欧盟患者药品说明书管理体系研究及启示  

Study on patients’medicine instruction regulatory system in the European Union and the enlightenment

作　　者：袁思晗 蒋蓉[1] 郑妤婕 李海琦 陈艺瑄 邵蓉[1] YUAN Sihan;JIANG Rong;ZHENG Yujie;LI Haiqi;CHEN Yixuan;SHAO Rong(Institute of Drug Regulatory Science,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学药品监管科学研究院,南京211198

出　　处：《中国药房》2025年第3期269-274,共6页China Pharmacy

基　　金：国家自然科学基金项目(No.72304280)。

摘　　要：目的 为建立与完善我国患者药品说明书管理体系提供参考。方法 通过检索欧洲药品管理局(EMA)官方网站及相关文献,介绍欧盟患者药品说明书的定义、基本性质与项目内容,从专职管理部门设置、审批与变更程序、内容可读性、信息可及性方面分析欧盟患者药品说明书管理体系的特点;同时,分析我国患者药品说明书试点情况以及分类管理路径、内容可读性与信息时效性方面存在的问题,并提出建议。结果与结论 欧盟设有药品说明书专职管理部门;患者药品说明书审批与变更程序清晰,内容可读性要求详细,建立有患者参与的可读性验证程序,采取多渠道且及时的信息公开形式。建议我国建立专业人士药品说明书与患者药品说明书分类管理机制;引导多方参与患者药品说明书设计,细化可读性要求;健全药品说明书信息公开机制,提高用药信息时效性。OBJECTIVE To provide reference for the establishment and improvement of the regulatory system of patients’medicine instructions in China.METHODS Through searching the official website of the European Medicines Agency(EMA)and related literature,the definition,basic nature,and content of patients’medicine instructions in the European Union were introduced,and the characteristics of the management system of patients’medicine instructions in the European Union were analyzed in terms of the management department,approval and change procedures,readability requirements and information accessibility requirements.At the same time,the pilot situation of patients’medicine instructions in China,as well as problems in the paths of classification and management,readability of content,and information timeliness were analyzed to put forward suggestions.RESULTS&CONCLUSIONS European Union had a dedicated department for the management of medicine instructions;the approval and change procedures for patients’medicine instructions were clear,the readability requirements were detailed,the readability verification program with patient participation was established,and multi-channel and timely information disclosure was adopted.It is recommended that China establish a mechanism to categorize and manage professionals’and patients’medicine instructions,guide multiple parties to participate in the design of patients’medicine instructions and refine the readability requirements,and improve the mechanism for disclosure of medicine instructions to enhance the timeliness of medication information.

关 键 词：患者药品说明书 欧盟 包装说明书 可读性 用药安全 

分 类 号：R95[医药卫生—药学]