美国FDA数据标准项目研究及对我国的启示
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篇名: 美国FDA数据标准项目研究及对我国的启示
TITLE: Research on FDA Data Standards Program in the United States and Its Enlightenment to China
摘要: 目的:研究美国FDA的数据标准项目,为我国药品数据标准建设提供借鉴。方法:通过分析美国FDA数据标准项目的治理组织机构和政策体系,总结其数据标准开发模式和开发流程的相关经验,并对我国相应的药品数据标准建设提出建议。结果与结论:美国FDA数据标准项目的组织机构是以FDA的首席科学家办公室为领导,数据标准咨询委员会统筹协调,药品评审与研究中心下辖的数据标准委员会具体负责,FDA下辖的其他监管中心和办公室多元参与的组织构架。该项目是由数据标准战略、数据标准项目行动计划、数据标准目录、数据标准项目沟通计划等4个子系统构成。数据标准战略是FDA根据美国联邦法律法规、其自身和医药行业对数据标准的需求状况以及数据标准的重要性程度等提出的数据标准开发战略目标;通过数据标准项目行动计划将战略目标细化为具体的项目;这些项目严格遵循“数据标准开发流程”分季度逐步推进,新的数据标准将被纳入《数据标准目录》;同时,FDA通过数据标准项目沟通计划强化与内外部利益相关者的沟通合作。建议我国借鉴美国FDA数据标准项目建设经验,通过建立医疗卫生数据标准项目管理模式,强化内外部利益相关者参与、建立数据标准委员会,制定数据标准目录,为医药行业提供明确、统一的数据标准等方式,推动我国药品数据标准的建设。
ABSTRACT: OBJECTIVE:To study FDA data standards program in the United States ,and to provide reference for constructing medicine data standards in China. METHODS :By analyzing the governance organization and policy system of FDA data standards program in the United States ,the experience were summarized for data standards development mode and development procedure , and relevant suggestions were put forward for medicine data standards construction in China. RESULTS & CONCLUSIONS :The organization of FDA data standards program is led by the Chief Scientist Office of FDA ,coordinated by the Data Standards Advisory Board ,specifically responsible by the Data Standards Program Board under the center for Drug Evaluation and Research , and participated by other regulatory centers and offices under FDA. FDA data standards program is composed of 4 subsystems as data standards strategy ,data standards program action plan ,data standards catalog and data standard communication plan. According to the federal laws and regulations of the United States ,the demand of FDA and pharmaceutical industry for data standards and the importance of data standards ,the strategic objectives of data standards development are proposed ,and the strategic objectives are refined into specific projects through the data standards program action plan. These programs strictly follow the“data standards development process ”and gradually advance quarterly ,and new data standards will be included in the Data Standards Catalog . At the same time ,FDA strengthen the cooperation and communication with internal and external stakeholders through the data standards program communication plan. It is suggested that China should learn from the experience of FDA data standards program construction ,establish a medical and health data standards program management mode ,strengthen the participation of internal and external stakeholders ,establish data standards committee ,formulate data standards catalog ,and provide clear and unified data standards for the pharmaceutical industry ,so as to promote the construction of medicine data standards in China.
期刊: 2020年第31卷第20期
作者: 成照根,黄璜,林梦瑶
AUTHORS: CHENG Zhaogen ,HUANG Huang ,LIN Mengyao
关键字: 美国FDA;数据标准;数据标准战略;数据标准项目
KEYWORDS: US FDA ;Data standards ;Data standards strategy ;Data standards program
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