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药品评价性抽验是上市后监管的重要手段,也是目前大数据战略的热点。然而对于每个承检机构而言,时间紧、任务重已逐步成为常态,因此高效管理已成为必需。作为评价抽验的组织管理部门之一,中国食品药品检定研究院化学药品检定所在回顾性研究的基础上,形成流程化管理模式;通过采取4个基本策略,在高效完成评价抽验工作的同时,在12个方面取得了突破,因此相关思路也在2015年度中国食品药品检定研究院管理创新工作评比中获奖。本文通过对多年的抽验材料进行研究,梳理组织管理脉络,分析实施要点,为提高药品评价抽验管理的工作效率提供参考。
Evaluation of drug evaluation is an important means of regulation after listing, but also the current focus of big data strategy. However, for each inspection agency, time is tight and tasks have become more and more normal. Therefore, efficient management has become a necessity. As one of the organizational management departments of evaluation sampling, the CFTC of China Food and Drug Administration established a process management model based on the retrospective research. By adopting 4 basic strategies, while carrying out the evaluation and evaluation work efficiently, 12 aspects made a breakthrough, so the relevant ideas are also in the 2015 China Institute of Food and Drug Administration innovation and management award winning. In this paper, through years of testing materials to study, sort out the context of organizational management, analysis of the implementation of key points, to improve the efficiency of drug evaluation test management provide a reference.