摘要
药品质量抽查检验是上市后药品监管的重要手段之一,本文旨在通过对新修订《药品质量抽查检验管理办法》的分析和探讨,提出可行的应对举措和建议,推动药品抽检管理模式的创新。介绍新修订的《药品质量抽查检验管理办法》的基本背景及总体思路,结合药品抽检工作中的实际情况,对主要修订要点及新变化条款进行分析和梳理,就如何做好新时期的国家药品抽检工作提出思路和建议。各级药品监管机构应该转变观念,完善现有抽检工作模式、探索新的“智慧监管”模式,以进一步落实新修订的《药品质量抽查检验管理办法》中的监管要求。
Drug quality sampling and testing is one of the important means of drug supervision after marketing.The purpose of this article is to analyze and discuss the newly revised“regulations for drug quality sampling and testing”to propose feasible countermeasures and suggestions to promote the innovation of the management mode of drug sampling inspection.The basic background and general idea of the newly revised“regulations for drug quality sampling and testing”were introduced,and the main points of amendments and the new changes according to the actual problems in the national drug sampling inspection were analyzed and sorted out.Suggestions and countermeasures for national drug quality sampling and testing during this period were proposed.Drug regulatory agencies at all levels should change their minds,improve existing sampling inspection work modes,and explore new“smart supervision”modes to further implement the regulatory requirements in the newly revised“regulations for drug quality sampling and testing”.
作者
朱嘉亮
王翀
胡骏
李哲媛
朱炯
杨悦
ZHU Jia-liang;WANG Chong;HU Jun;LI Zhe-yuan;ZHU Jiong;YANG Yue(National Institutes for Food and Drug Control,Beijing 102629,China;Shanghai Institute for Food and Drug Safety,Shanghai 200233,China;Yunnan Institute for Food and Drug Control,Kunming 650106,China;Institute of Drug Regulatory Sciences,Shenyang Pharmaceutical University,Shenyang 110016,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第18期2055-2059,共5页
Chinese Journal of New Drugs
关键词
药品
抽查检验
工作模式
drug
quality sampling and testing
working mode
