| 仿制药质量一致性评价各部门职责 |
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| 引用本文： | 许鸣镝,牛剑钊,张启明. 仿制药质量一致性评价各部门职责[J]. 中国药事, 2014, 0(6): 573-575 |
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| 作者姓名： | 许鸣镝 牛剑钊 张启明 |
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| 作者单位： | 中国食品药品检定研究院,北京100050 |
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| 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。
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| 关 键 词： | 仿制药 一致性评价 部门职责 |
The Responsibilities of Various Departments in Quality Consistency Evaluation of Generic Drugs |
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| Xu Mingdi,Niu Jianzhao,Zhang Qiming. The Responsibilities of Various Departments in Quality Consistency Evaluation of Generic Drugs[J]. Chinese Pharmaceutical Affairs, 2014, 0(6): 573-575 |
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| Authors: | Xu Mingdi Niu Jianzhao Zhang Qiming |
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| Affiliation: | (National Institutes for Food and Drug Control, Beijing 100050) |
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| Abstract: | 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. |
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| Keywords: | generic drug quality consistency evaluation Responsibilities of various departments |
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