我国兽用生物制品与人用生物制品国家管理体系的差异  

The Differences between the National Control Systems of Veterinary Biological Products and Human Biological Products in China

作　　者：赵炜 高洁 刘伟洁 白洪旭 苏佳 陈晓春[1] 薛青红[1] ZHAO Wei;GAO Jie;LIU Wei-jie;BAI Hong-xu;SU Jia;CHEN Xiao-chun;XUE Qing-hong(China Institute of Veterinary Drug Control,Beijing 100081,China;Beijing Zhonghai Biotech Co.,Ltd.,Beijing 100081,China)

机构地区：[1]中国兽医药品监察所(农业农村部兽药评审中心),北京100081 [2]北京中海生物科技有限公司,北京100081

出　　处：《中国兽药杂志》2024年第8期52-57,共6页Chinese Journal of Veterinary Drug

摘　　要：近年来,随着我国畜牧养殖业的迅速发展、动物源性食品安全和兽医公共卫生安全受到前所未有的重视,我国兽用生物制品产业也取得了长足的进步。兽用生物制品和人用生物制品由于在起始材料、生产工艺和生物学用途上的诸多相似性,包括我国在内的世界上许多国家均采用共同或相似的管理体系。从国家职能机构、法律法规和管理方式等方面宏观的比较了我国兽用生物制品和人用生物制品国家管理体系的异同,分析了这些异同点产生的原因并简要指出了我国兽用生物制品管理的发展方向。In recent years,with the rapid development of China’s animal husbandry and the increasing attention to the safety of animal-origin food and veterinary public health,the veterinary biological product industry in China has made remarkable progress.Human-use biological products and veterinary biological products share many similarities in terms of starting materials,production processes,and biological applications.Many countries,including China,adopt common or similar control systems.The control systems of human biological products and veterinary biological products in China in terms of national functional institutions,laws and regulations,and management methods were macroscopically compares.The reasons for these similarities and differences were analyzed,and the development direction of the management of veterinary biological products in China was briefly pointed out.

关 键 词：生物制品 职能机构 法律法规 管理体系 差异 

分 类 号：S851.66[农业科学—预防兽医学]