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。
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.
[1] 国家药品监督管理局.2020年政府信息公开工作年度报告[EB/OL].(2021-01-28)[2021-09-07].https://www.nmpa.gov.cn/newzwgk/zfxxgknb/2020nb/index.html.
[2] 国家药品监督管理局.2019年政府信息公开工作年度报告[EB/OL].(2020-01-31)[2021-09-07].https://www.nmpa.gov.cn/newzwgk/zfxxgknb/20200131152501262.html.
[3] 国家药品监督管理局.2018年政府信息公开工作年度报告[EB/OL].(2019-03-29)[2021-09-07].https://www.nmpa.gov.cn/newzwgk/zfxxgknb/20190329153101648.html.
[4] 申杨.以信息化引领药品监管现代化[N].中国医药报,2021-08-30(001).
[5] 王鑫,甄橙.美国药品监管法规百年历程及对中国的启示[J].中国新药杂志,2016,25(8):849-854.
[6] 王晓,杨牧,王璐,等.欧盟与中国药品法律法规及检查体系对比分析[J].中国药业,2020,29(10):60-64.
[7] 孟八一.FDA药物监管权力结构简析[J].中国食品药品监管,2019(7):46-55.
[8] National Archives.About Laws[EB/OL].(2017-12-28)[2021-08-26].https://www.archives.gov/federal-register/laws.
[9] FDA.Laws Enforced by FDA[EB/OL].(2018-03-29)[2021-09-02].https://www.fda.gov/regulatory-information/laws-enforced-fda.
[10] FDA.Federal Food,Drug,and Cosmetic Act(FD&C Act)[EB/OL].(2018-03-29)[2021-09-06].https://www.fda.gov/regulatory-information/laws-enforced-fda/federalfood-drug-and-cosmetic-act-fdc-act.
[11] FDA.Selected Amendments to the FD&C Act[EB/OL].(2018-03-29)[2021-09-06].https://www.fda.gov/regulatory-information/laws-enforced-fda/selectedamendments-fdc-act.
[12] National Archives and Records Administration.A Brief History Commemorating the 70th Anniversary of the Publication of the First Issue of the Federal Register March 14,1936[EB/OL].(2014-06-11)[2021-08-29].https://www.archives.gov/files/federal-register/the-federalregister/history.pdf.
[13] 王越,周良彬,王悦,等.美国和日本医疗器械数据库系统构建思路探析[J].中国药事,2019,33(10):1181-1186.
[14] FDA.Fact Sheet:FDA Good Guidance Practices[EB/OL].(2019-12-04)[2021-08-29].https://www.fda.gov/about-fda/transparency-initiative/fact-sheet-fda-goodguidance-practices.
[15] FDA.Guidances(Drugs)[EB/OL].(2021-09-03)[2021-09-07].https://www.fda.gov/drugs/guidancecompliance-regulatory-information/guidances-drugs.
[16] 新浪医药新闻.国内各类医药数据库的发展现状[EB/OL].(2017-02-22)[2020-08-12].https://med.sina.com/article_detail_103_2_20740.html.
