摘要
目的与世界草药发展相适应,认识中药的基本特征和上市注册的类型。方法比较世界卫生组织关于草药药品的含义特点,以及欧盟、美国和日本关于草药、植物药和汉方药的注册模式,发现中国官方目前关于中药的定义和注册分类与世界主流的规定存在一定差异。结果与结论中药属于世界卫生组织定义的草药药品;中药与化学药品注册应一体化;根据草药药品的基本特征建立指导原则;进一步考虑经典的传统中药的简化注册。
Objective The characterization of traditional Chinese medicines（TCM） and registration types for marketing is discussed,in accordance with the development of herbal medicines in the world.Methods It is found that the official definition for TCM and classification for registration in China is quite different from the mainstream of the world at present,compared with definitions for herbal medicines proposed by World Health Organization（WHO）,and registration descriptions about herbal medicines,botanical drug,and kampo medicines proposed by EU,USA,and Japan,respectively.Results and Conclusion Herbal medicines,defined by WHO,include TCM.Registration types of TCM and chemical drugs are united.Guidance should be established on Characteristics of Herbal Medicines.Registration process for classic traditional Chinese medicines could be simplified further.
出处
《中国药事》
CAS
2011年第1期25-28,共4页
Chinese Pharmaceutical Affairs
基金
国家药品审评中心主持的科技部项目(编号2006BA121B00)
关键词
中药
草药
注册
新药
traditional Chinese medicines
herbal medicines
registration
new drugs
