式。 将最重要的人置于我们监管和决策过程的核心，患者和公众可以告诉我们治疗如何影响他们的日常生活、他们最看重哪些获益以及哪些信息需要更加清晰。这种洞见有助于我们提出更好的问题并做出更明智的监管决策。 通过这项计划，我们将更早地让人们参与，听取更广泛社区和患者人群的意见，并解释他们的贡献如何影响了我们的工作。 患者参与已经帮助塑造了MHRA在罕见病方面的工作。一个由23名患者代表组成的专门咨询小组为MHRA罕见病联盟做出了贡献，帮助确定优先事项、为指南草案提供信息，并带头推动药物重定位。 MHRA非执行董事兼人民与公众参与委员会主席Mercy Jeyasingham MBE表示： 该计划将雄心与切实可行的承诺相结合，以加强我们让患者和公众参与工作的方式。 在整个机构采取一致的方法将有助于确保人们的经历为我们的工作提供信息，并使贡献者了解他们的意见是如何被使用的。人民与公众参与委员会将监督进展，帮助将这些承诺转化为有意义且持久的改进。 英格兰患者安全专员Henrietta Hughes OBE教授表示： 我欢迎该计划及其将患者声音置于监管核心的承诺。患者体验应成为监管决策的核心。 倾听多元声音，尤其是那些代表性不足的声音，能够及早洞察风险和不平等。这种洞察正是加强患者安全的力量所在，并有助于确保监管反映其所服务人群最关心的事项。 苏格兰患者安全专员Karen Titchener表示： 苏格兰各地民众已多次告诉我们，倾听并回应他们的医疗保健体验是多么重要。患者和家属是自己经历的专家，他们的见解有助于塑造更安全的药品、医疗器械和医疗保健系统。 我欢迎MHRA（英国药品和健康产品管理局）承诺扩大参与范围，让患者更早参与决策。有意义的参与有助于确保监管决策不仅以临床证据为依据，还以人们的现实生活为依据。 致编辑的说明 MHRA负责监管英国的药品、医疗器械和输血用血液成分。 阅读《2026–2030年患者与公众参与和互动计划》 MHRA的患者与公众参与委员会将审查该计划的实施进展。 患者与公众社区成立于2024年10月。它汇集了患者、患者组织和慈善机构，为MHRA的工作和政策制定提供信息。 媒体垂询，请联系 newscentre@mhra.gov.uk 或致电 020 3080 7651。 完
正文 · 英文原文
Press release MHRA sets out approach to strengthen patient and public involvement and engagement in medicines and medical device regulation New plan will broaden participation and make clearer how patient experience informs regulatory decisions, safety and innovation From: Medicines and Healthcare products Regulatory Agency Published: 5 November 2026 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. Under the plan, the MHRA will: Strengthen feedback, monitoring and reporting so people can see how their contributions have influenced the MHRA’s work. Expand membership of its Patient and Public Community to better reflect the diversity of the UK population. Use deliberative engagement to ensure patient and public perspectives shape how the benefits and risks of medicines are assessed. Involve patients and the public in work to make medicines information clearer and more accessible. Work with the National Institute for Health and Care Excellence (NICE) to reduce duplication in patient involvement evidence used for regulatory and health technology assessments. Professor Anthony Harnden, Chair of the MHRA, said: Our Patient and Public Involvement and Engagement Plan is a vital evolution in the way we connect and listen to patients and the public at a time when the dynamic landscape of medicines and medical devices regulation is changing rapidly. Bringing those who matter most into the heart of our regulatory and decision-making processes, patients and the public can tell us how treatments affect their everyday lives, what benefits they value most and where information needs to be clearer. That insight helps us ask better questions and make better-informed regulatory decisions. Through this plan, we will involve people earlier, hear from a broader range of communities and patient demographics and explain how their contributions have influenced our work. Patient involvement has already helped shape the MHRA’s work on rare diseases. A dedicated advisory group of 23 patient representatives has contributed to the MHRA’s Rare Disease Consortium, helping identify priorities, informing draft guidance and spearheading medicines repurposing. Mercy Jeyasingham MBE, MHRA Non-Executive Director and Chair of the People and Public Engagement Committee, said: This plan combines ambition with practical and achievable commitments to strengthen how we involve patients and the public in our work. A consistent approach across the agency will help ensure that people’s experiences inform our work and that those contributing understand how their input has been used. The People and Public Engagement Committee will oversee progress, helping turn these commitments into meaningful and lasting improvements. Professor Henrietta Hughes OBE, Patient Safety Commissioner for England, said: I welcome this plan and its commitment to putting patients’ voices at the heart of regulation. Patient experience should be central to regulatory decisions. Listening to a diverse range of voices, particularly those that are under-represented, provides early insight into risks and inequalities. This insight is what strengthens patient safety and helps ensure regulation reflects what matters most to the people it serves. Karen Titchener, Patient Safety Commissioner for Scotland, said: People across Scotland have repeatedly told us how important it is that their experiences of healthcare are listened to and acted upon. Patients and families are experts in their own experiences, and their insights can help shape safer medicines, medical devices and healthcare systems. I welcome the MHRA’s commitment to broadening participation and involving patients earlier in decision-making. Meaningful engagement helps ensure that regulatory decisions are informed not only by clinical evidence, but also by the realities of people’s lives. Notes to editors The MHRA regulates medicines, medical devices and blood components for transfusion in the UK. Read the Patient and Public Involvement and Engagement Plan 2026–2030 The MHRA’s People and Public Engagement Committee will review progress in delivering the plan. The Patient and Public Community was established in October 2024. It brings together patients, patient organisations and charities to inform the MHRA’s work and policy development. For media enquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651. ENDS