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新版《进口药材管理办法》解读
引用本文:刘丽娜,张体灯,金红宇,王海南,马双成.新版《进口药材管理办法》解读[J].中国药事,2019,33(8):846-850.
作者姓名:刘丽娜  张体灯  金红宇  王海南  马双成
作者单位:中国食品药品检定研究院, 北京 100050,国家药品监督管理局, 北京 100037,中国食品药品检定研究院, 北京 100050,国家药品监督管理局, 北京 100037,中国食品药品检定研究院, 北京 100050
摘    要:目的:对进口药材管理沿革进行梳理归纳,为相关人员提供参考。方法:分析进口药材的情况、进口药材监管历史以及进口药材标准,比较《进口药材管理办法(试行)》(2005年)与《进口药材管理办法》(2019年)的异同点。结果与结论:修订后的《进口药材管理办法》,使得进口程序大大简化,将会让境外的优质药材更好地为中医药所用,满足临床需求。

关 键 词:进口药材  管理  质量标准  沿革
收稿时间:2019/6/20 0:00:00

Introduction of the Revised Provisions for the Administration of Imported Herbal Materials
Liu Lin,Zhang Tideng,Jin Hongyu,Wang Hainan and Ma Shuangcheng.Introduction of the Revised Provisions for the Administration of Imported Herbal Materials[J].Chinese Pharmaceutical Affairs,2019,33(8):846-850.
Authors:Liu Lin  Zhang Tideng  Jin Hongyu  Wang Hainan and Ma Shuangcheng
Institution:National Institutes for Food and Drug Control, Beijing 100050, China,National Medical Products Administration, Beijing 100037, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Medical Products Administration, Beijing 100037, China and National Institutes for Food and Drug Control, Beijing 100050, China
Abstract:Objective:To sort out and summarize the evolution of administration of imported medicinal materials in order to provide references for relevant personnels. Methods:Situation, regulatory history and standards of imported herbal materials were analyzed. The similarities and differences between Provisions for the Administration of Imported Herbal Materials (Interim) (2005) and Provisions for the Administration of Imported Herbal Materials (2019) were compared. Results and Conclusion:The implementation of the revised Provisions for the Administration of Imported Herbal Materials has greatly simplified the import procedures and will enable the better use of high-quality imported herbal materials for traditional Chinese medicine to meet the clinical needs.
Keywords:imported herbal materials  administration  quality standards  evolution
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