Drug Evaluation Research 2017;40(3):285-291

doi:10.7501/j.issn.1674-6376.2017.03.001

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

Huilai XIAO

Keywords

European Union (EU); herbal medicine; assessment of clinical safety; assessment of clinical efficacy; guideline

Country

China

Language

Chinese

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.