美国药品标识全生命周期管理研究与启示

中国药物警戒 ›› 2018, Vol. 15 ›› Issue (6): 333-338.

美国药品标识全生命周期管理研究与启示

于金冉, 王宏伟, 王艺芳, 杨悦^*

沈阳药科大学工商管理学院,辽宁沈阳 110016

收稿日期:2018-08-03 修回日期:2018-08-03 出版日期:2018-06-15 发布日期:2018-08-03
通讯作者: 杨悦,女,教授,博导,药事管理与法规政策及临床药学。E-mail：yyue315@vip.126.com
作者简介:于金冉,女,在读硕士,药事管理与法规政策。
基金资助:
原国家食品药品监督管理总局课题（20170012）：药品上市后说明书管理研究

Lifecycle Management of American Drug Labeling and Its Implication

YU Jin-ran, WANG Hong-wei, WANG Yi-fang, YANG Yue^*

School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2018-08-03 Revised:2018-08-03 Online:2018-06-15 Published:2018-08-03

摘要/Abstract

摘要： 目的为完善我国药品说明书及其他标识监管制度及建立动态管理体系提供参考建议。方法通过对美国药品标识相关法律、法规、指南的研究,分析其科学性。结果与结论 借鉴美国药品标识的管理模式,完善我国药品标识的法律体系,强化标识按药品分类差别管理,针对读者对象调整标识内容及表述,改进药品上市后标识修订程序,仿制药标识原则上应与原研药标识一致。细化备案制安全性信息的相关规定,严格设定和实施标识违法处罚,提高企业修订标识的主动性,建立全生命周期的药品标识动态调整机制。

关键词: 药品标识, 全生命周期管理, 制度体系

Abstract: Objective To put forward suggestions for improving drug labeling regulatory system and establishing a dynamic management system for drug labeling. Methods By studying American laws, regulations and guidelines of drug labeling, its scientific points were analyzed. Results and Conclusion It was suggested that we should learn the management pattern of America, improve the legal system of drug labeling in China, strengthen the classification management of labeling, set different labeling types based on different readers, improve the post-market drug labeling revision procedure. Generic drugs labeling should be consistent with new drugs labeling in principle. Penalties for drug labeling violation should be enhanced in order to promote the initiative of drug companies to revise labeling, accelerate the update of drug labeling, and finally form a dynamic adjustment mechanism throughout the drug lifecycle.

Key words: drug labeling, lifecycle management, regulatory system

中图分类号:

于金冉, 王宏伟, 王艺芳, 杨悦. 美国药品标识全生命周期管理研究与启示[J]. 中国药物警戒, 2018, 15(6): 333-338.

YU Jin-ran, WANG Hong-wei, WANG Yi-fang, YANG Yue. Lifecycle Management of American Drug Labeling and Its Implication[J]. Chinese Journal of Pharmacovigilance, 2018, 15(6): 333-338.

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