【摘要】 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。更多还原

【Abstract】 In order to develop the generic 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 procedures and contents of generic drug quality equivalence assessment to provide reference for evaluation of the consistency.更多还原