文章摘要
杨会英,赵霞,贺瑞玲,王峰,孙会敏.药包材关联审评审批申报资料技术要求的对比分析[J].中国药事,2018,32(3):310-316
药包材关联审评审批申报资料技术要求的对比分析
Contrastive Analysis of Technical Requirements of Application Documents for Associated Evaluation and Approval of Pharmaceutical Packaging Materials
投稿时间:2016-10-13  
DOI:10.16153/j.1002-7777.2018.03.003
中文关键词: 药包材  关联审评审批  审报资料  技术要求
英文关键词: pharmaceutical packaging materials  associated evaluation and approval  application documents  technical requirements
基金项目:
作者单位E-mail
杨会英 中国食品药品检定研究院, 北京 100050  
赵霞 中国食品药品检定研究院, 北京 100050  
贺瑞玲 中国食品药品检定研究院, 北京 100050  
王峰 中国食品药品检定研究院, 北京 100050  
孙会敏 中国食品药品检定研究院, 北京 100050 sunhm@126.com 
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中文摘要:
      目的:详细解读药包材关联审评审批申报资料的技术要求。方法:通过对比分析药包材注册管理和关联审评审批两种管理模式中申报资料的技术要求,剖析新管理模式的技术特点。结果:关联审评审批管理进一步加强了药品制剂和药包材之间的联系,明确在药包材使用过程中的责任主体,极大地体现了药包材是药品的一个组成部分的重要理念,在研发、生产、质量控制、安全性等方面,对药包材与药品制剂提出了同等要求。结论:关联审评审批管理模式改革是药包材行业健康发展的巨大机遇,必将推动药包材行业水平发生质的飞跃。
英文摘要:
      Objective: To interpret in detail the technical requirements of application documents for associated evaluation and approval of pharmaceutical packaging materials. Methods: The technical requirements of two kinds of management patterns of pharmaceutical packaging materials, registration management and associated evaluation and approval, as well as the technical characteristics of new management mode were analyzed by using the method of contrastive analysis. Results: Associated evaluation and approval management further strengthened the link between drug preparations and pharmaceutical packaging materials, clarified the main responsibility in the process of using pharmaceutical packaging materials, and greatly reflected an important concept that the pharmaceutical packaging material is a part of the drug. Both the pharmaceutical packaging materials and drug preparations have the same requirements in research and development, production, quality control, safety etc. Conclusion: The associated evaluation and approval management mode reform have brought huge opportunities to the healthy development of the pharmaceutical packaging industry and will signifcantly promote the level of pharmaceutical packaging industry.
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