Every CTD module, including Module 4, has a strict and unwavering table of contents (only Module 1 will vary somewhat). Module 4 requires the following table of contents: Module 4: Nonclinical Study Reports: 4.1 Table of Contents of Module 4 ...
(Summary of Changes in Section A of Appendix 2) Modified the heading for 1.15.1.5 (Summary of Changes in Section A of Appendix 2) Version 2.3 Table of Contents THE COMPREHENSIVE TABLE OF CONTENTS HEADINGS AND HIERARCHY ... I THE COMPREHENSIVE TABLE OF CONTENTS HEADINGS AND HIERARCHY ... 1 ...
FDA includedincluded*includedincludedincludedincluded MHLW includedincludedincludedincludedincludednotincluded OTC LastUpdateJune13'02 included included notincluded *withtheexceptionofbloodandbloodcomponents 3)OverallTableofContents(ToC)1.1ToCofModule1oroverallToC,includingModule1 2.1ToCoftheCTD(Mod2,3,4,5)...
U.S.DepartmentofHealthandHumanServices FoodandDrugAdministration CenterforDrugEvaluationandResearch(CDER) August2001 ICH TABLEOFCONTENTS BACKGROUND...2 TheCTD...
3)OverallTableofContents 4)NumberingSystem 5)Pagination(underdiscussion) 6)TransitionalArrangements 7)RegionalSpecificities 8)LineExtensions,Variations&Supplements 9)QuestionsabouttheCTD 10)MeetingPlans Issuesaddressed LastUpdateJune13'02 1)ImplementationDatesofCTD ...
3 Organisation of The Common Technical Document Diagrammatic Representation of the Organization of the ICH CTD Common Technical Document Module 1 Regional Administrative Not part of the CTD Information 1 1.1 Submission T of C CTD Table of Contents 2.1 CTD Introduction 2.2 Module 2 Nonclinical Clinical...
Module 1 ? Websites for guidance documents – FDA: Submitting Marketing Applications According to the ICH-CTD Format—General Considerations http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm073308.pdf – FDA: Comprehensive Table of Contents Headings and Hierarchy ...
3) 去中国CDE/NMPA,美国FDA,欧洲EMA和/或日本PDMA官网,简单了解网站基本架构,了解网站可以查询药品批准信息,法规指南等Visit CDE/NMPA/FDA/EMA/PDMA websites to understand the basic structure, at least know that you can search drug approved information and guidelines on the websites;4) 简单了解中国药典...
ComprehensiveTableofContentsHeadingsandHierarchy RevisionHi Module1Administrativeinformation 7.7Forms 1.1.1Application form:FDAform1571 1.1.2Application form:FDAform356h 1.1.3Userfeecoversheet:FDAform3397 1.1.4Annualreporttiansmittal: FDAform2252 1.1,5Advertisements andpromotional labelingtransmittal: FDA form22...
Table of Contents, Sections, Tables, Figures, References, and Appendices Embedded Fonts Consistent Headers, Footers, and page orientation Converting PDF documents into MS Word Files with Optical Character Recognition (OCR) Learn more about ourmultilingual desktop publishing (DTP) services. ...