Supervision Administration

On Application of Quality Data Analysis System in Drug Supervision and Management

Expand
  • Chongqing Institute for Food and Drug Control, Chongqing 401121 , China

Online published: 2021-11-05

Abstract

Objective: To explore the effective ways of “smart supervision” on drug safety risks and promote the transformation and upgrading of drug supervision models. Methods: According to the data of drug test results and adverse reaction information, the quantitative evaluation system of drug quality was explored and established. The drug quality data analysis system was constructed on the basis of the drug quality database established in the early stage and the established drug quality quantitative evaluation system. The application of data analysis system in drug supervision was deeply developed from the functions of quality information report and quality risk information reminder, etc. Results and Conclusion: The quantitative evaluation system of drug quality could preliminarily finish the quantitative evaluation of each batch of drugs entering the drug quality database. The main functions of drug quality data analysis system included data storage service, data model service, data release service and data applications. Application of data analysis system in drug supervision mainly included the generation of drug quality information reports and drug quality risk information reminders. It could timely screen out the information of high-risk varieties, discover the problems, guide drug regulatory authorities to implement precisely targeted intervention, and make scientific sampling plans so as to provide technological support in practicing the concept of "smart drug supervision" for drug supervision departments.

Cite this article

Ren Xueyi, Yang Huilian, Li Xulun, Zou Jiang . On Application of Quality Data Analysis System in Drug Supervision and Management[J]. Chinese Pharmaceutical Affairs, 2021 , 35(10) : 1087 -1093 . DOI: 10.16153/j.1002-7777.2021.10.001

References

[1] United Nations Global Pulse.Big Data for Development:Opportunities and Challenges-White Paper[EB/OL].(2012-05-30)[2021-04-21].https://www.unglobalpulse.org/document/big-data-for-developmentopportunities-and-challenges-white-paper.
[2] 王飞跃,王晓,袁勇,等.社会计算与计算社会:智慧社会的基础与必然[J].科学通报,2015,60(5-6):460-469.
[3] 胡芳.“十三五”让百姓饮食用药安全无忧——专访国家食品药品监督管理总局局长毕井泉[J].中国食品药品监管,2017(3):11-12.
[4] 张耀祺.创新药品信息化监管,打造“智慧药监”新格局[J].中国市场监管研究,2018(6):62-65.
[5] 宋春艳,王小宁,辛蕾.创新药品监管方式打造智慧监管新格局[J].中国食品药品监管,2020(3):54-59.
[6] 胡昌勤,成双红.大数据时代药品质量监管体系发展趋势[J].中国新药杂志,2016,25(20):2284-2286.
[7] 杨善林,周开乐.大数据中的管理问题:基于大数据的资源观[J].管理科学学报,2015,1(5):1-8.
[8] 陈纯,庄越挺.大数据智能:从数据到知识与决策[J].中国科技财富,2017(8):48-49.
[9] 卢日刚,陈薇,苏浩.基于大数据的食品药品检测数据管理系统构建设想[J].中国药事,2016,30(7):661-665.
[10] 孙京林,余伯阳.药品上市许可持有人制度下的质量管理体系[J].中国药学杂志,2020,55(23):1919-1922.
[11] 中共中央办公厅,国务院办公厅.厅字[2018]53号关于印发《国家药品监督管理局职能配置、内设机构和人员编制规定》的通知[S].2018.
[12] 钟永成,王伟.药品生产企业质量管理现状分析及改进策略研析[J].法制博览,2016(13):164-165.
[13] 于洪,何德牛,王国胤,等.大数据智能决策[J].自动化学报,2020,46(5):878-896.
[14] 赵萍,刘俊,楼双凤.以大数据分析为指引探索药品质量量度监管[J].工商行政管理,2017(19):43-44.
[15] 马进.以建设药品品种档案为例探讨主数据管理在药品监管领域的应用[J].中国药事,2018,32(9):1172-1175.
[16] 杜林林,梁毅,周亚娴,等.以质量管理为突破的药品智慧监管新尝试——基于贵阳信息化案例分析[J].中国医药导刊,2020,22(9):650-653.
Options
Outlines

/