摘 要 在开展仿制药一致性评价中，首先需准确确定参比制剂，并按照国家药品监督管理局的要求进行申请。本文介绍快速查询参比制剂的方法、常用网站以及在确定参比制剂时应注意的一些事项。

    关键词 参比制剂 仿制药 一致性评价

    中图分类号：R926； R951 文献标志码：C 文章编号：1006-1533(2020)13-0015-04

    Methods and precautions for quick confirmation of reference preparation in consistency evaluation for generics

    LI Shuai*， CHEN Guiliang

    (Shanghai Center for Drug Evaluation and Inspection， Shanghai 201203， China)

    ABSTRACT In the consistency evaluation of generics， it is necessary to accurately confirm the reference preparation and to apply according to the requirements of the National Medical Products Administration. This article introduces the method for quick inquiry of reference preparation ......