香港中成药注册管理工作概述

Summary of Registration Management of Proprietary Chinese Medicines in Hong Kong

目的让更多的人了解香港中成药注册审评的规定与要求,以促进香港中药及中药新药的研究与开发。方法对香港中成药注册的政策法规和香港中成药过渡性注册及非过渡性注册的有关规定进行介绍和分析。结果与结论香港中成药注册管理虽起步较晚,但规范性文件已经制订,其注册管理工作将愈加严格和规范。

Objective To let more people know the stipulations and requirements of investigation during registration of proprietary Chinese medicines, and promote the research and development of traditional Chinese medicines in Hong Kong. Methods Introducing and analyzing the associated laws and regulations about registration of proprietary Chinese medicines （pCms）. Results and Conclusions Though the start time of registration management in Hong Kong is late, the laws and regulations have been issued, the management will be stricter.