面部注射填充材料临床应用不良反应及上市前不良反应评价要求分析  

Analysis of adverse reactions of clinical application of facial injection filler materials and pre-market adverse reaction evaluation requirements

作　　者：程玮璐 许菱丹 邱宏 刘英慧 刘露 Cheng Weilu;Xu Lingdan;Qiu Hong;Liu Yinghui;Liu Lu(Center for Medical Device Evaluation,National Medical Products Administration,Beijing 100081,China;Yangtze River Delta Center,Medical Device Evaluation and Inspection,National Medical Products Administration,Shanghai 201210,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100081 [2]国家药品监督管理局医疗器械技术审评检查长三角分中心,上海201210

出　　处：《中国医学装备》2024年第7期165-171,共7页China Medical Equipment

摘　　要：国内外已有多种面部注射填充材料获批上市,搜集国内外面部注射填充材料产品上市批准情况、临床应用文献、专家共识和临床应用指南进行分析,挖掘面部注射填充材料引起的不良反应数据;概述面部注射填充材料的临床应用情况及其产生的不良反应,分析和总结美国及中国对此类产品的上市前不良反应评价要求,为相关产品研发人员及临床研究人员对于面部注射填充材料的上市前不良反应评价提供参考。A variety of facial injection filler materials have been approved for market at home and abroad.The marketing approvals,clinical application literature,expert consensus or clinical application guidelines of facial injection filler products at home and abroad were collected and it was found that facial injection filler materials may cause a number of adverse reactions.The clinical application and adverse reactions of facial injection filler materials were summarized,the pre-market adverse reaction evaluation requirements of such products in the United States and China were analyzed and summarized,aiming to provide reference for relevant product developers and clinical researchers to evaluate the premarket adverse reactions of facial injection filler materials.

关 键 词：面部注射 填充材料 研究进展 不良反应 

分 类 号：R197.39[医药卫生—卫生事业管理]