患者参与在药品监管中的作用--美欧日药品监管机构经验启示  

The Role of Patient Engagement in Drug Regulation:Insights from the Experiences of Drug Regulatory Agencies in the United States,Europe,and Japan

作　　者：唐凌 艾星 宋媛媛 杨志敏 TANG Ling;AI Xing;SONG Yuanyuan;YANG Zhimin(Center for Drug Evaluation of NMPA,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国医药导刊》2025年第1期7-13,共7页Chinese Journal of Medicinal Guide

摘　　要：患者参与药物开发和药品监管是公共卫生领域一个动态且不断发展的议题,是患者或其代表主动介入决策过程及流程的一种实践,国际上目前就“患者参与”尚无统一定义。“以患者为中心的药物研发”强调制药公司、研究机构以及政府监管者与患者之间的多方合作,倡导深入聆听患者意见,以促进药物研发的各个环节。患者参与有助于加强监管意见的深度和质量,提升监管决策的科学性、透明度和公众信任,促进监管机构与患者群体之间的相互尊重。患者视角在药物研发过程中可补充重要信息,并对药品审评审批产生影响。美国、欧盟、日本等创新活跃的国家或地区在促进患者参与药品监管,以及建立患者与监管机构之间的沟通渠道方面积累了丰富的经验。本研究在梳理美国、欧盟、日本药品监管机构“患者参与”实施情况的基础上,总结当前我国药品监管机构在“以患者为中心的药物研发”方面开展的工作,充分借鉴国际已有经验,并为“患者参与”在我国未来的发展和有效实施提出建议,以期未来患者的声音能更科学、更常规地融入我国药品监管活动。Patient engagement in drug development and drug regulation is a dynamic and evolving topic in the field of public health.It is a practice where patients or their representatives actively intervene in the decision-making process and procedures.Currently,there is no unified international definition for"patient engagement"."Patient-focused drug development"emphasizes the multi-party coop-eration among pharmaceutical companies,research institutions,government regulators,and patients.It advocates for in-depth listening to patients'opinions to promote every aspect of drug development.Patient engagement helps to enhance the depth and quality of regula-tory opinions,improve the scientific nature,transparency,and public trust of regulatory decisions,and promote mutual respect between regulatory agencies and patient groups.The patient's perspective supplements important information during the drug development process and has an impact on drug review and approval.Innovation-active countries or regions such as the United States,the European Union,and Japan have accumulated rich experience in promoting patient engagement in drug regulation and establishing communication chan-nels between patients and regulatory agencies.Based on a review of the implementation of"patient engagement"by drug regulatory agen-cies in the United States,the European Union,and Japan,this study summarizes the current work carried out in China's drug regulatory agencies on"patient-focused drug development".By fully drawing on existing international experience,it puts forward suggestions for the future development and effective implementation of"patient participation"in China,to help that patients'voices can be more scientifi-cally and routinely integrated into China's drug regulatory activities in the future.

关 键 词：患者参与 以患者为中心 药物研发 药品监管 法规 

分 类 号：R951[医药卫生—药学]