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中国生物工程杂志

CHINA BIOTECHNOLOGY
中国生物工程杂志  2011, Vol. 31 Issue (5): 138-141    
生物技术管理     
兽用疫苗管理与控制的国际标准
卢国栋, 张克山, 刘永杰, 尚佑军, 郭建宏, 郑海学, 田宏, 刘湘涛
中国农业科学院兰州兽医研究所 家畜疫病病原生物学国家重点实验室 农业部畜禽病毒学重点开放实验室 国家口蹄疫参考实验室 兰州 730046
International Standard of Regulation and Control for Veterinary Vaccine
LU Guo-dong, ZHANG Ke-shan, LIU Yong-jie, SHANG You-jun, GUO Jian-hong, ZHENG Hai-xue, TIAN Hong, LIU Xiang-tao
Lanzhou Veterinary Research Institute of Chinese Academy of Agricultural Sciences, State Key Laboratory of Veterinary Etiological Biology, National Foot-and-Mouth Disease Reference Laboratory, Key Laboratory of Animal Virology of Ministry of Agriculture, Gansu 730046,China
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摘要:

兽用疫苗是兽医医学产品,需接受像医学产品相同或相似的管理和控制标准,这意味着动物疫苗必须满足复杂的要求,保障产品在预期使用条件下的质量、安全性和免疫效力。在动物医药领域中,欧盟和美国的动物疫苗管理和控制体系发展早,制度完整,为其他国家和地区建立良好的动物疫苗管理与控制标准提供了有价值的参考信息。另外,统一各个国家和地区的兽用疫苗管理与控制标准是加速实现全球兽用疫苗自由、快速国际贸易的重要途径。

关键词: 兽用疫苗管理与控制标准欧盟与美国标准国际统一化    
Abstract:

Veterinary vaccine is veterinary medical product, so it needs the same or similar regulation and control standards as medical product. And animal vaccine must meet the complex requirements, ensuring the quality, safety and immune efficacy. In this field, biological products have more problems, because biological products are basic with natural existing organisms, so they are easier to be imitated and not protected by the patent law. In the animal medicine field, the animal vaccine regulation and control system of the European Union and the United States develops early, and by now it has almost been integrity. It can offer valuable reference informations for other countries and regions to establish good animal vaccine regulations and control standards. In addition, that unifying all countries and areas' veterinary vaccine regulation and control standard is a way to accelerate making free, rapid global veterinary vaccine international trade.

Key words: Veterinary vaccine    Regulation and control standards    Eu and US standards    International unification
收稿日期: 2011-01-20 出版日期: 2011-05-27
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引用本文:

卢国栋, 张克山, 刘永杰, 尚佑军, 郭建宏, 郑海学, 田宏, 刘湘涛. 兽用疫苗管理与控制的国际标准[J]. 中国生物工程杂志, 2011, 31(5): 138-141.

LU Guo-dong, ZHANG Ke-shan, LIU Yong-jie, SHANG You-jun, GUO Jian-hong, ZHENG Hai-xue, TIAN Hong, LIU Xiang-tao. International Standard of Regulation and Control for Veterinary Vaccine. China Biotechnology, 2011, 31(5): 138-141.

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https://manu60.magtech.com.cn/biotech/CN/        https://manu60.magtech.com.cn/biotech/CN/Y2011/V31/I5/138


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[1] 卢国栋 张克山 刘永杰 尚佑军 郭建宏 郑海学 田宏 刘湘涛. 兽用疫苗管理与控制的国际标准[J]. 中国生物工程杂志, 2011, 31(05): 0-0.