日本药品再评价制度介绍

宋春黎, 牛剑钊, 张启明, 许鸣镝*

中国药学杂志 ›› 2014, Vol. 49 ›› Issue (12) : 1087-1091.

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中国药学杂志
PDF(1171 KB)
中国药学杂志 ›› 2014, Vol. 49 ›› Issue (12) : 1087-1091. DOI: 10.11669/cpj.2014.12.020
药事管理

日本药品再评价制度介绍

  • 宋春黎, 牛剑钊, 张启明, 许鸣镝*
作者信息 +

Introduction of Reevaluation of Generic Drug in Japan

  • SONG Chun-li, NIU Jian-zhao, ZHANG Qi-ming, XU Ming-di*
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文章历史 +

摘要

目的 为我国仿制药质量一致性评价工作提供参考。方法 介绍日本药品再评价, 并对其中可借鉴内容进行总结。结果与结论 日本药品再评价经过多年探索, 积累了许多有益的经验, 对我国的仿制药质量一致性评价工作具有借鉴意义。

Abstract

OBJECTIVE To provide references for the quality evaluation of generic drug in China. METHODS The process of reevaluation of generic drug in Japan was introduced and the conclusions of the useful points were made. RESULTS AND CONCLUSION The useful experiences from Japan are of great importance to China’s quality consistency evaluation of generic drug.

关键词

日本 / 仿制药 / 再评价

Key words

Japan / generic drug / reevaluation

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宋春黎, 牛剑钊, 张启明, 许鸣镝*. 日本药品再评价制度介绍[J]. 中国药学杂志, 2014, 49(12): 1087-1091 https://doi.org/10.11669/cpj.2014.12.020
SONG Chun-li, NIU Jian-zhao, ZHANG Qi-ming, XU Ming-di*. Introduction of Reevaluation of Generic Drug in Japan[J]. Chinese Pharmaceutical Journal, 2014, 49(12): 1087-1091 https://doi.org/10.11669/cpj.2014.12.020
中图分类号： R921   

参考文献

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