The suggestions on the entry of Chinese medicines into European Community monographs for traditional herbal medicinal products
10.3760/cma.j.issn.1673-4246.2011.05.008
- VernacularTitle:关于中药品种进入欧盟草药产品专论的几点建议
- Author:
Li JIN
;
Wei ZHANG
;
Junde LI
;
Ruixian ZHANG
;
Aijuan SHAO
;
Qian WANG
;
Jinghua FU
;
Yanan YUAN
;
Ming CHENG
- Publication Type:Journal Article
- Keywords:
Chinese medicines;
European Community monographs;
Directive 2004/24/EC;
Traditional herbal medicinal products
- From:
International Journal of Traditional Chinese Medicine
2011;33(5):412-416
- CountryChina
- Language:Chinese
-
Abstract:
Directive 2004/24/EC of the European Parliament and the Council entered into force on April 30th, 2004. After 7 years, there is no Chinese medicine to be registered successfully in European market as traditional herbal medicinal products. The thesis gives some ideas to tackle this problem. Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products (EMEA/HMPC/182320/2005) published by European Medicines Agency is an important guidance for traditional herbal products to enter European Community monographs. The thesis introduces and details the procedure as well as gives feasible suggestions about the procedure. It suggests that Chinese medicines enter European Community monographs first, and then apply the registration according to the directive 2004/24/EC. This is an easier access to European market.
