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1 6 1 Vol. 6 No Journal of Food Safety and Quality Jan., 2015 丰伟刚 1,2, 赵瑜 1, 赵宗阁 1, 洪建文 3, 罗卓雅 3, 尹利辉 (1., ; 2., ; 3., ) 1, 2* 摘要 :,,,,,,,,,, 关键词 : ; ; ; ; Study on the use of big data to promote food and drug smarter supervision FENG Wei-Gang 1,2, ZHAO Yu 1, ZHAO Zong-Ge 1, HONG Jian-Wen 3, LUO Zhuo-Ya 3 1, 2*, YIN Li-Hui (1. National Institutes for Food and Drug Control, Beijing , China; 2.China Pharmaceutical University, Nanjing , China ; 3. Guangdong Institute for Food and Drug Control, Guangzhou , China) ABSTRACT: The article overviewed the concept of big data and the issues of using big data to promote drug smarter supervision, which provided a reference for improving the efficiency of supervision for the drug regulatory departments. The application of big data in the field of pharmaceutical regulation was analyzed from the links of production, circulation, and medication, etc. As national and provincial drug administrations, inspections and enterprises were actively exploring the application on drug supervision by using of the big data, there had been many good instances which showed obvious efficient. However, there were still a lot of problems on big-data construction and application. This article provided some appropriate suggestions of solutions. In conclusion, drug regulatory departments need to improve top-level design, build big-data centers for drug supervision, integrate various system resources, apply the co-operations mode, and accelerate the introduction of relevant laws and regulations. Finally a new situation of drug smarter regulation by using big data will be created. KEY WORDS: big data; production quality control system; electronic supervision network; adverse drug reaction supervision center; big data center of drug supervision 1 引言 ,,,, [1] , * 通讯作者 :,, yinlihui@vip.163.com *Corresponding author: YIN Li-Hui, Chief of Pharmacist, China Pharmaceutical University, Nanjing , China. yinlihui@vip.163.com

2 1, : 355,,,,, [2] 2014,,, (big data),,, =, ;,,,,, [3],,,,,,,, 2 大数据概述 2.1 大数据的定义及其特点,, [4], [5],,, [6],,,, 2.2 大数据的价值链, ;, :,, [7],, [8] 2.3 大数据在公共卫生行业应用的实例,, ,, 4.5, 45,, , 97%,,,, 2009 H 1 N 1,, :,,,,,, 3 大数据在我国药品监管领域应用的现状,,,, 3.1 利用大数据从生产源头监控药品质量 (GMP),,, [9],,,, [10], 3 50, 500,, 药品电子监管网定义 [11],, 实施药品电子监管的必要性,

3 356 6, 2006,,, 15000, 3000,, 2007,,, 10,,, [12] [13] 我国药品电子监管网建设历程 2006, ; , ; , 电子监管码的作用, [14], 2,, 3.3 药品不良反应监测数据的挖掘我国药品不良反应监测体系信息化建设的进程 (adverse drug reaction, ADR) [15] Fig. 1 1 Structure diagram of production process quality control system Fig. 2 2 Lifecycle of electronic drug supervision code

4 1, : 357, 2001,, 2001~2002,, , ,, 2003 [16] 不良反应监测数据的挖掘 [17], 2440,,, [18] 4491,, 14, [19] ADR, ADR, ADR,,,, ADR, ADR,,, 4 大数据在推进药品监管方面存在的问题 4.1 药品监管信息化顶层设计不足,,,,,,,,, 4.2 大数据应用存在单兵作战,,,,,,,, 4.3 不良反应数据的采集质量有待提高,, ADR,, : % [20], 2011~2012, 94%, [21],, :,, % [22], ( %) 4.4 大数据安全隐患,,,,, [23], 5 推进药品智慧监管的解决方案 5.1 强化顶层设计, 建设数据中心,,,,,,,,,,,,, 3,, 5.2 提高数据采集质量, 消除数据安全隐患,,,

5 358 6 Fig. 3 3 Schematic diagram of big-data center structure for drug supervision, [24],,,,,,, 5.3 加强数据中心的应用,,,,, [25],,,,,,,,,,,,,,,,,,,,,,,, [26],, ADR,,,,, ADR,, ADR ADR 5.4 加强大数据技术人才队伍的建设,,,,, 6 总结与展望,, :

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360 6 Adv React Newsl, 2012, 22(3): 3 6. [23]. [D]. :, 2012. Jing XH.

supervixion code [D]. Hangzhou: Zhejiang University of Technology, 2012. [24],,,. [J].

Inves tigation of Adverse Drug Reaction monitoring progress of Shandong province [J].

Hebei use of big data to promote the big drug regulation [N].

Analysis of the Existing Problems in the Drug Manufacturing and Drug Supervision andmanagement

7 360 6 Adv React Newsl, 2012, 22(3): 3 6. [23]. [D]. :, Jing XH. Discussion of advantages and disadvantages on the pracrical appliacation of drug electronic supervixion code [D]. Hangzhou: Zhejiang University of Technology, [24],,,. [J]., 2007, 3: Kong QY, Zhou Y, Tian YJ, et al. Inves tigation of Adverse Drug Reaction monitoring progress of Shandong province [J]. Chin J Pharmacovigiliance, 2007, 3: [25]. [N]., Song HX. Hebei use of big data to promote the big drug regulation [N]. China Pharm Med Newspaper, [26]. [J]., 2008, 10: Cheng XL. Analysis of the Existing Problems in the Drug Manufacturing and Drug Supervision andmanagement From the Qi Er Yao Counterfeit Event and Xin Fu Drug Accidents [J]. Chin Pharm Aff, 2008, 10: 作者简介 ( 责任编辑 : 白洪健 ) 丰伟刚, 药学硕士在读, 主要研究方向为药物分析 fengweigang2624@163.com 尹利辉, 主任药师, 主要研究方向为药物分析, 药品快速检测 yinlihui@vip.163.com

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<4D6963726F736F667420576F7264202D203631372D3632312032303133303430333030312DBACEC0F25FD0A3B6D4B8E55F2DB6FED0A32D2D2DC8A5B5F4CDBCD6D0B5C4BBD8B3B5B7FBBAC52E646F63> 第 4 卷第 2 期食品安全质量检测学报 Vol. 4 No. 2 2013 年 4 月 Journal of Food Safety and Quality Apr., 2013 何莉 *, 姜笑寒 ( 广东省食品药品职业技术学校, 广州 510663) 摘要 : 本文通过科学地运用 html5+jsp+sql 技术, 建