伴随诊断试剂监管分析与思考  

Analysis and Thinking on the Supervision of Companion Diagnostic Reagents

作　　者：弓志军 吴守信 姜慧慧 GONG Zhijun;WU Shouxin;JIANG Huihui(National Medical Products Administration Institute of Executive Development,Beijing 100073,China;Department of Research,Shanghai Zhangjiang Medical Innovation Institute,Shanghai 200120,China;Department of Scientific Research,Shanghai Biotecan Medical Diagnostic Center Corporation,Shanghai 200120,China)

机构地区：[1]国家药品监督管理局高级研修学院,北京100073 [2]上海张江医学创新研究院研究部,上海200120 [3]上海宝藤医学检验所有限公司科研部,上海200120

出　　处：《中国医疗设备》2023年第5期173-179,共7页China Medical Devices

摘　　要：精准医疗高度依赖体外诊断(In Vitro Diagnostic,IVD),当IVD用于识别适合接受特定药物治疗的患者时,又被称为伴随诊断(Companion Diagnostics,CDx),基于CDx试剂重要的临床价值和经济效益,制定科学、完善的CDx监管政策不仅有利于CDx行业正向、均衡发展,而且有助于精准医疗的普及。本文比较各国CDx试剂的监管现状,梳理CDx试剂监管面对的挑战,分析我国CDx试剂监管趋势及监管难点,并展望CDx行业未来发展趋势,以期为我国新药研发和CDx领域从业人员和监管人员提供一定的参考依据。Precision medicine highly relies on in vitro diagnostic(IVD),which is also known as companion diagnostics(CDx)when IVD is used to identify patients who are suitable for receiving specific drug treatment.Based on the important clinical value and economic benefits of CDx reagent,the formulation of scientific and perfect regulatory policies for CDx is not only conducive to the positive and balanced development of CDx industry,but also conducive to the popularization of precision medicine.This paper compared the present situation of CDx reagent supervision in various countries,summarized the challenges faced by CDx reagent regulation.Meanwhile,the trends and difficulties of CDx reagent supervision were analyzed,and the future development trend of CDx industry was prospected,in order to provide reference for Chinese practitioners and regulators in the field of new drug development and CDx.

关 键 词：精准医疗 伴随诊断 体外诊断 试剂 监管 

分 类 号：R197.39[医药卫生—卫生事业管理]