摘要
美国、欧盟、日本等国家或组织持续推进安全、可靠、高效的药品监管信息电子提交体系的建设和应用,其中美国的eCopy、eSubmitter、ESG等药品监管信息电子提交工具建设相对较早、使用较久且相对成熟.为此,本文在概要分析美国、欧盟、日本药品监管信息电子提交体系的基础上,重点就美国药品监管信息电子提交体系进行分析.再结合我国现状和要求,对比国外建设情况,总结得出不断强化体系化设计、持续完善标准规范、进一步确保网络和数据安全等关键点,以期助力国内药品监管信息电子提交等有关信息化系统的建设.
Abstract
Countries or organizations such as the United States,the European Union and Japan continue to promote the construction and application of safe,reliable,and efficient electronic submission systems for drug administration information.The electronic submission systems for drug administration information in the United States,such as eCopy,eSubmitter,and ESG,were established early,and have been used for a long time.This paper briefly introduced the electronic submission systems for drug administration information in the United States,the European Union,and Japan,and focused on analyzing the one in the United States.After comparing the situation abroad,we summarized key points such as continuously strengthening systematic design,improving standard specifications,and further ensuring network and data security,to assist in the establishment of electronic submission of drug administration system in China.
NETL
NSTL
万方数据