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兽用生物制品批准文号审查要点及问题解析
谭克龙,宫爱艳,吴涛
0
(中国兽医药品监察所)
摘要:
介绍了我国兽药产品批准文号申报与审查工作总体情况及,并针对兽用生物制品批准文号申报退回率较高的情况,着重阐述了申报资料技术审查要点,分析了兽药产品批准文号申报工作中的常见问题及产生原因解析,以期为企业申报工作提供参考。
关键词:  兽药产品批准文号  技术审查  常见问题
DOI:
投稿时间:2019-12-03修订日期:2019-12-24
基金项目:
Common Problems and Suggestions on China Veterinary Drug Products License in the Approval Procedure
(China Institute of Veterinary Drug Control)
Abstract:
This paper introduced the overall situation of China veterinary drug products license(VDPL) and the key point of application materials, analyzed the common problems and reasons of the approval number of veterinary drugs in China products .Some suggestions were also put forward for enterprises to reference .
Key words:  veterinary drug products license  key points  common problems

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