摘要
2011年，欧盟2004／24／EC指令规定的传统草药简化注册申请7年过渡期即将期满。本文通过对欧盟传统草药监管趋势变化的研究，对欧盟草药产品委员会（HMPC）增加欧盟草药产品专论和目录、完善简化注册申请程序、扩大简化注册申请范围、加强国际交流合作等多方面进行了探讨，旨在促进我国中药产品顺利进入欧盟药品市场。
The transient period of 7 years which is regulated in 2004/24/EC Director is due to 2011. This paper discussed the changing of traditional herbal drug regulation, the increasing of herbal monographs and lists, extending the scope of the simplified registration procedure in European Union. The purpose was to promote traditional Chinese medicine to enter the market.
出处
《国际中医中药杂志》
2011年第5期417-420,共4页
International Journal of Traditional Chinese Medicine
关键词
传统草药
监管
简化注册申请
发展趋势
Traditional herbal drug
The regulatory
Simplified registration
The trends
