CTD格式目录 ICH CTD-Table of ContentTable of Content ofICHCTD Module 1: Administrative Information and Prescribing Information 1.1Table of Contents of the Submission Including Module 1 1.2 Documents Specific to Each Region (for example, application forms, prescribing information) Module 2: Common ...
CTD是Common Technical Document的缩写,即药品的质量、安全和有效性方面的通用文件,共分为5个模块: Module1(M1)是各个地区行政方面的文件; Module2(M2)是药品质量、非临床研究以及临床研究方面的总结和概述; Module3(M3)是药品质量方面的文件; Module4(M4)是非临床试验方面的文件; Module5(M5)是药品临床试验方面...
EDMFcomplicationinCTDformat:a)Module3.2.S.DrugSubstanceb)Module2.3QualityOverallSummaryCEPProcedureversustheDMFProcedureFilingstrategiesinEUcountriesCertificationofsuitabilitytothemonographsoftheEuropeanPharmacopoeiaProcedure,SubmissionoftheDossier,ContentoftheDossier/ExpertReport,Assessment,Timetable,Follow-up Module3.2...
Module 1 Table of Content 1.0 Cover Letter 1.1 Comprehensive Table of Contents 1.2 Application Form 1.3 Product Information 1.3.1 SPC, Labelling and Package Leaflet SPC, 1.3.2 Mock-up 1.3.3 Specimen 1.3.4 Consultation with Target Patient Groups 模块1 内容简介 封面信 内容简介 申请格式 产品信息...
Content 文件金字塔CTD的概念和规则CTD金字塔CTD的应用 举例：ANDA与SFDACTD的对照（ANDA）文件金字塔 提交文件 注册申报 审批 总结文件综合报告 原始数据和记录，基础资料MasterFiles GXP执行 现场检查 文件金字塔 按照文件的生成时期和来源，将药品开发过程中产生的文件归纳成三个层次：在...
Objective: The present work was an attempt to understand the Australia (AU) and South Africa (ZA) specific additional data requirement of Chemistry, Manufacturing and Control (CMC) in order to build Module 3 dossier and ensuring timely approval of generic product in Z...
撰写好的Word文档要进行两个检查:一为内容检查(Content QC),二为格式检查(Format QC)。 内容检查不是指技术内容的检查,而是指内容表达的检查,比如,数字和单位叠加的表达( three 5 L flasks into four 3 L flasks;3,4,5 kg),缩略语和大小写是否规范,日期时间的格式是否统一,上下角标,用词规范,拼写错误,以及...
Details on how to prepare a submission dossier based on the CTD format including information on the content of Module I are included in the revision of the Notice to Applicants. ? EMEA 2006 2 COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY QUALITY OVERALL...
Question 4a: CTD-format for Variations: As since 1 July 2003, all variation applications must be submitted using the EU- CTD format, can you specify the content of Module 1 and 2 for Type II variations? Answer: It is suggested to present the documentation for variation applications as ...
Module1(M1)是各个地区行政方面的文件; Module2(M2)是药品质量、非临床研究以及临床研究方面的总结和概述; Module3(M3)是药品质量方面的文件; Module4(M4)是非临床试验方面的文件; Module5(M5)是药品临床试验方面的文件。 eCTD即是电子化的CTD注册申报方式,相对于传统的纸质递交,eCTD电子递交更便捷、更环保。对于...