按照FDA eMDR最终规则(Federal Register : Medical Device Reporting: Electronic Submission Requirements),要求器械制造商和进口商向FDA提交单个医疗器械不良事件的强制性报告,又名医疗器械报告(MDR),以电子版的形式交给FDA,且该电子版允许FDA处理、审查和存档,继续以FDA FORM 3500A表格形式提交报告。 MDR法规(21 CFR ...
Type选eCTD。（https://www.fda.gov/drugs/forms-submission-requirements/electronic-regulatory-submission...
Submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless exempted from the electronic submission requirements. 本指南执行的是FDCA第745A(a)条款的电子申报要求,其适用于向CDER...
该模块下Forms & Submission Requirements(表格和递交要求)项下,包含Drug Master Files (DMFs) 药品主文件(DMFs)及Electronic Regulatory Submission and Review(电子法规提交和审查),点击Drug Master Files (DMFs) 药品主文件(DMFs),进入如下左侧界面,点击List of DMFs,进入如下右侧界面,可以查看DMF清单,每季度更新一次...
Submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless exempted from the electronic submission requirements. 本指南执行的是 FDCA 第 745A(a) 条款的电子申报要求,其适用于...
The Electronic Submissions page provides more information regarding the test submission process. FDA希望与计划使用eCTD规范提供提交并帮助顺利完成流程的人员密切合作。机构还提供了提交标准化数据集样本进行验证的流程。样本提交只是测试,不被视为正式提交。FDA审查员在任何时候都不会对其进行审查。“电子提交”页面...
Electronic Submissions Revision 4 2017年4月 电子提交 第四次修订 相关文件 与此指南相关的技术规范以独立文件的形式提供并定期更新。本指南中引用的文件在本文结尾处给出。以电子形式提交所需的所有相关文件和支持性文件,请参阅以下eCTD网页 /Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmiss...
为进一步促进美国FDA和加拿大卫生部的合作,双方正致力于实现一种通用的电子递交通道(electronic submissions gateway, ESG),使制药公司能够同时向美国FDA和加拿大卫生部提交大型电子文档。 此次合作只是双方正在计划中的一系列联合行动计划之一,作为美国-加拿大监管合作委员会(RCC)工作的一部分,此次合作旨在增加两家药品和医疗...
在本指南引用到的更多技术标准文件,欲获得所需技术支持文件如格式表和验证值)的全部列表(来进行eCTD格式提交,参见eCTD网页http://www./Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm. E.预提交注意事项 第一次电子提交申请之前,必须先与相关部门取得联系获得一个预分配...
FDA issued a proposed rule that would amend 21 CFR part 207 to require electronic submission of drug establishment registration and drug listing information, and that included proposals such as certain changes to the National Drug Code (NDC) system and requirements regarding placement of the appropria...