化学仿制药新申报资料要求简介

Brief introduction to the new requirements of submission documents for chemical generic drugs

本文对国家食品药品监督管理总局新发布的"化学药品新注册分类申报资料要求(试行)"进行了简要介绍与讨论。重点介绍了仿制药新的申报资料要求的起草背景与自评估报告,以及生产、起始原料、杂质谱、质量控制与稳定性等部分的主要变化点、在化学仿制药的研发与申报资料中如何理解与把握这些新的要求。

Here,the CFDA＇s new requirements of the submission documents for chemical generic drugs（ trial） were briefly introduced and discussed. Mainly the background of this new requirement and the selfevaluation report were introduced. The major changes in the sections of manufacture,starting materials,impurity profile,quality control and stability were also introduced. It was discussed how to comprehend and execute these new requirements when developing and preparing the submission documents of the chemical generic drugs.