监管认定所需假劣药检验模式的建立  

Establishement of Regulation Identification-Oriented Testing Mode of Falsified and Substandard Drugs

作　　者：黄宝斌 洪建文[2] 倪维芳 张炜敏 薛晶[1] 黄清泉[1] HUANG Baobin;HONG Jianwen;NI Weifang;ZHANG Weimin;XUE Jing;HUANG Qingquan(National Institutes for Food and Drug Control,Beijing,China 102629;Guangdong Institute for Drug Control,Guangzhou,Guangdong,China 510663;Zhejiang Institute for Food and Drug Control,Hangzhou,Zhejiang,China 310052)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]广东省药品检验所,广东广州510663 [3]浙江省食品药品检验研究院,浙江杭州310052

出　　处：《中国药业》2023年第10期17-20,共4页China Pharmaceuticals

基　　金：中国食品药品检定研究院中青年发展研究基金课题[2020G1]。

摘　　要：目的建立监管认定所需假药、劣药(简称假劣药)的检验模式。方法分析相关法律和政策中假劣药的定义及认定要求的调整变化,结合假劣药检验工作实践,建立新形势下的假劣药认定工作模式,并提出有效运行的基本条件。结果建立了以监管认定为核心的假劣药检验工作模式,该模式有效运行的基本条件包括,以涉案产品是否为药品作为认定工作的前提,检验需求、检验事权划分明确,检验要素规范。结论该模式能合理利用检验资源,可提高认定的质量与效率,实现监管执法与刑事司法的有效衔接。Objective To establish a regulation identification-oriented testing mode of falsified and substandard drugs.Methods The updates on the definition and identification of falsified and substandard drugs in relevant laws and policies were analyzed,a mode of falsified and substandard drug identification under the new situation was established based on the practice of falsified and substandard drug testing,and the basic conditions of the effective operation for this mode were proposed.Results A mode of falsified and substandard drug testing with the regulation identification as the core was established.The basic conditions of the effective operation for this mode were as follows:the premise for identification was whether the involved product was a drug,the testing needs and division of testing powers were clear,and the testing elements were standardized.Conclusion This mode can make reasonable use of testing resources,improve the quality and efficiency of identification,and realize the effective connection of regulatory,law enforcement and criminal justice.

关 键 词：假药 劣药 监管认定 检验模式 运行条件 药品监管 

分 类 号：R95[医药卫生—药学]