美国FDA对相关特殊物品的进出口监管及海关通关流程概述  

Overview of the Import and Export Supervision of the US FDA and Customs Clearance Process for Related Special Articles

作　　者：符丽媛 孙涛 翁琦 盛祝毅 姜志凤 吴海磊 FU Liyuan;SUN Tao;WENG Yunqi;SHENG Zhuyi;JIANG Zhifeng;WU Hailei(Suzhou industrial park Customs,Suzhou Jiangsu 215021,China;Nanjing Customs,Nanjing Jiangsu 210001,China;Animal,Plant and Food Inspection Center of Nanjing Customs District,Nanjing Jiangsu 211106,China;Comprehensive Technical Service Center of Yangzhou Customs,Yangzhou Jiangsu 225012,China)

机构地区：[1]苏州工业园区海关,江苏苏州215021 [2]南京海关,江苏南京210001 [3]南京海关动植物与食品检测中心,江苏南京211106 [4]扬州海关综合技术服务中心,江苏扬州225012

出　　处：《口岸非传统安全学刊》2024年第1期11-14,31,共5页

基　　金：南京海关科研项目(2023KJ16)。

摘　　要：本文针对我国药械相关特殊物品监管体系有待完善这一问题,采用对美国政府官方网站的原始材料进行翻译整理研究的方法,系统阐述美国食品药品监督管理局的组织架构、监管职能、对特殊物品的进口验证以及出口认证制度,对中美药监及海关对于进口特殊物品监管的不同进行比对,并提出提升药物、疫苗、诊断试剂相关关键原料辅料、中间产物、原液等物品进口手续的可操作性,以促进生物医药产业发展、通过联合监管等形式完善进出口监管、形成新型中美药监、海关合作关系的启示。It addresses the issue of the need to improve the regulatory system for special articles related to pharmaceuticals in China.It adopts the method of translating,organizing,and researching the source on the official website of the US government.It systematically elaborates on the organizational structure,regulatory functions,import verification and export certification system about special articles of the US Food and Drug Administration in paper.It compares the different regulatory requirements of China and the US drug regulatory and customs for imported special articles,and proposes to improve the operability of import procedures for key raw materials,excipients,intermediate products,and raw liquids related to drugs,vaccines,and diagnostic reagents to promote the development of the biopharmaceutical industry.It improves import and export supervision through joint supervision forms and forms a new type of cooperation between China US drug regulatory and customs.

关 键 词：美国 FDA 特殊物品 进出口监管 

分 类 号：X830.2[环境科学与工程—环境工程]