Key issues in registration of Chinese materia medica in European Union based on "Community Herbal Monograph" / 中草药
Chinese Traditional and Herbal Drugs
;
(24): 3509-3514, 2014.
Article
in Chinese
| WPRIM
| ID: wpr-854711
ABSTRACT
The European Legislation Directive 2004/24/EC introduced a simplified registration procedure for traditional herbal medicinal products, which has largely reduced the difficulty of registration for herbal medicinal products. The traditional Chinese medicinal products still face a lot of challenges such as 15-year minimum medicinal use requirements in the European Union (EU) and limited self-medication indication categories and administration modes. As the criteria for a Community Herbal Monograph assessment is in many aspects similar to assessment of safety and efficacy aspects in the registration of a traditional herbal medicinal product, this article has made a systematic evaluation of the latest assessment of Community Herbal Monograph and presented the key issues in traditional Chinese medicinal product registration based on a Community Herbal Monograph perspective. The results from this article will ultimately contribute to supporting and assisting the non-European traditional herbal medicinal product registration in EU.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
Chinese Traditional and Herbal Drugs
Year:
2014
Type:
Article
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