• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2021, Vol. 38 ›› Issue (6): 488-492.

• 监管科学与应用 • 上一篇    下一篇

中美原料药、药用辅料和药包材的注册管理对比研究

 王佳,袁利佳,张宁*   

  1. 国家药品监督管理局药品审评中心,北京 100022
  • 收稿日期:2021-10-21 修回日期:2021-11-12 出版日期:2021-12-28 发布日期:2021-12-28

Comparative on the Registration Management of Active Pharmaceutical Ingredient, Pharmaceutical Excipient and Pharmaceutical Packaging Material between China and the United States

  WANG jia,YUAN li-jia,ZHANG ning*   

  1. Center for Drug Evaluation, National Medicine Products Administration, Beijing 100022, China
  • Received:2021-10-21 Revised:2021-11-12 Online:2021-12-28 Published:2021-12-28
  • Contact: zhang 无ning E-mail:zhangning@cde.org.cn

摘要: 对中美两国原料药、药用辅料和药包材(以下简称“原辅包”)注册管理工作进行阐述和比较,包括政策和指导文件、产品适用范围和要求、登记(提交)和审查、变更和年报及关联审评程序等方面对比分析,旨在对我国原辅包注册管理工作的改进提供借鉴。

关键词: font-size:medium, ">原辅包;药品主文件;登记;关联审评

Abstract: In order to put forward some suggestions on registration management in China,this paper made an systematically analysis & introduction on registration management of active pharmaceutical ingredient, pharmaceutical excipient and pharmaceutical packaging materials between China and the United States.The introduction includes relevant policies and guidance,application scope and corresponding requirement of product, registration (submission), review, change, annual reports and related evaluation procedures.
  

Key words: Packaging materials in direct contact with drugs, Drug Master File, Registration, Bundling review

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