Objective: To carry out the application research on the digital reporting system of national drug sampling work in order to increase the efficiency of national drug supervision. Methods: According to the characteristics of national drug sampling inspection, the digital reporting system of national drug sampling inspection was developed. The design and implementation of the digital system, the work flow and the whole process maintenance of the digital system were studied, and the effectiveness of the digital system was discussed. Results: The digital reporting system of national drug sampling inspection could automatically realize the electronic generation of national drug sampling inspection report so that the digital reports among different departments could be connected and transmitted, and the authenticity of digital reportscould be quickly queried online. Through routine maintenance, the digital reporting system could effectively promote the operation of national drug sampling inspection. Conclusion: The digital reporting system ensured the efficient and safe operation of national drug sampling work, played an active and effective supporting role in the quality supervision of drugs after listing, and also provided references for the construction of similar digital reporting systems.
Feng Lei, Wang Chong, Zhu Jiong
. Application Research of Digital Reporting System in National Drug Sampling Supervision[J]. Chinese Pharmaceutical Affairs, 2022
, 36(5)
: 491
-496
.
DOI: 10.16153/j.1002-7777.2022.05.002
[1] 刘文,朱炯,胡骏,等.《药品质量抽查检验管理办法》与《药品质量抽查检验管理规定》中检验和复验内容的对比分析[J].中国药房,2020,31(14):1665-1670.
[2] 中国食品药品检定研究院.机构设置[EB/OL].(2019-05-09)[2021-12-01].https://www.nifdc.org.cn/nifdc/jgshzh/zjyzzhjg/20190509145500303.html.
[3] 胡和斌.药品质量公告在药品监管中的应用[J].海峡药学,2004(9):168-169.
[4] 刘文,朱炯,王翀.国家药品抽检风险管理主要举措分析与建议[J].中国药学杂志,2020,55(16):1394-1398.
[5] 高志峰,项新华,朱炯.国家药品抽检中药品标准的适用性研究[J].中国药学杂志,2019,5(3):240-244.
[6] 国家药品监督管理局.国药监药管
[7] 郗昊,冯磊,朱炯,等.基于大数据技术的信息共享平台辅助国家药品抽检工作现状分析及展望[J].中国医药导刊,2019,21(1):50-54.
[8] 朱炯,王胜鹏,刘文,等.国家药品抽检药品质量提示数据分析与探讨[J].中国药事,2020,34(8):909-915.
[9] 刘先文,刘红梅,傅永红,等.胃镜电子报告图像图片管理系统的临床应用[J].中国中西医结合脾胃杂志,2000(1):49.
[10] 陈炜美,陆龙星,吴潮标.探究一种检验检测电子报告加密与防篡改的标准处理方法[J].大众标准化,2020(16):226-228.
[11] 姜文凤,张永策,宿艳.“双一流”建设中实验教学平台构建及应用研究[J].实验技术与管理,2019,36(6):16-20.
[12] 陈慰.浅谈特种设备电子检验报告档案管理[J].特种设备安全技术,2016(4):58-60.
[13] 林道建,苏广校.医院传染病报告信息化管理优势与不足[J].中国卫生产业,2016,13(23):112-114.
[14] 从卫春.医院电子报告管理系统的开发与应用[J].电脑知识与技术,2015,11(33):1-5.
[15] 周悦鹏,李玥琦,王翀.国家药品抽检工作中抽样流程管理研究[J].中国药事,2020,34(10):1124-1129.
[16] 王皓,孙艳杰.确保药品抽样工作质量的新举措[J].临床医药文献电子杂志,2018,5(88):194.DOI:10.3877/j.issn.2095-8242.2018.88.160.
[17] 王美.计算机网络安全与数据完整性技术[J].电子技术与软件工程,2021(12):237-238.
[18] 金保林.数据加密技术在计算机网络安全管理中的应用[J].电子世界,2021(16):178-179.
[19] 王勇,朱方金,史清华.PKI中数字时间戳技术[J].大连理工大学学报,2003,43(21):27-29.
[20] 李剑锋.计算机基础中网络信息安全数据加密技术[J].通信电源技术,2021,38(4):207-209.
[21] 刘静,朱嘉亮,冯磊,等.2020年国家药品抽检中成药质量状况分析[J].中国现代中药,2021,23(5):755-759.
[22] 刘静,王翀,冯磊,等.基于国家药品抽验工作的中成药质量和安全问题分析[J].中国现代中药,2019,21(3):279-283.[2019] 34号关于印发药品质量抽查检验管理办法的通知[EB/OL].(2019-08-12)[2021-12-01].http://wwww.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20190819083201949.html.
