新型冠状病毒疫情期间医院中药制剂的应急备案申请  

Emergency Filing Application for Traditional Chinese Medicine Preparations in Hospitals During the Outbreak of COVID-19

作　　者：刘敏 刘礼斌 田佳懿 刘洋 陈丽芳 刘炜 Liu Min;Liu Libin;Tian Jiayi;Liu Yang;Chen Lifang;Liu Wei(Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Clinical Rational Drug Use,Joint Laboratory for International Cooperation of Bio-.characteristic Profiling for Evaluation of Clinical Rational Drug Use,Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China)

机构地区：[1]首都医科大学附属北京世纪坛医院,临床合理用药生物特征谱学评价北京市重点实验室,临床合理用药生物特征谱学评价国际合作联合实验室,北京100038

出　　处：《中国药事》2020年第9期1093-1098,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:为疫情防控用医疗机构制剂的应急备案提供参考。方法:结合《北京市药品监督管理局关于对新型冠状病毒感染肺炎疫情防控用医疗机构制剂实施应急审批公告》《北京市医疗机构应用传统工艺配制中药制剂备案管理实施细则》以及我院新型冠状病毒疫情期间中药制剂应急备案申请情况,讨论本次应急备案的申报背景、主要流程、相关材料以及应注意的问题。结果与结论:针对新型冠状病毒疫情期间中药制剂的应急备案审批,简化了申报材料,缩短了审批周期,及时补充了疫情防控用药品的不足。Objective:To provide references for emergency filing of medical institution preparations for the prevention and control of COVID-19.Methods:Combined with the Beijing Drug Administration’s Announcement on Implementing Emergency Approval for Preparations of Medical Institutions for the Prevention and Control of COVID-19,Beijing Medical Institutions’Implementation Rules for the Administration of Filing of Traditional Chinese Medicine Preparations Using Traditional Processes,and the application situation of emergency filing of traditional Chinese medicine preparations in our hospital during the COVID-19 epidemic,this paper discussed the application background,main procedures,relevant materials,and issues that should be noted for this emergency filing.Results and Conclusion:The emergency filing approval of traditional Chinese medicine preparations during the COVID-19 epidemic simplifies the application materials,shortens the approval period,and promptly complements the deficiencies of drugs used for COVID-19 prevention and control.

关 键 词：新型冠状病毒 医疗机构制剂 应急备案 

分 类 号：R95[医药卫生—药学]