Analysis on value of Community Herbal Monograph in registration of traditional Chinese medicinal products in Europe / 中草药
Chinese Traditional and Herbal Drugs
; (24): 1916-1920, 2017.
Article
em Zh
| WPRIM
| ID: wpr-852829
Biblioteca responsável:
WPRO
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.
Texto completo:
1
Base de dados:
WPRIM
Medicinas Tradicionais:
Medicinas_tradicionales_de_asia
/
Medicina_china
Medicinas Complementares:
Homeopatia
Idioma:
Zh
Revista:
Chinese Traditional and Herbal Drugs
Ano de publicação:
2017
Tipo de documento:
Article