仿制药一致性评价品种的美国简略新药申请申报策略

Abbreviated New Drug Application Filing Strategy for Generic Drugs Required to Perform Quality Consistency Evaluation in China

文章从产品的开发以及申报资料的撰写等方面探究仿制药一致性评价品种的美国简略新药申请申报策略,为中国仿制药国际化战略提供参考。

This article briefly introduced the FDA Abbreviated New Drug Application （ANDA） filing Strategy for generic drugs required to perforua Quality Consistency Evaluation in China from the aspects of drug product development and documentation filing, so as to provide reference for the internationalization strategy for China＇s generic drugs.