Analysis of difficult problems on European Union laws and regulations of traditional herbal medicinal products.
10.19540/j.cnki.cjcmm.20170913.002
- Author:
Li-Ping QU
1
;
Xiao-Qun ZHANG
1
;
Yan XIONG
1
;
Yi-Tao WANG
2
;
Wen-Jun ZOU
1
Author Information
1. College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 610041, China.
2. Institute of Chinese Medical Sciences, University of Macau, Macau 999078, China.
- Publication Type:Journal Article
- Keywords:
Community Herbal Monograph and List Entries;
Directive 2004/24/EC;
EU registration for traditional Chinese medicine;
marketing authorization procedures
- From:
China Journal of Chinese Materia Medica
2017;42(20):4040-4044
- CountryChina
- Language:Chinese
-
Abstract:
Registration of Chinese patent medicine in European Union (EU) is of great significance to the internationalization of traditional Chinese medicine as EU market acts as an important position in the global botanical market. In retrospect, the domestic studies on EU regulations of traditional herbal medicinal products have been conducted for more than 10 years, but there is still some cognitive bias and lack of research. In this paper, a review of the relevant research progress and the main misunderstanding problems about Directive 2004/24/EC, like the centralized and decentralized supervision system of traditional herbal medicinal products in the EU, marketing authorization procedures for traditional herbal medicinal products, Community Herbal Monograph and List Entries, would be systematically analyzed, so as to provide reference for the registration of Chinese patent medicine in EU.
