美国对实验室研发诊断试剂的监管之路  

Development of the United States regulatory policy about the laboratory developed test(LDT)

作　　者：刘东来[1,2] 石大伟[1,2] 张春涛[1,2] 

机构地区：[1]中国食品药品检定研究院体外诊断试剂2室,北京100050 [2]卫生部生物技术产品检定方法及其标准化重点实验室,北京100050

出　　处：《中国新药杂志》2016年第3期244-252,共9页Chinese Journal of New Drugs

基　　金：国家高技术研究发展计划(863计划)(2011AA02A115)

摘　　要：近年来,基因检测的发展和普及给监管部门带来了巨大挑战。美国通过加强对实验室研发诊断试剂(laboratory developed test,LDT)的监管来应对基因检测带来的风险,其经验被世界卫生组织以及很多国家认可。美国的LDT监管体系涉及众多的法律法规和监管机构。本文围绕美国LDT监管体系中的几个重要组成要素,逐一介绍《临床实验室改进修正案》的发展及其局限性、传统LDT和现代LDT的特点和差异、美国食品药品监督管理局发布的《LDT监督管理框架草案》及其争议和我国的基因检测监管现状。目的是全面将美国的LDT监管政策的发展历程和美国对基因检测的监管情况全面清晰地展现出来,为我国的基因检测体外诊断试剂相关的监管工作提供详尽准确的参考信息。Recently,the development and the popularity of genetic testing brought huge challenges to all regulatory authorities worldwide. As the leader in genetic testing,the United States formulated the regulatory policies regarding laboratory developed test（ LDT）,which was recommended by World Health Organization to all countries regulating genetic testing. Here,the critical factors of the complicated regulatory system of LDT were introduced,including the history of the Clinical Laboratory Improvement Amendments of 1988（ CLIA＇88）,its limitations,the development of LDT,the difference between the traditional and the modern LDT,the draft of the oversight framework regarding LDT issued by the U. S. Food and Drug Administration（ FDA） and its disputations,and the current situation of the regulation of genetic testing in China. The U. S. regulation experiences of the appropriate supervision laws and guidance are the foundation for the regulation of genetic testing. Meanwhile,it is necessary for the relevant regulatory authorities to collaborate closely to implement the policies in China.

关 键 词：基因检测 体外诊断试剂 实验室研发诊断试剂 临床实验室改进修正案 美国食品药品监督管理局 

分 类 号：R95[医药卫生—药学]