Analysis of simplified registration of traditional herbal medicinal products in European Union
10.3760/cma.j.cn115398-20210508-00049
- VernacularTitle:欧盟传统草药产品简易注册分析
- Author:
Huimin HU
1
,
2
;
Longhui YANG
;
Yong TAN
;
Dongmei GUO
;
Zixu WANG
;
Jing'an BAI
;
Jie LIN
Author Information
1. 中国中医科学院中医临床基础医学研究所，北京
2. 100700
- Keywords:
European Union;
Traditional herbal medicinal products;
Simplified registration;
Registration administration;
Registration documents
- From:
International Journal of Traditional Chinese Medicine
2022;44(1):6-11
- CountryChina
- Language:Chinese
-
Abstract:
Europe occupies an important position in the world herbal medicine market. The registration of Traditional Chinese Medicine (TCM) in EU is of great significance to the internationalization of TCM. The European Medicines Agency (EMA) has designed a relatively complete management system and regulatory guidelines for the registration and supervision of herbal medicinal products. The promulgation of the DIRECTIVE 2004/24/EC (2004 / 24 / EC) indicates that TCM could enter the EU market through simplified registration. Based on the registration conditions, registration authority and document guideines of Traditional Herbal Medicinal Products (THMPs) in EU, this paper analyzes the application requirements of simple registration of traditional herbal products in EU, and provides suggestions for the simplified registration of TCM in EU according to the registration requirements of medicinal history, quality requirements and application data format.
