| 王胜鹏,王翀,张弛,朱炯.药品质量抽查检验管理办法修订探讨[J].中国药事,2020,34(5):542-548 |
| 药品质量抽查检验管理办法修订探讨 |
| On the Amendment of Administrative Measures for Drug Quality Sampling and Testing |
| 投稿时间：2019-08-31 |
| DOI：10.16153/j.1002-7777.2020.05.007 |
| 中文关键词: 药品质量抽查检验管理办法 药品管理法 上市许可持有人 信用管理 对比分析 |
| 英文关键词: drug quality sampling and testing the Drug Administration Law marketing authorization holder credit management contrastive analysis |
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| 摘要点击次数: 1343 |
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| 中文摘要: |
| 目的： 通过探讨药品质量抽查检验管理办法（2019）与药品质量抽查检验管理规定（2016）的差异，为新文件在实际工作中的应用提供参考，进一步促进药品质量抽查检验工作的发展。方法： 从监管理念、技术要求方面，对比分析新旧药品质量抽查检验管理办法的差异和变化。结合新修订《药品管理法》的实施，探讨药品质量抽查检验组织管理，为我国药品监管提供参考。结果与结论： 新《药品质量抽查检验管理办法》调整了药品抽查检验的组织管理、抽样、检验和复检工作要求，完善了计划制定、探索性研究及风险信息技术分析和综合研判机制，加强了信息公开和监督管理工作。《药品质量抽查检验管理办法》对药品抽查检验工作起到了重要的规范和指导作用，也为提高药品抽查检验工作质量和效率提供了有力保障。我国药品抽查检验以落实新修订《药品管理法》中的监管要求为切入点，进一步强化药品监管。 |
| 英文摘要: |
| Objective: The differences between the latest amendment (2019) and former version (2016) of the administrative measures for drug quality sampling and testing were probed to provide references for applying the new files, and to further promote the development of the drug quality sampling and testing. Methods: Referring to the relevant administration concepts and technical requirements, differences between two versions of administrative measures for drug sampling and testing were compared and analyzed. Combined with the implementation of the newly revised Drug Administration Law, the organization and management of drug sampling and testing were explored to provide references for the drug administration of China. Results and Conclusions: The new administrative measures for drug quality sampling and testing adjusted the organization, sampling, testing and re-test requirements, improved the management of planning, the mechanism of exploratory research, the technology analysis, comprehensive research and judgment of risk information, strengthened regulations on information publicity, supervision and management. The new administrative measures for drug quality sampling and testing play an important role in norm and guidance for the management on drug sampling and testing, and provide a strong guarantee for the promotion of quality and efficiency of drug sampling and testing work. The drug quality sampling and testing take the implementation of the regulatory requirements in the newly revised Drug Administration Law as the starting point, to further strengthen the drug administration. |
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