| 仿制药一致性评价现状调查及对策 |
| |
| 引用本文： | 余珊珊,张正付,李正奇. 仿制药一致性评价现状调查及对策[J]. 金属学报, 2015, 20(1): 118-120 |
| |
| 作者姓名： | 余珊珊 张正付 李正奇 |
| |
| 作者单位： | 1.安徽省食品药品审评认证中心,合肥 230052,安徽;2.国家食品药品监督管理总局药品认证管理中心,北京 100061 |
| |
| 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。
|
| 关 键 词： | 仿制药 一致性评价 现状 对策 |
| 收稿时间： | 2014-04-09 |
| 修稿时间： | 2014-07-17 |
Investigation and countermeasures to the current status of the generics quality consistency evaluation |
| |
| YU Shan-shan,ZHANG Zheng-fu,LI Zheng-qi. Investigation and countermeasures to the current status of the generics quality consistency evaluation[J]. Acta Metallurgica Sinica, 2015, 20(1): 118-120 |
| |
| Authors: | YU Shan-shan ZHANG Zheng-fu LI Zheng-qi |
| |
| Affiliation: | 1.Anhui Center for Food and Drug Evaluation and Certification, Hefei 230052, Anhui, China;2.Center for Certification of Drug, China Food and Drug Administration, Beijing 100061, China |
| |
| Abstract: | In order to improve the quality of marketed generic drugs and eliminate those unqualified in either intrinsic quality or clinical efficacy, the program of “quality consistency evaluation for generics” has been started by the China Food and Drug Administration. Based on the investigation 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. |
| |
| Keywords: | generic drugs quality consistency evaluation current status countermeasures |
|
| 点击此处可从《金属学报》浏览原始摘要信息 |
|
点击此处可从《金属学报》下载全文 |
|
