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日本化学药品先发品确定路径及管理模式简介

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本文通过介绍日本厚生劳动省对化学药品先发品的确定路径及管理模式,为我国拟选择日本上市先发品作为参比制剂的仿制药研发企业提供参考,同时为监管机构对我国化学仿制药参比制剂的确定提供参考。
An introduction to the determination path and management model of chemical initial products in Japan
Based on the introduction to the determination path and management model of chemical initial products in the Ministry of Health,Labour and Welfare of Japan,this article provides reference for generic drug research and development enterprises in China that intend to select Japanese listed initial products as reference preparations and provides reference for regulatory agencies to determine the reference preparations of chemical generic drugs in China.

Japaninitial productspath determinationmanagement model

刘意林、宁黎丽、李芳、安娜、哈莉莉、郭志鑫

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国家药品监督管理局药品审评中心,北京 100022

日本 先发品 确定路径 管理模式

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(10)