对规范国家药品评价抽验不合格报告书传递工作的几点建议  

Suggestion on Criterion of Unqualified Reports Transmission in Drug Evaluation Process

作　　者：黄志禄[1] 郭志鑫[1] 丛佳[1] 朱炯[1] 冯磊[1] 张欣涛[1] 李延敏[2] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]沈阳药科大学工商管理学院

出　　处：《中国药事》2011年第10期998-999,共2页Chinese Pharmaceutical Affairs

摘　　要：目的为进一步完善我国药品评价抽验模式提供参考。方法通过阐述国家药品评价抽验现行不合格报告书传递工作的法律依据、背景及程序,分析如何进一步完善该项工作。结果归纳出当前国家药品评价抽验模式中不合格报告书传递工作的重要性及存在的问题,提出完善的措施。结论不合格报告书传递工作的规范化将进一步提高抽验效能,促进国家药品质量公告的科学、规范。Objective To further improve the sampling mode of drug evaluation in China.Methods To state legislative basis,background and procedure of unqualified reports transmission in current domestic drug evaluation process and to analyze the measures in order to improve its process.Results To set forth the importance and present problem of unqualified reports transmission in current modes of sampling evaluation and to put forward the measures.Conclusion To strengthen the efficiency of unqualified reports transmission in drug evaluation process and to promote the science and standardization of national drug quality announcement.

关 键 词：药品评价抽验 不合格报告书 传递 

分 类 号：R95[医药卫生—药学]