| 欧盟传统草药产品监管发展动态研究 |
| |
| 引用本文： | 李秦川,陈永法.欧盟传统草药产品监管发展动态研究[J].国际中医中药杂志,2011,33(5):417-420. |
| |
| 作者姓名： | 李秦川 陈永法 |
| |
| 作者单位： | 1. 中国药科大学国际医药商学院,南京,211198
2. 中国药科大学国际医药商学院 |
| |
| 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.
|
| 关 键 词： | 传统草药 监管 简化注册申请 发展趋势 |
The regulatory developments of traditional herbal medicinal products in European Union |
| |
| LI Qin-chuan,CHEN Yong-fa.The regulatory developments of traditional herbal medicinal products in European Union[J].International Journal of Traditional Chinese Medicine,2011,33(5):417-420. |
| |
| Authors: | LI Qin-chuan CHEN Yong-fa |
| |
| Abstract: | 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. |
| |
| Keywords: | Traditional herbal drug The regulatory Simplified registration The trends |
| 本文献已被 万方数据 等数据库收录！ |
