| 王胜鹏,朱炯,张弛,王翀.中国与欧盟药品抽查检验监管对比研究[J].中国药事,2020,34(2):146-157 |
| 中国与欧盟药品抽查检验监管对比研究 |
| Comparative Research of Drug Sampling and Testing Administration between China and European Union |
| 投稿时间：2019-09-19 |
| DOI：10.16153/j.1002-7777.2020.02.003 |
| 中文关键词: 药品抽查检验 CAPs抽查检验 组织管理 信息沟通机制 对比分析 |
| 英文关键词: drug sampling and testing CAPs sampling and testing organization and management information communication mechanism compare and analyze |
| 基金项目: |
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| 摘要点击次数: 1115 |
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| 中文摘要: |
| 目的： 对比分析我国药品抽查检验与欧盟CAPs抽查检验监管机制，为制定相关政策提供参考。方法： 检索我国药品抽查检验与欧盟CAPs抽查检验公开信息，汇总分析我国药品抽查检验与欧盟CAPs抽查检验监管机制，就抽查检验目的、组织管理、抽检计划、抽样管理、检验管理和抽查检验结果运用管理等进行对比和分析。结果与结论： 我国药品抽查检验与欧盟CAPs抽查检验整体合格率均较高，体现整体药品质量稳定可控；我国药品抽查检验涉及品种多且覆盖面更广，综合质量分析服务监管和助力企业质量提升效果显著；欧盟CAPs抽查检验中三种管理工具即品种遴选工具、凭单更换机制和信息沟通机制对我国药品监管具有借鉴意义，欧盟CAPs抽查检验工作方向可供我国药品抽查检验借鉴。 |
| 英文摘要: |
| Objective: To compare and analyze the drug sampling and testing administration of China and centrally authorized products (CAPs) sampling and testing administration of European Union (EU) so as to provide references for formulating relevant policies. Methods: The published information of drug sampling and testing administration of China and CAPs sampling and testing administration of EU was retrieved and analyzed. The aim of sampling and testing, organization and management, sampling and testing plan, sampling management, testing management, application and management of sampling and testing results were compared in order to provide references for the pharmaceutical administration of China. Results and Conclusion: The overall pass rates of drug sampling and testing administration in China and CAPs sampling and testing administration of EU were high, reflecting the stable and controllable quality of the pharmaceuticals. The drug sampling and testing administration in China involves more varieties and wider coverage, comprehensive quality analysis had remarkable effect on serving pharmaceutical administration and improving the quality of enterprises. Three tools used in CAPs sampling and testing administration of EU, such as variety selection tool, sampling voucher replacement system and information communication mechanism, had reference significance for pharmaceutical administration of China. Furthermore, the future development direction of CAPs sampling and testing of EU could provide references for the drug sampling and testing administration in China. |
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