药品评价抽验的综合管理模式研究

Integrated management mode of post-marketing quality evaluation of drugs

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。

Quality evaluation of drugs is a significant method of post-marketing surveillance,meanwhile a focus of the big data strategy at present. As a result,efficient management has become a necessity to each quality control institute in the situation of limited time and heavy tasks. As an organizing unit,the Institute for Chemical Drug Control had completed the job efficiently in a standardized management mode,which was based on retrospective studies and including twelve new strategies. The idea won the second place in the Management Innovation Contest of NIFDC in 2015. In order to comb the integrated management mode,we overviewed the records in recent years and analyzed the key points of implementation. Then some solutions were proposed which could improve the efficiency of post-marketing quality evaluation of drugs greatly.