文章摘要
王立杰,翟铁伟.ICHQ12对药品上市后变更管理的启示[J].中国药事,2021,35(11):1207-1212
ICHQ12对药品上市后变更管理的启示
Enlightenment of ICH Q12 to the Management of Post-approval CMC Changes
  
DOI:10.16153/j.1002-7777.2021.11.001
中文关键词: ICH Q12  药品上市后变更管理  既定条件  批准后变更管理方案  产品生命周期管理文件
英文关键词: ICH Q12  post-approval change management  established conditions  post-approval change management protocol  product lifecycle management document
基金项目:
作者单位
王立杰 国家药品监督管理局食品药品审核查验中心,北京 100044 
翟铁伟 国家药品监督管理局食品药品审核查验中心,北京 100044 
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中文摘要:
      药品上市后变更管理是药品生命周期管理的重要组成部分,高效的药品变更监管不仅对保证药品质量及安全可及具有重要意义,而且能够有效节约监管机构和企业的资源。2019年,药品生命周期管理的技术和监管考虑(ICH Q12)进入第四阶段,其中提出了一系列变更管理的建议及工具,期望药品上市后变更管理更有效率、更适宜、更有预见性。本文对ICH Q12提出的变更分类、既定条件、批准后变更管理方案等主要变更管理工具进行介绍,分析了药品质量管理体系及知识管理对变更管理的作用,期望对药品上市后变更的研究及管理有所启示。
英文摘要:
      The management of post-approval CMC changes is an important part of pharmaceutical product lifecycle management. Efficient supervision on the changs is not only of great significance to ensure the quality, safety, and availability of drugs, but also can effectively save the resources of regulatory and industry. In 2019, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (ICH Q12) entered the fourth step, in which a series of change management recommendations and tools were put forward, and it is expected that the management of post-approval CMC changes will be more predictable and efficient. This article combines ICH Q12 to introduce change management tools such as categorisation of changes, established conditions, and post-approval change management protocol, and analyzes the effect of pharmaceutical quality system and knowledge management on change management, and hoped that there will be some enlightenment for the research and management of post-approval CMC change management.
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