中国药房2025，Vol.36Issue(8)：908-913,6.DOI:10.6039/j.issn.1001-0408.2025.08.03
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
摘要
Abstract
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Key words
patient engagement/drug regulation/international experience/pathway/enlightenment分类
药学引用本文复制引用
邬镜净,曾凯欣,杨雨菲,田梦妍,董方正,张怡萌,李军,茅宁莹..患者参与药物监管的国际经验与启示[J].中国药房,2025,36(8):908-913,6.基金项目
江苏省社科基金一般专项资助项目(No.22JZB002) （No.22JZB002）
江苏省高校哲学社会科学研究项目(No.2021SJA0075) （No.2021SJA0075）
江苏高校哲学社会科学研究重大项目(No.2024SJZD128) （No.2024SJZD128）
2024年江苏省研究生科研创新计划(No.KYCX24_1050) （No.KYCX24_1050）
