[关键词]
[摘要]
欧盟(European Union,EU)于2016年7月发布了《在欧盟草药专论编写中评估公认的和传统的草药产品临床安全性和有效性的指导原则(第一次修订版)》。其中最值得注意的是,草药产品申请注册时可用文献资料替代试验资料,并且可根据文献资料科学性不同,获准不同的适应证。介绍该指导原则的主要内容,期望对我国的中药和植物药研究及其监管有所帮助。
[Key word]
[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 medicinal products 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.
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