CommonTechnicalDocument(CTD)下载文档原格式pdf原格式共1页 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 ...
通用 技術文件 (Common Technical Document, 以下簡稱為 CTD) 為一通用 格式, 將品質、 安全、有效之資料所須呈現之方式作系統性之編排。 其主要包含五個文件模組: 模組一 (Module 1)包含行政及處方資訊, 而且必須含括各區域或國家特有之文件內... 文档格式:PDF | 页数:5 | 浏览次数:88 | 上传日期:2012...
Common Technical Document (CTD)Harmonised format of documentation 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 contains the quality overall summary, the ...
M4 (R4): Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human UseM4(R4):人用药物注册通用技术文档的组织(中文版:征求意见稿) M4 (R4): Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use M4(R4):人用药物注册...
Find out about Software that Simplifies the Submission of a Common Technical Document Format in Electronic Format
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TheCommon Technical Documentfor the registration of pharmaceuticals for human use: Quality – M4Q(R1). It is particularly relevant to the preparation and organisation of the contents of Sections 3.2.S.2.2 –3.2.S.2.6 of Module 3 of theCommon Technical Document(ICH M4Q). ...
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...
Common Technical Document (CTD)Chapter pp 33 Cite this chapter Dictionary of Pharmaceutical Medicine Gerhard Nahler 72 Accesses Abstract Harmonised format of documentation to be submitted for marketing applications in the three ICH-regions; Module 1 contains the administrative and prescribing information ...
Electronic Common Technical Document Specification V3.2.2 电子通用技术文件规范 V3.2.2 2008.7.16 Introduction The ICH M4 Expert Working Group (EWG) has defined the Common Technical Document (CTD). The ICH M2 EWG has defined, in the current document, the specification for the Electronic Common Tec...