国家基本药物抽验管理工作现状分析及展望
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篇名: 国家基本药物抽验管理工作现状分析及展望
TITLE:
摘要: 目的:提高我国国家基本药物抽验管理水平。方法:分析国家基本药物抽验制度出台的背景、实施的难点、推行的经验以及取得的成效,并对今后国家基本药物抽验工作的开展提出了建议。结果与结论:目前我国基本药物抽验工作主要在人员、设备、经费和机制等方面存在困难,实际工作中应主要从“定原则、建系统、抓考核”三方面保障基本药物抽验工作顺利完成。我国已经建立了国家基本药物质量状况的基础数据库,加强了对国家基本药物的监督力度,形成了防范国家基本药物质量安全风险的合力。建议今后在国家基本药物抽验管理工作中兼顾“全覆盖”与“随机性”,发挥其“信息库”和“报警器”作用,并客观看待其“多面性”与“科学性”。
ABSTRACT: OBJECTIVE: To improve the level of sampling test management of national essential medicine in China. METHODS: The sampling test system of national essential medicine was analyzed in terms of background, difficulty, experience and effect, so as to make suggestions for the work in the future. RESULTS & CONCLUSIONS: In view of the difficulties, such as personnel, equipment, funds and mechanism, sampling test of national essential medicine can be finished successfully by “establishing management principle, information system and focusing on evaluation”. The basic database of national essential medicine quality has establisaed successfully so as to establish the quality database of national essential medicine, strengthen the supervision of national essential medicine, form the resultant force to prevent the risk of quality safety. It is suggested to consider about both “full coverage” and “randomness”, play the role of “information database” and “risk warning” and objectively treat its “versatility” and “scientificity” of sampling test management of national essential medicine in the future.
期刊: 2017年第28卷第27期
作者: 陈蕾,朱嘉亮,崔恩学,杨悦
AUTHORS: CHEN Lei,ZHU Jialiang,CUI Enxue,YANG Yue
关键字: 国家基本药物;抽验;管理;分析;展望
KEYWORDS: National essential medicine; Sampling test; Management; Analysis; Prospect
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