浅析仿制药一致性评价程序及内容的相关政策

Analysis the policies about the procedures and contents on generic drug quality equivalence assessment

为了顺利开展仿制药一致性评价工作,国家食品药品监督管理总局出台了大量规范性法规和技术指导原则。本文通过归纳汇总,整理出完整的仿制药一致性评价工作程序和基本内容,为一致性评价工作提供参考。

In order to develop the genetic drug quality equivalence assessment, China Food and Drug Administration （CFDA） introduce a lot of policies and technical guidelines.Based on the induction summary, this review discussed the pro- cedures and contents of generic drug quality equivalence assessment to provide reference for evaluation of the consistency.