伴随诊断试剂的监管浅析

目的：介绍伴随诊断试剂的历史、发展以及各国的监管政策,为我国体外诊断试剂行业相关从业人员提供参考信息。方法：从美国伴随诊断试剂的发展、监管政策的发展、相关指导原则、监管面临的挑战以及各国的监管现状等五个方面,浅析伴随诊断试剂的监管情况。结果与结论：伴随诊断试剂能精准地评估不同患者对个体化药物的治疗受益程度以及潜在副作用与风险,对于保证个体化药物的安全性与有效性至关重要,此外还能够加快新的个体化药物研发流程、缩短临床试验时间以及降低研发成本。因此,越来越多的制药公司与体外诊断试剂公司积极推进"个体化药物-伴随诊断试剂"联合研发,各国监管部门也积极响应行业和市场的需求。根据伴随诊断试剂的特点制定合理的监管政策,有助于伴随诊断试剂的发展及精准医学的普及。

Brief Analysis of the Regulation of Companion Diagnostics

Objective: To introduce the history, development and regulatory policies of companion diagnostics (CDx) of various countries and to provide reference information of CDx for in vitro diagnostics industry related practitioners in China. Methods: The regulatory situation of the CDx was briefly analyzed from the following fve aspects, the development of CDx in the United States, the development of the relevant regulatory policies, the related guidelines, the regulatory challenges and the current regulatory status of various countries. Results and Conclusion: The CDx can accurately assess the degree of therapeutic benefits and potential side effects and risks of the treatment of individualized drugs on different patients and is essential to ensure the safety and effcacy of individualized drugs. In addition, the CDx can also accelerate the development of new individualized drugs, shorten clinical trial time and reduce the research and development costs. As a result, more and more pharmaceutical companies and in vitro diagnostics companies actively promote the joint research and development of the "individualized drugs and CDx", which is also actively supported by regulatory departments in various countries to meet the needs of the industry and the market. To develop reasonable regulatory policies according to the characteristics of CDx is helpful for the development of CDx and the popularization of precision medicine.