化学仿制药药学审评常见缺陷和共性问题简介  

Introduction of common deficiencies and issues in CMC review of generic drugs

作　　者：章俊麟 王少戎 王淑华 ZHANG Junlin;WANG Shaorong;WANG Shuhua(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《药学研究》2024年第10期972-978,共7页Journal of Pharmaceutical Research

摘　　要：各国监管机构为提高仿制药审评质量和效率发布了一系列常见缺陷和共性问题,为规范和提升化学仿制药注册申报质量发挥了重要的作用。本文对中美欧等监管机构已发布的与提高申报资料质量相关的指导原则或技术性文件进行归纳总结,对其中与仿制药注册申报中药学技术审评相关的共性问题进行介绍,希望能对促进我国仿制药的高质量发展提供一隅之见。Regulatory agencies in various countries have issued a series of documents on common deficiencies and issues to improve the efficiency of generic drug review,which play an important role in standardizing and improving the quality of filing information.This paper intends to summarize the guidelines or technical documents that have been issued by FDA,EMA and NMPA related to the improvement of the quality of the declaration information,and introduce the common issues related to the pharmacy technical review of the generic drug declarations therein,in the hope that it can provide a glimpse of the high-quality development and reform of China′s generic drugs.

关 键 词：化学仿制药 常见缺陷和共性问题 高质量发展 药品审评 

分 类 号：R95[医药卫生—药学]