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美国ANDA申报参照药品行业指南草案介绍

马玲云,萧红街,关皓月,孙慧姝,许鸣镝   

  1. 中国食品药品检定研究院,中国食品药品检定研究院,中国食品药品检定研究院,广东省食品药品监督管理局审评认证中心,中国食品药品检定研究院
  • 收稿日期:2018-03-28 修回日期:2018-03-28 出版日期:2018-04-25 发布日期:2018-04-25
  • 基金资助:
    国家“重大新药创制”科技重大专项资助项目(2017ZX09101001)

Introduction of The Guidance for Industry of Referencing Approved Drug Products in ANDA Submissions

MA Ling-yun,,, and   

  1. National Institutes for Food and Drug Control,National Institutes for Food and Drug Control,National Institutes for Food and Drug Control,Center For Certification And Evaluation,Guangdong Food And Drug Administration,
  • Received:2018-03-28 Revised:2018-03-28 Online:2018-04-25 Published:2018-04-25
  • Supported by:
    National Major Scientific and Technological Special Project for “Significant New Drugs Development”

摘要: 随着药品审评审批制度改革的不断深入,仿制药一致性评价工作已全面开展,其中参比制剂选择与确定是制约一致性评价工作进展的因素之一,本文通过翻译转化,详细地介绍了美国ANDA申报参照药品行业指南草案,以期为我国仿制药一致性评价工作中参比制剂遴选提供参考依据。

Abstract: With the continuous deepening the reform of the review & approval System for drugs, the evaluation of generic drug conformity has been carried out in an all-round way. Among them, the selection and determination of reference Listed drug are one of the factors restricting the progress of conformity assessment. This paper Introduces of The Guidance for Industry of Referencing Approved Drug Products in ANDA Submissions in detail through translation and transformation, which provides reference for the selection of reference Listed drug in the evaluation of the conformity of generic drugs in our country.