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新形势下我国药品特别审批制度的思考 被引量:4

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摘要 我国药品监管部门在此次新冠肺炎疫情突发公共卫生事件应对中,特别审批了部分药品的临床试验和医疗器械产品,有力地支撑了疫情防控工作,取得了较好的成效。本文结合此次疫情防控中我国特别审批的实践,针对我国药品特别审批制度面临的问题,从国家安全、高规格协调机制、特别审批的具体实施程序制度等方面,为国家应对突发安全事件时做好相应特别审批制度提出了思考和建议。 In responding to the public health emergency,the novel corona virus pneumonia outbreak,China's drug regulatory authorities have specially approved the clinical trials of some drug sand medical device products,which strongly supports the epidemic prevention and control work and achieves good results.Aiming at the issues exposed in the Special Review and Approval Procedures,this article combs the practice of China's special approval for disease prevention and control in this outbreak in order to put forward suggestions pertaining to the improvement of the procedures from the aspects of national security,high-standard coordination mechanisms,and implementation procedures.
出处 《中国食品药品监管》 2020年第9期30-35,共6页 China Food & Drug Administration Magazine
关键词 突发公共卫生事件 药品 特别审批制度 public health emergencies medicine special review and approval procedures
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