关键词: 审评数据, 数据中心, 信息孤岛, 数据整合

Abstract: The food and drug administration departments at all levels, as well as their technical support departments, have all established the corresponding computer business operation systems to meet their respective functions. Based on the vast amount of data produced from these business operation systems, how to manage resource integration and data sharing is one of the priorities during the medical device regulatory informationization. This article, taking the data generated from the domestic third-class and imported medical device registration review process responsible by SFDA as an example, tries to clarify the definitions of the review data and its data center, and to analyze the current status of the quality and utilization of the medical device registration review data as well as the necessity of data integration. Based on the actual registration review process, this article proposes the practical implementation strategy and procedures of the data integration, aiming to building up the basic preparation work on the national medical device registration review data integration, and further serves the construction of the state food and drug (medical device) regulatory data center.

Key words: review data, data center, information silo, data integration