大数据时代药品质量监管体系发展趋势

Development trend of drug quality supervision in big data era

大数据的应用开启了一门新科学——数据科学。数据科学研究可主要归纳为数据、分析/处理方法与应用3个方面,但其最终目的是发现问题、提出问题、解决需求。截至2015年,国家食品药品监督管理总局及直属单位的多个网络平台及相应的专业数据中心已建成并先后投入使用,使得研究人员可以有效的利用各种算法结合可视化,清晰地展现隐含在各类专业数据库之间的药品风险规律,实现向公众准确、及时(动态)地发布药品质量信息;发现上市药品的共性质量问题等,并有望通过实施追踪系统,保障药品的质量;根据药品的关键质量属性,设置各类警戒线,及时发现各类生产、贮存、流通、使用中的隐患,为药品监管部门的管理与决策提供可靠支持,进而最终实现"智慧监管"。

Application of big data emerges a new specified profession,data science. Study on data science focuses on three aspects： data,technique,and application,but the final aim is to discover problems,summarize questions,and solve the demands. Up to the year 2015,multiple network platforms with professional data libraries,which belong to the China Food and Drug Administration（ CFDA） and its affiliated institutions,have been put into use successively. This makes it possible to show clearly the risk pattern of drugs hidden in those professional databases with algorithm combining visualization,to broadcast drug quality information dynamically,accurately and timely to the public,and to find some common quality problems of final products on the market. Also,it makes it hopeful to guarantee the quality of drugs through a tracking system and to find timely all kinds of hidden problems in the production,storage,distribution and use according to their critical quality attributes by setting some warning lines,and to provide reliable support for decision-making for authorities,thus finally realize smart supervision.