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    2019年仿制药一致性评价申报资料常见问题案例解析

    摘要

    不少仿制药一致性评价申报者研发与撰写经验不足,对官方申报要求理解不到位,导致申报资料不尽如人意,资料有发补甚至退审的风险。本文以申报资料中常见问题为切入点,解读官方发布的申报要求,并根据笔者多年研发与审评经验给出一些参考建议,为申报者规范撰写仿制药一致性评价申报资料提供参考建议,以供申报者不断改进、完善申报资料。

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    Abstract

    The objective was to provide reference and suggestion for applicants to standardize the application materials for the consistency evaluation of generic drugs. Starting with common problems in the application materials,this report interpreted the official requirements,and gave some suggestions based on the author’s years of experience in generic drug development and review. Due to the applicants’ lack of R&D and writing experience,the official requirements were not well understood,which led to the unsatisfactory application of many generic drugs for consistency evaluation. There was a risk that the materials would need to be supplemented or even withdrawn. Therefore,applicants should keep learning,sum up experience,and continuously improve and perfect the application materials.

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    作者简介
    余立:余立,北京市药品检验所原所长助理,主任药师。
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