某院临床急需进口药品申请问题分析与建议——乐城先行区急需进口药品助力真实世界研究  

Analysis and Suggestions on the Application for Urgently Needed Imported Drugs in a Certain Hospital:Empowering Real World Study in Lecheng Pilot Zone

作　　者：王芳[1] 刘云鹏 许倍铭[1] 顾志冬[3] WANG Fang;LIU Yun-peng;XU Bei-ming;GU Zhi-dong(Ruijin Hospital,Shanghai Jiaotong University School of Medicine;Hainan University;Ruijin-Hainan Hospital,Shanghai Jiaotong University School of Medicine(Hainan-Boao Research Hospital))

机构地区：[1]上海交通大学医学院附属瑞金医院 [2]海南大学 [3]上海交通大学医学院附属瑞金医院海南医院(海南博鳌研究型医院)

出　　处：《中国食品药品监管》2023年第10期54-59,共6页China Food & Drug Administration Magazine

基　　金：上海申康医院发展中心第二轮《促进市级医院临床技能与临床创新三年行动计划》研究型医师创新转化能力培训项目(项目编号:SHDC2022CRS037);真实世界研究项目(2022年度)(项目编号:HNLC2022RWS014)。

摘　　要：本论文通过分析临床急需进口药品当前在上海交通大学医学院附属瑞金医院海南医院申请及审批环节的现状,探讨临床急需进口药品资料在申请审批环节中存在的问题。研究发现,在临床急需进口药品的首次申请中,审批无驳回的申请耗费时间会大大缩短。通过分析临床急需进口药品申请资料,发现其中主要问题为基本资料信息缺失、不全,信息不一致等,建议加强业务培训,提高申请资料质量,加强沟通,提高审批效率,从而达到缩短药品审批环节的消耗时长,加快国际创新临床药品落地乐城先行区。This paper analyzes the current status and related issues of the application and approval process of clinically urgently needed imported drugs in Ruijin-Hainan Hospital,affiliated with Shanghai Jiaotong University School of Medicine.The study finds that the time required for approval without rejection is greatly reduced in the first application for clinically urgently needed imported drugs.Analysis of the issues in the application materials for clinically urgently needed imported drugs reveals problems such as missing or incomplete documents and inconsistent basic information.It is recommended to strengthen business training,improve the quality of application materials,enhance communication,and improve approval efficiency.These measures aim to shorten the duration of the drug approval process and accelerate the implementation of international innovative clinical drugs in the Lecheng Pilot Area.

关 键 词：临床急需进口药品 资料问题 改进建议 

分 类 号：R9[医药卫生—药学]