日本电子药品说明书管理实践及启示  

Practice and inspiration for management of electronic drug product package insert in Japan

作　　者：李海琦 蒋蓉[1,2] 郑妤婕 袁思晗 陈艺瑄 邵蓉 LI Hai-qi;JIANG Rong;ZHENG Yu-jie;YUAN Si-han;CHEN Yi-xuan;SHAO Rong(Institute of Drug Regulatory Science,China Pharmaceutical University,Nanjing JIANGSU 211198,China;Key Laboratory of Drug Regulatory Innovation and Evaluation,National Medical Products Administration,Nanjing JIANGSU 211198,China;Mudi Meng Honors College,China Pharmaceutical University,Nanjing JIANGSU 211198,China)

机构地区：[1]中国药科大学药品监管科学研究院,江苏南京211198 [2]国家药品监督管理局药品监管创新与评价重点实验室,江苏南京211198 [3]中国药科大学孟目的学院,江苏南京211198

出　　处：《中国新药与临床杂志》2024年第12期904-910,共7页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：日本以立法的形式迅速推进了药品说明书的电子化,建立了统一权威的电子药品说明书管理平台,明确由药品上市许可持有人(MAH)承担电子药品说明书全生命周期管理的主体责任,并详细规范了MAH进行电子药品说明书发布与变更的程序。目前我国也正积极推进电子药品说明书的试点和实施,但仍存在电子药品说明书定义模糊、管理平台不统一、数据来源难保障、信息更新不及时等问题。建议我国应出台相关政策,明确电子药品说明书定义,建立统一权威的电子药品说明书管理平台;落实MAH电子药品说明书发布和更新的主体责任;同时考虑全民数字化水平差异,有序推进电子药品说明书实施。Japan has rapidly advanced the electronicization of drug product package insert through legislation,establishing a unified and authoritative electronic package insert management platform;it has also clarified that marketing authorization holder(MAH)is the main responsible party for the entire life cycle of electronic package insert,and has specified the procedures for the MAH to release and revise electronic package insert.China has actively pushed forward the pilot and implementation of electronic drug product package insert.However,there are still problems such as vague definition of electronic package insert,inconsistent management platforms,difficulty in ensuring data sources,and insufficient timeliness of information updates.It is suggested that the definition of electronic drug product package insert should be clarified,a unified and authoritative electronic package insert management platform should be established,the responsibility of MAH for releasing and revising electronic package insert should be fully implemented,and the implementation of electronic package insert should be carried out in an orderly manner while considering the differences in digitalization levels among the public.

关 键 词：电子药品说明书 日本 上市许可持有人 

分 类 号：R95[医药卫生—药学]