摘要
为提升已上市的仿制药质量水平,淘汰内在质量和临床疗效达不到要求的品种,国家食品药品监督总局全面启动了仿制药一致性评价工作。在调查我国仿制药现状的基础上,本文分析了当前仿制药一致性评价工作面临的一些制约因素,并最终有针对性地提出了解决对策,供业内及监管部门参考。
In order to improve the quality of marketed generic drugs and eliminate those un- qualified in either intrinsic quality or clinical effi- cacy, the program of “quality consistency evalu- ation for generics” has been started by the China Food and Drug Administration. Based on the in- vestigation into the current status of domestic generics, we explored the factors restricting the evaluation of quality consistency for generic drugs, and eventually put forward particular countermeasures for the reference of industry and supervision department.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2015年第1期118-120,100,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
关键词
仿制药
一致性评价
现状
对策
generic drugs
quality consisten-cy evaluation
current status
countermeasures
