美国生物材料入境监管架构的启示

发布时间：2018-04-26 11:45

本文选题：生物材料 + 入境　；参考：《南京医科大学学报(社会科学版)》2015年06期

【摘要】：美国生物材料入境监管架构对我国生物材料入境监管有重要借鉴意义。其借鉴的重点和难点可从四个方面进行探讨:进出口生物医药企业必须承担诚信管理的义务;进出口生物医药企业必须是生物安全管理的第一责任人;必须重视国际上成熟法规和技术的学习和引入,提高国内出入境特殊物品相关法规的权威性和可操作性;生物材料入境监管工作必须重视所需的基础研究投入。
[Abstract]:American biomaterial entry regulatory framework is of great significance for China's biomaterial entry regulation. The key points and difficulties can be discussed from four aspects: import and export biopharmaceutical enterprises must bear the duty of good faith management, import and export biomedical enterprises must be the first responsible person in biosafety management; Attention must be paid to the study and introduction of mature laws and techniques in the world, to improve the authority and maneuverability of the relevant laws and regulations on entry and exit of special articles in China, and to attach importance to the basic research input required for the supervision of entry into the country of biological materials.
【作者单位】：苏州出入境检验检疫局卫生监管处;江苏出入境检验检疫局卫生监管处;上海药明康德新药开发有限公司商业发展部;
【基金】：江苏检验检疫局立项课题“出入境生物制品病毒安全性检测平台”(2015KJ37)
【分类号】：R318.08;F203

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