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Analysis on value of Community Herbal Monograph in registration of traditional Chinese medicinal products in Europe
Qu L.-P.1; Shi Q.1; Zeng H.-M.2; Wang Y.-T.3; Zou W.-J.1
2017
Source PublicationChinese Traditional and Herbal Drugs
Volume48Issue:9Pages:1916
Abstract

The Community Herbal Monograph (CHM) is an official document which reflects the scientific opinion of European Medicines Agency (EMA) and plays an important role in technical harmonization of the herbal medicinal products. The role of CHM is very similar with the centralized procedure in the EU level as it represents the technical coordination results of the assessment about safety and efficacy of herbal medicine. The monograph and national procedure, decentralized procedure, and mutual recognition procedure together constitute the coexistence characteristic of centralization and decentralization of the EU medical legislation. The CHM and the traditional herbal medicine registration also constitute the core content of Directive 2004/24/EC in the EU and member state level respectively. And the CHM plays an important role in the registration of traditional herbal medicinal products in the EU member state. However, it has not yet been fully studied by domestic experts and scholars. This paper makes intensive studies on the value of CHM and analyzes the application of monograph in traditional herbal medicine registration. The purpose is to clarify the value and importance of CHM in the registration of traditional Chinese medicine in EU and to provide reference for the Chinese enterprises which are aspiring to open up the EU market. © 2017, Editorial Office of Chinese Traditional and Herbal Drugs. All right reserved.

KeywordChinese Materia Medica Community Herbal Monograph Directive 2004/24/ec Eu Registration Traditional Chinese Medicinal Products
DOI10.7501/j.issn.0253-2670.2017.09.032
URLView the original
Language中文
The Source to ArticleScopus
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Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
Affiliation1.Chengdu University of Traditional Chinese Medicine, Chengdu, 610041, China
2.Chengdu Di'ao Pharmaceutical Group, Chengdu, 610065, China
3.Institute of Chinese Medical Sciences, University of Macau, Macau, 999078, Macau
Recommended Citation
GB/T 7714
Qu L.-P.,Shi Q.,Zeng H.-M.,et al. Analysis on value of Community Herbal Monograph in registration of traditional Chinese medicinal products in Europe[J]. Chinese Traditional and Herbal Drugs,2017,48(9):1916.
APA Qu L.-P.,Shi Q.,Zeng H.-M.,Wang Y.-T.,&Zou W.-J..(2017).Analysis on value of Community Herbal Monograph in registration of traditional Chinese medicinal products in Europe.Chinese Traditional and Herbal Drugs,48(9),1916.
MLA Qu L.-P.,et al."Analysis on value of Community Herbal Monograph in registration of traditional Chinese medicinal products in Europe".Chinese Traditional and Herbal Drugs 48.9(2017):1916.
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