文章摘要
杨振,李颖,于洋,许四宏,李丽莉,孙彬裕,张孝明.2018年体外诊断试剂国家监督抽验情况分析及对策建议[J].中国药事,2019,33(9):1039-1045
2018年体外诊断试剂国家监督抽验情况分析及对策建议
Analysis and Suggestions for National Supervision and Inspection of in vitro Diagnostic Reagents in 2018
投稿时间:2019-06-28  
DOI:10.16153/j.1002-7777.2019.09.013
中文关键词: 体外诊断试剂  监督抽验  对策建议
英文关键词: in vitro diagnostic reagent  supervision and inspection  countermeasures and suggestions
基金项目:
作者单位E-mail
杨振 中国食品药品检定研究院, 北京 100050 yangzhen@nifdc.org.cn 
李颖 中国食品药品检定研究院, 北京 100050  
于洋 中国食品药品检定研究院, 北京 100050  
许四宏 中国食品药品检定研究院, 北京 100050  
李丽莉 中国食品药品检定研究院, 北京 100050  
孙彬裕 中国食品药品检定研究院, 北京 100050  
张孝明 中国食品药品检定研究院, 北京 100050  
摘要点击次数: 30
全文下载次数: 34
中文摘要:
      目的:对2018年体外诊断试剂国家监督抽验品种进行分析,为国家体外诊断试剂监督执法提供科学依据。方法:通过对体外诊断试剂品种进行梳理、汇总,从产品特点、标准现状、评估基础、法定检验、探索性研究、贯标统计等方面,评估各产品风险点,研究相关对策建议,为加强体外诊断试剂监管提供参考。结果与结论:2018年共完成10个体外诊断试剂品种352批监督抽验任务,合格334批,总合格率为94.9%,整体质量较好。但仍存在个别产品检验不合格,对国家标准和行业标准的理解和执行存在偏差,标签及说明书存在缺陷等问题,监管力度相对不足。建议通过加强贯标工作、合理制订抽验计划以及完善抽验模式等措施,加强体外诊断试剂的监督管理,提高我国体外诊断试剂监督抽验水平。
英文摘要:
      Objective:To analyze the varieties of in vitro diagnostic reagents under the national supervision and inspection in 2018, and lay a scientific basis for the national supervision and enforcement of in vitro diagnostic reagents. Methods:The varieties of in vitro diagnostic reagents were analyzed and summarized. The risk points of each product were evaluated from the following aspects:product characteristics, standard status, evaluation basis, statutory inspection, exploratory research and standard-passing statistics. The related countermeasures and suggestions were provided in order to provide references for strengthening the supervision of in vitro diagnostic reagents. Results and Conclusion:A total of 352 batches of 10 kinds of in vitro diagnostic reagents have been tested for the supervision and inspection in 2018 of which 334 batches were qualified. The total qualified rate was 94.9%, indicating the overall quality was good. However, there still exist some unqualified products, deviations in understanding and implementing national and industry standards, defects in labels and specifications, and relatively insufficient supervision as well. It is suggested that the supervision and management of in vitro diagnostic reagents in China should be improved by taking up such measures as conforming to the standards, making reasonable sampling inspection plans and improving sampling inspection modes.
查看全文   查看/发表评论  下载PDF阅读器
关闭