| 张静,关月月,揣红梅,唐桃群,潘威,杨悦.美国FDA药品监管法规数据库建设对我国的启示[J].中国药事,2021,35(12):1414-1418 |
| 美国FDA药品监管法规数据库建设对我国的启示 |
| The Enlightenment of US FDA Drug Regulation Database Construction to China |
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| DOI：10.16153/j.1002-7777.2021.12.013 |
| 中文关键词: 美国食品药品监督管理局 法律 法规 指南 数据库 药品监管 |
| 英文关键词: FDA laws regulations guidance database drug regulation |
| 基金项目:国家药品监督管理局信息中心委托课题(编号 CFDAIC-XXFW-201896) |
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| 中文摘要: |
| 目的： 研究美国食品药品监督管理局(FDA)药品监管法规文件数据库的构建，为完善我国药品监管法规文件数据库提供参考。方法：详细介绍FDA药品监管法规文件数据库的构成及功能，为我国数据库的进一步完善提出建议。结果与结论：FDA网站建立了相对完善的药品监管法规文件数据库，其结构的逻辑性、资源的完整性及检索功能的便捷性均存在可借鉴之处。 我国正在探索建设、完善药品法规数据库，其系统性与科学性需要不断提高，从而更好地满足公众及行业需求。 |
| 英文摘要: |
| Objective: To study the construction of regulation document database of FDA in order to provide references for the improvement of drug regulation document database in China. Methods: The constitution and functions of the database of drug regulation documents of FDA were introduced in detail, and some suggestions for the further improvement of database in China were put forward. Results and Conclusion: FDA website has established a relatively complete database of drug regulation documents, which can be used for reference in the logicality of structure, integrity of resources and convinience of retrieval functions. China is trying to build and perfect the database of drug laws and regulations, but the systematicness and scientificity need to be improved so as to better meet the needs of the public and the industry. |
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