摘要
2012年初,国务院下发药品安全"十二五"规划,明确提出将全面提高仿制药质量。本文根据国家食品药品监督管理总局发布的《仿制药质量一致性评价工作方案》,对仿制药质量一致性评价工作中所涉及部门的职责做出了更为详细的解读。
China Food and Drug Administration issued ＂Twelfth Five Year Plan＂ on drug safety, putting forward to improve the quality of generic drugs. This article made a more detailed interpretation on the responsibilities of various departments in quality consistency evaluation of generic drugs.
出处
《中国药事》
CAS
2014年第6期573-575,共3页
Chinese Pharmaceutical Affairs
关键词
仿制药
一致性评价
部门职责
generic drug
quality consistency evaluation
Responsibilities of various departments
