2022年国家药品抽检质量状况分析研究  

Analytical Study of the Quality Status of National Drug Sampling and Testing in 2022

作　　者：朱嘉亮[1] 孙婷 陈碧莲 荣娜娜 王翀[1] 胡增峣 ZHU Jialiang;SUN Ting;Chen Bilian;RONG Nana;WANG Chong;HU Zengyao(National Institutes for Food and Drug Control,Beijing 100050,China;Institute of Medical Engineering and Translational Medicine,Tianjin University,Tianjin 300072,China;Hebei Institute of drug and Medical Device Inspection,Shijiazhuang 050200,China;Zhejiang Institute for Food and Drug Inspection,Hangzhou 310052,China;Yunnan Institute for Food and Drug Inspection,Kunming 650106,China;National Medical Products Administration,Beijing 100037,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]天津大学医学工程与转化医学研究院,天津300072 [3]河北省药品医疗器械检验研究院,石家庄050200 [4]浙江省食品药品检验研究院,杭州310052 [5]云南省食品药品监督检验研究院,昆明650106 [6]国家药品监督管理局,北京100037

出　　处：《医药导报》2024年第10期1706-1710,I0001,共6页Herald of Medicine

基　　金：河北省药品监督管理局科技计划项目(2022ZC1029)。

摘　　要：目的了解和掌握2022年国家药品抽检质量状况及可能存在的药品质量风险。方法以问题为导向,以风险防控为目标,采取“分散抽样、集中检验、探索研究、综合评价”的抽检模式。回顾国家药品抽检历年检验情况,针对2022年国家药品抽检的整体质量情况进行总体分析,重点对发现的主要质量问题及风险进行挖掘和分析。结果2022年抽检平均合格率为99.4%。中国上市后药品质量总体安全形势平稳可控,药品质量处于较高水平。结论通过开展与药品安全性、真实性、有效性等方面的探索性研究,国家抽检在全面评价药品质量状况、提升品种质量控制水平及行业标准、强化质量安全监管、打击掺杂掺假等违法违规行为、警示公众用药安全等方面发挥重要作用。Objective To understand and assess the quality status of national drug sampling inspection in 2022 and the possible risks of drug quality.Methods With the aim of identifying issues and preventing risks,a sampling model of"dispersed sampling,centralized inspection,exploratory research,and comprehensive evaluation"was used to review the historical inspection data of national drug sampling.The overall quality and potential risks of national drug sampling in 2022 were analyzed,with a focus on identifying and examining the main quality problems and risks.Results The average pass rate of the sampling inspection in 2022 was 99.4%.The overall safety situation of China's post-marketing drug quality is stable and manageable,indicating that the drug quality is at a high level.Conclusions By carrying out exploratory studies related to drug safety,authenticity,and efficacy,national sampling plays an important role in comprehensively evaluating the quality status of drugs.It aids in improving the quality control level of drug varieties and industry standards,strengthening quality and safety supervision,combating illegal practices such as adulteration and falsification,and providing public warnings about drug safety.

关 键 词：国家药品抽检 质量状况 药品质量风险 

分 类 号：R917[医药卫生—药物分析学]