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基于对注射剂风险控制认识的不断加深,我国药监部门大幅提高了注射剂的研发及评价的技术要求。近年,注射剂的变更申请数量较大。本文在梳理日常技术审评工作的基础上,结合近年未获得批准的部分注射剂变更申请的案例分析,对注射剂变更研究的思路、现状和存在的问题进行了分析。
Based on the deepening understanding of injection risk control, China’s drug regulatory department substantially increased the technical requirements for R & D and evaluation of injections. In recent years, there has been a large number of change requests for injections. Based on the review of the routine technical review and the case analysis of the application for some injections that have not been approved in recent years, this paper analyzes the train of thought, status quo and existing problems in the study of the change of injections.