欧洲联盟草药专论和草药目录审核和修订程序介绍

Introduction of procedure for review and revision of European Union herbal monographs and European Union list entries

欧洲药品局(EMA)于2017年10月发布了"欧洲联盟草药专论和草药目录审核和修订程序"。该文件详细描述了欧洲联盟草药专论和草药目录的修订过程,包括审核新数据、判断新数据与需要修订专论的相关性和修订。详细介绍该文件的主要内容,期望对我国中草药的医学评价有所启迪。

The EMA issued the ＂Procedure for the review and revision of European Union herbal monographs and European Union list entries＂ in October 2017. The document detailed the revision process of European Union herbal monographs and European Union list entries, including reviewing new data, judging the relevance of new data and the need of revision of monograph and revising. This paper introduced the contents of this document in detail, which is expected to enlighten the medical evaluation of Chinese herbal medicines.