CTD Common Technical Document CTD的英文全称为Common Technical Document，是人用药品注册技术要求国际协调会（ICH）撰写的通用技术文件。起草这个文件的目的是为了规范各个地区的注册申请文件，提高注册机构的评审效率，节约有限的药品审评时间和资源，加强同申请人之间的沟通与交流，同时更有助于实现各注册机构之间注册...
CommonTechnicalDocument(CTD) 33 com Common Technical Document (CTD) Harmonised format of docu-mentation to be submitted for marketing applications in the three ICH-regions; Module 1 contains the administrative and prescribing information documents specific to each regional regulatory agency; Module 2 cont...
description should be provided; Module 3 provides the chemical-pharmaceutical and biological information for both chemically active substances and biological medicinal products; Module 4 and 5 contain the nonclinical and clinical study reports, respectively; each Module is preceded by a table of contents...
M4 (R4): Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use M4(R4):人用药物注册通用技术文档的组织(中文版:征求意见稿) 阶段5 2016.6.15 有 M4 Implementation Working Group Questions & Answers (R3) M4执行工作组问答(R3)(中文版:征求意见稿) 阶段5 20...
网络释义 1. 通用技术文件 术语集 ... ... (Case Report Form) → 病例报告表 (Common Technical Document)通用技术文件(Data Management) … www.epscn-hq.cn|基于12个网页 2. 共同技术文件 制剂如何通过TGA现场检查或认证 ... •共同技术文件(Common Technical Document) •严重缺陷 Critical deficiency...
USFDA Module 1 Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.1 美国FDA 模块1 eCTD v4.0 实施指南 v1.1 2017.2.20 This document only includes the specification information for eCTD v4.0 Modules 2 – 5 submission contents which are shared across all regions. The eCTD v4....
3 Further CMIS revisions with the same major revision number will be backwards specification-compatible to 4 CMIS 5.1 allowing interworking in cases when host and module implement different CMIS revisions1. 5 6 Revision History (Published Versions) 7 Rev 3.0 August 17, 2018 8 - Initial public ...
Cisco announces the end-of-sale and end-of-life dates for the Cisco Common Services Platform Collector (CSPC) M5 for BCS. The last day to order the affected product(s) is October 30, 2023. Customers with active service contracts will continue to re...
Refer to Cisco Technical Tips Conventions for more information on document conventions. %C6KPWR-SP-4-UNSUPPORTED: unsupported module in slot [num], power not allowed: [chars] Problem The switch reports this error message: C6KPWR-SP-4-UNSUPPORTED: unsupported module in slot [num], power...
DocumentRoutingPrinterEntity EFDocEmailAccountConfigurationEntity EcoResProductCDSCategoryAssignmentV2Entity EmailTemplateMessageSystemEntity EmailTemplateSystemEntity ExchangeRateEntity ExchangeRateTypeEntity GBTParametersEntity MeasurementCategoryEnabledModuleEntity Measuremen...