摘要
国家药品监督管理局颁布的《药品质量抽查检验管理办法》,对药品抽检提出了新的要求,体现了"四个最严"精神,其中抽样、检验和复验等要求体现"最严谨的标准";重点抽检品种、抽样时的监督检查、不符合规定药品及其他风险问题的处理体现"最严格的监管";对逃避抽检、制售假劣药品单位的核查处置体现"最严厉的处罚";监管部门的职权范围和抽样单位、检验机构的行为规范体现"最严肃的问责",建议相关单位注重《药品质量抽查检验管理办法》的落实,转变抽检思路,创新工作方法,打破监管孤岛,更好地发挥药品抽检的作用。
The Regulations on Sampling and Testing of Drug Quality issued by National Medical Product Administration put forward new requirements for drug sampling and testing,embodying the four strictest requirement.The strictest standard was shown in the sampling,testing and re-testing;the strictest supervision was in the requirements for the key sampling drugs,supervision before sampling,and the treatment of non-conforming drugs and other risks;the strictest punishment was in the inspection and disposal of those who violated the rules of sampling and testing,and those who manufactured and sold counterfeit and inferior drugs;the strictest accountability was in the responsibilities of the supervision departments,and conduct codes of sampling and testing institutes.We should pay attention to the implementation of the Regulations on Sampling and Testing of Drug Quality,comprehensively investigate quality and safety risks,make full use of"smart supervision",and jointly punish the manufacturers and sellers of counterfeit and substandard drugs.
作者
刘文
朱炯
胡骏
王翀
胡增峣
LIU Wen;ZHU Jiong;HU Jun;WANG Chong;HU Zeng-yao(National Institute for Food and Drug Control,Beijing 102629;Shanghai Institute for Food and Drug Safety,Shanghai 200233;National Medical Product Administration,Beijing 100037)
出处
《中南药学》
CAS
2020年第10期1776-1780,共5页
Central South Pharmacy
基金
国家药品抽检买样机制研究项目(No.2018-2563)。
关键词
药品抽检
标准
监管
处罚
问责
建议
drug sampling and testing
standard
supervision
punishment
accountability
suggestion
