摘要
该研究从技术审评的角度梳理对比了中国、美国、欧盟等对过敏原检测试剂的上市前监管要求,结合上市后不良事件监测情况、可参考的标准和国内外法规依据文件,分析了该产品的监管风险和性能要求。针对该产品国内临床试验难、具有可比性的对比试剂难找、缺乏临床诊断金标准等“卡脖子”问题进行了探讨并给出监管建议,以期为该领域的产品研发生产和审评审批监管提供技术参考。
In the perspective of technical evaluation, the pre-marketing regulatory requirements of allergen detection reagents in China, America, European Union were compared, and the regulatory risks and performance requirements of this product were analyzed based on the monitoring of post-marketing adverse events, reference standards and domestic and foreign regulatory documents. In view of the "neck-stuck" problems such as the difficulty of clinical trials, the difficulty of finding comparable contrast reagents and the lack of clinical diagnostic gold standards, this paper discusses and gives regulatory suggestions, with a view to providing technical reference for product R&D, production, evaluation, approval and supervision in this field.
作者
杨笑鹤
董沁芳
张兰
王宇航
朱文武
YANG Xiaohe;DONG Qinfang;ZHANG Lan;WANG Yuhang;ZHU Wenwu(Zhejiang Center for Medical Device Evaluation(Zhejiang Provincial Center of Medical Device Adverse Events Monitoring),Hangzhou,311121)
出处
《中国医疗器械杂志》
2022年第3期318-322,共5页
Chinese Journal of Medical Instrumentation
基金
浙江省食品药品监管系统科技计划项目(YQ2018005)。
关键词
过敏原
临床试验
金标准
性能指标
溯源性
allergen
clinical trial
gold standard
performance index
traceability
作者简介
杨笑鹤,E-mail:147359549@qq.com。
