中国食品药品监管Issue(7)：68-75,8.DOI:10.3969/j.issn.1673-5390.2024.07.007
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
胡琳琳 1杜昕昱 1李蓓 1白馥萍 1李楚桐 1刘玉1
作者信息
摘要
Abstract
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.关键词
体外诊断试剂/参考区间/注册审查/行业标准/监管建议Key words
in vitro diagnostics/reference intervals/registration review/industry standards/regulatory suggestions分类
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胡琳琳,杜昕昱,李蓓,白馥萍,李楚桐,刘玉..我国体外诊断试剂参考区间监管现状分析和思考[J].中国食品药品监管,2024,(7):68-75,8.
