文章摘要
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 between the New and Old Requirements of Organization,Sampling and Acceptance for the Drug Sampling and Testing
投稿时间:2020-01-10  修订日期:2020-05-28
DOI:
中文关键词: 药品抽检  组织  抽样  收检
英文关键词: drug sampling and testing regulation  organization  sampling  acceptance
基金项目:
作者单位邮编
刘文 zhong guo shi pin yao pin jian ding yan jiu yuan 102600
王翀 zhong guo shi pin yao pin jian ding yan jiu yuan 
朱炯* zhong guo shi pin yao pin jian ding yan jiu yuan 102629
胡增峣 guo jia yao pin jian du guan li ju 
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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: Provide a reference for deeply understanding the new regulation for drug sampling and testing to implement it more effectively and reinforce the drug supervision. Methods: 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 propose 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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