摘要
目的:分析研究江苏省药品生产监管信息化系统建设情况,为药监部门持续改进信息化建设、推进药品智慧监管提供参考。方法:对江苏省药品生产监管信息系统建设现状进行梳理分析。结果:现有信息系统在数据采集、数据交换、数据分析应用等方面在适应新形势下新药品生产监管模式尚有不足。结论:监管部门应建立健全信息化系统管理制度、拓展数据采集渠道、加强数据安全保护、强化数据分析应用、注重信息化建设人才培养,着力提升信息化系统推进药品智慧监管的能力。
Objective:To analyze and study the construction of pharmaceutical production supervision informatization system in Jiangsu province,so as to provide reference for the pharmaceutical supervision department to continuously improve the informatization system construction and promote the intelligent supervision system.Methods:This paper analyzes the current situation on the construction of drug production informatization system in Jiangsu province.Results:The existing informatization system should be improved in data collection,data exchange,data analysis and application to adapt the new situation of drug production supervision mode.Conclusion:Regulatory authorities should establish and improve the management system of informatization,expand data collection channels,strengthen data security protection,strengthen data analysis and application,pay attention to personnel training,and strive to enhance the ability of intelligent supervision.
作者
张书卉
曹嘉成
王金伟
焦灵利
ZHANG Shuhui;CAO Jiacheng;WANG Jinwei;JIAO Lingli(Certification Inspection of Jiangsu Food and Drug Administration Certification Evaluation Center,Nanjing Jiangsu 210002,China)
出处
《药品评价》
CAS
2021年第17期1028-1031,共4页
Drug Evaluation
关键词
信息化系统
智慧监管
药品生产
Informatization system
Intelligent supervision
Drug production
