我国体外诊断试剂参考区间监管现状分析和思考

Analysis and Reflections on the Regulation of Reference Intervals for In Vitro Diagnostics in China

参考区间是定量体外诊断试剂性能的关键参数,也是体外诊断试剂注册审评的重要关注点。2022年9月,国家药品监督管理局医疗器械技术审评中心发布《体外诊断试剂参考区间确定注册审查指导原则》,作为专门针对体外诊断试剂参考区间监管的指导文件,其为提升体外诊断试剂的准确性和可靠性提供了保障,也对行业产生了积极影响。本文通过对监管部门、相关企业及医学实验室进行访谈,并结合相关文献和数据,对我国体外诊断试剂参考区间的监管现状和问题进行分析。在借鉴国际经验的基础上,提出优化体外诊断试剂参考区间监管的几点思考,包括实施分类管理、允许特殊产品上市后补充数据、允许部分产品同步开展参考区间研究和临床评价、推动参考区间行业标准建立及建立多元合作机制等,以期为完善体外诊断试剂的监管体系提供参考。

Reference intervals are critical parameters for the performance of quantitative in vitro diagnostic reagents and an important focus in the registration and evaluation of these reagents.In September 2022,the Center for Medical Device Evaluation of the National Medical Products Administration in Chian issued the Guiding Principles for the Establishment of Reference Intervals for In Vitro Diagnostics in Registration Review,the first guidance document specifically addressing the regulation of reference intervals for in vitro diagnostic reagents.This document aims to enhance the accuracy and reliability of in vitro diagnostic reagents and has significant impact on the industry.This article analyzes the current situation and existing issues of reference interval regulation in China through literature review,data analysis,and interviews with regulatory authorities,related enterprises,and medical laboratories.Based on international experiences,we propose several recommendations for improving the regulation of reference intervals for in vitro diagnostics in China,including implementing classification management,balancing regulatory efforts across the regulation cycle,allowing the synchronicity of reference interval studies and clinical evaluations,promoting the establishment of industrial standards,and establishing multi-collaboration mechanisms.These suggestions aim to provide insights for improving the regulatory framework of in vitro diagnostic reagents in China.