药品标识缺陷法律问题研究

中国药物警戒 ›› 2014, Vol. 11 ›› Issue (9): 542-546.

药品标识缺陷法律问题研究

李名石, 杨悦^*

沈阳药科大学工商管理学院,辽宁沈阳 110016

收稿日期:2014-05-28 修回日期:2016-02-03 出版日期:2014-09-08 发布日期:2016-03-02
通讯作者: 杨悦,女,教授,博士生导师,药事法规与药品政策。
作者简介:李名石,女,在读硕士,药事法规与药品政策。

Legal Issues about Drug Labeling Defects

LI Ming-shi, YANG Yue^*

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

Received:2014-05-28 Revised:2016-02-03 Online:2014-09-08 Published:2016-03-02

摘要/Abstract

摘要： 目的提出完善药品标识缺陷相关法律的建议,为我国药品标识管理提供参考。方法查阅国内外相关法律文件,从法律责任的角度分析讨论药品标识管理方式。结果与结论我国应逐步强化药品标识监管,明确药品标识缺陷定义、认定标准和法律责任等条款, 出台更加细节化的法律文件指导,为企业药品标识撰写和修订提供依据,使药品能够安全、有效、科学地使用。

关键词: 标识, 缺陷, 警示缺陷, 法律责任

Abstract: ObjectiveTo propose suggestions to improve drug labeling management of China, provide reference for regulation revise. MethodsBy collecting current labeling documents in CFDA and FDA, analyze drug labeling management from legal perspective. Resultsand ConclusionCurrently, our country should clearly define drug labeling defects, make sure the standard of how to recognize labeling defects and the labeling defects liability, take steps to revise the regulations to guide drug labeling design, make the drug use safer and more effective.

Key words: labeling, defect, warning defect, legal liability

中图分类号:

R951

李名石, 杨悦. 药品标识缺陷法律问题研究[J]. 中国药物警戒, 2014, 11(9): 542-546.

LI Ming-shi, YANG Yue. Legal Issues about Drug Labeling Defects[J]. Chinese Journal of Pharmacovigilance, 2014, 11(9): 542-546.

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