患者参与药物监管的国际经验与启示  

International experience and enlightenment of patient engagement in drug regulation

作　　者：邬镜净 曾凯欣 杨雨菲 田梦妍 董方正 张怡萌 李军[1,2] 茅宁莹[1,2] WU Jingjing;ZENG Kaixin;YANG Yufei;TIAN Mengyan;DONG Fangzheng;ZHANG Yimeng;LI Jun;MAO Ningying(School of International Medicine Business,China Pharmaceutical University,Nanjing 211198,China;Research Center of National Drug Policy&Ecosystem,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学国际医药商学院,南京211198 [2]中国药科大学国家药物政策与医药产业经济研究中心,南京211198

出　　处：《中国药房》2025年第8期908-913,共6页China Pharmacy

基　　金：江苏省社科基金一般专项资助项目(No.22JZB002);江苏省高校哲学社会科学研究项目(No.2021SJA0075);江苏高校哲学社会科学研究重大项目(No.2024SJZD128);2024年江苏省研究生科研创新计划(No.KYCX24_1050)。

摘　　要：目的为完善我国患者参与药物监管的路径和体系建设提供建议。方法通过梳理美国、欧盟和日本等国家或地区促进患者参与药物监管的举措和经验,总结国际上患者在药物监管全过程中的角色扮演和作用发挥,再结合我国患者参与药物监管的发展现状和现存挑战,提出完善我国患者参与药物监管路径和体系建设的具体建议。结果与结论随着国际上不断提升对患者参与药物监管这一策略的重视程度,美国、欧盟和日本等国家或地区在患者参与药物监管方面出台了较为明晰的政策法规并设置了专管部门,形成了多样化的患者参与药物监管的路径和模式,患者可以通过研讨会议或直接参与决策等形式参与到药物监管环节中,用自身体验和专业知识对药物监管流程进行优化。目前,我国的患者参与药物监管工作尚处于以临床价值为导向的药物研发层面,也未出台指导患者参与药物监管的政策文件。建议我国在现有政策体系的基础上,进一步加强患者参与保障体系建设,完善患者参与药物监管的能力建设和路径模式,推动我国患者参与药物监管持续向前发展。OBJECTIVE To provide suggestions for improving the path and system construction of patient engagement in drug regulation in China.METHODS By reviewing initiatives and experiences from the United States(U.S.),European Union(EU),and Japan in promoting patient engagement,this study summarizes the roles and contributions of patients in the entire drug regulatory process internationally.Combining China’s current progress and challenges in patient engagement,specific proposals are formulated to refine regulatory pathways and institutional systems.RESULTS&CONCLUSIONS With growing global emphasis on patient engagement as a regulatory strategy,countries or regions such as the U.S.,EU,and Japan have established clear policies,designated oversight agencies,and developed diversified pathways for patient engagement.Patients contribute to regulatory processes through advisory meetings,direct decision-making roles,and leveraging lived experiences and expertise to optimize drug evaluation and monitoring.In contrast,China’s patient engagement remains primarily limited to clinical value-oriented drug development,lacking formal policy guidance.It is recommended that China,based on its existing policy system,further strengthen the construction of a safeguard system for patient engagement,improve the capacity building and pathway models for patient participation in pharmaceutical regulation,and promote the continuous development of patient engagement in pharmaceutical regulation in our country.

关 键 词：患者参与 药物监管 国际经验 路径 启示 

分 类 号：R95[医药卫生—药学]