Introduction to EU's Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products / 药物评价研究
Drug Evaluation Research
;
(6): 285-291, 2017.
Article
in Chinese
| WPRIM
| ID: wpr-513535
ABSTRACT
The European Union released Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinalproducts rev.1 in July 2016.It is noteworthy in the guideline that the test data can be replaced by the literature when the herbal medicine products are applied for registration and according to the scientific strength of the literature,different indications can be approved.This paper introduces the main contents of the guideline and is expected to inspire the research and supervision of Chinese materia medica and phytomedicine in China.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Practice guideline
Language:
Chinese
Journal:
Drug Evaluation Research
Year:
2017
Type:
Article
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