文章摘要
刘文,王翀,朱炯,胡增峣.药品质量抽查检验的组织、抽样和收检要求新旧对比研究[J].中国药事,2020,34(6):619-624
药品质量抽查检验的组织、抽样和收检要求新旧对比研究
A Comparative Research on the New and Old Requirements of Organization, Sampling and Acceptance for Drug Sampling and Testing
投稿时间:2020-01-10  
DOI:10.16153/j.1002-7777.2020.06.001
中文关键词: 药品抽检  组织  抽样  收检
英文关键词: drug sampling and testing  organization  sampling  acceptance
基金项目:
作者单位E-mail
刘文 中国食品药品检定研究院, 北京 102629  
王翀 中国食品药品检定研究院, 北京 102629  
朱炯 中国食品药品检定研究院, 北京 102629 zhujiong@nifdc.org.cn 
胡增峣 国家药品监督管理局, 北京 100037  
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中文摘要:
      目的: 加深相关人员对《药品质量抽查检验管理办法》的理解,以有效地落实抽检规定,加强药品监管。方法: 对比研究《药品质量抽查检验管理办法》和《药品质量抽查检验管理规定》中组织、抽样和收检要求,分析新增和修订内容的必要性与意义,提出实施建议。结果与结论: 《药品质量抽查检验管理办法》基于药品监管需要,相对于《药品质量抽查检验管理规定》新增和修订的组织、抽样和收检相关内容,对加强抽检管理,提高抽样、收检工作效能,进而打击假冒伪劣药品,防控潜在质量安全隐患具有重要意义。
英文摘要:
      Objective: To provide references for deeply understanding the new regulation for drug sampling and testing to implement it more effectively and reinforce the drug supervision. Methods: To compare the organization, sampling and acceptance requirements of the new and old regulations, which were issued in August 2019 and July 2006, respectively, analyze the necessity and significance of their new and revised contents, and put forward the suggestions for implementation. Results and Conclusion: The new and revised contents of organization, sampling and acceptance have great value to reinforce the management of drug sampling and testing and improve the efficiency of sampling and acceptance, and then fight against the counterfeit and inferior drugs and the potential risk.
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