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.