Standard No.:	DB32/T 4718-2024
English Name:	Specification of quality comparison for post-approval changes of chemical drugs
Chinese Name:	化学药品上市后变更质量对比规范
Chinese Classification:	C00    Standardization and quality management
Professional Classification:	DB    Provincial Standard
Source Content Issued by:	Jiangsu Adminstration of Market Regulation
Issued on:	2024-03-25
Implemented on:	2024-4-25
Status:	valid
Target Language:	English
File Format:	PDF

本文件规定了化学药品上市后变更质量对比研究（溶出曲线、杂质i普、关键理化指标等）的要求。
本文件适用于化学药品上市后部分微小变更、中等及以上变更类别下开展的质量对比研究（溶出曲线、杂质谱、关键理化指标等）活动。