中国药物评价2024，Vol.41Issue(2)：93-96,4.
新版《血液透析浓缩物注册审查指导原则》的研究探讨
Research and Discussion on the"Guidelines for Registration and Review of Hemodialysis Concentrates"
杨宇希 1骆庆峰1
作者信息
- 1. 国家药品监督管理局医疗器械技术审评中心,北京 100081
- 折叠
摘要
Abstract
Objective:Based on the clinical application of hemodialysis concentrates,this study explores the specific requirements and objectives of the newly revised"Guidelines for Registration and Review of Hemodialysis Concentrates".Methods:Through literature a-nalysis,combined with the revision process of registration review guidelines,analyze the risk points of blood dialysis concentrate products,and explain the changes in the new version of evaluation requirements.Results:Pre market evaluation,as a crucial step in market access for hemodialysis concentrates,plays an important role in ensuring product quality.The new version of the guiding principles keeps pace with the times and adapts to the current product development and registration application situation.Conclusion:The new guiding princi-ples clarify the principles and requirements for the safety and effectiveness evaluation of concentrate products,effectively unify the evalua-tion scale,and serve the high-quality development of the industry.关键词
医疗器械/风险管理/安全性/注册/血液透析Key words
Medical devices/Risk management/Safety/Registration/Hemodialysis分类
医药卫生引用本文复制引用
杨宇希,骆庆峰..新版《血液透析浓缩物注册审查指导原则》的研究探讨[J].中国药物评价,2024,41(2):93-96,4.
