日本化学药品先发品确定路径及管理模式简介

An introduction to the determination path and management model of chemical initial products in Japan

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。

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.