中药饮片不符合药品标准对安全性有效性影响的判断--《药品管理法》第一百一十七条第二款适用的探讨

Evaluation of Effect of Chinese Herbal Pieces not Conforming to Drug Standards on their Safety and Effectiveness--Discussion of application of the Second Paragraph of Article 117 of the Drug Administration Law

本文对《药品管理法》第一百一十七条第二款关键词进行了字面和体系解释,围绕中药饮片不符合药品标准对安全性和有效性影响的判断原则,结合2013~2018年原国家食品药品监督管理总局发布中药饮片抽检不合格公告品种和《中国药典》收载的中药材、中药饮片标准检验项目进行了关联分析,提出了对安全性、有效性影响的主要分类和判断原则,并列举了需要继续研究的问题。

This paper provides a literal and syste matic interpretation for the second paragraph of Article 117 of the Drug Administration Law.Association analysis is carried out on Chinese herbal pieces with substandard results from sampling and testing conducted by the former China Food and Drug Administration from 2013 to 2018 and the testing items of drug standards for Chinese medicinal materials and Chinese herbal pieces contained in the Chinese Pharmacopoeia.Finally,we put forward major factors affecting the safety and effectiveness of Chinese herbal pieces and their evaluation principles,and listed issues that need to be further discussed.