我国新药优先审评模式研究

发布时间：2018-08-04 13:27

【摘要】：本文从我国新药优先审评模式的前身——特殊审批制度出发,通过构建评价指标体系,回顾特殊审批制度实施绩效,并在借鉴国外优先审评模式的基础上,结合我国国情和药品审评审批改革目标,提出优先审评模式的完善建议。建议从适用范围分类细化、加速审评时间节点设置、审评团队建设三方面优化优先审评模式。
[Abstract]:Based on the special examination and approval system, which is the predecessor of the new drug priority review model in China, this paper reviews the performance of the special examination and approval system through the construction of the evaluation index system, and on the basis of drawing lessons from the foreign priority review model, According to the situation of our country and the target of drug review and approval reform, the paper puts forward some suggestions on how to perfect the mode of priority review. It is suggested that the priority review mode should be optimized from three aspects: the classification of the applicable scope, the acceleration of the setting of the review time node and the construction of the review team.
【作者单位】：中国药科大学;国家食品药品监督管理总局药品审评中心;
【分类号】：R95

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