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

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.