FDA的eCTD模块1框架文件规范 2018.10.18 英文.pdfVIP

The eCTD Backbone Files Specification for Module 1 The eCTD BACKBONE FILES SPECIFICATION FOR MODULE 1 Revision History Date Version Summary of Changes 2003-08-13 1.0 Original version 2004-03-01 1.1 Clarifications to the original version 2006-04-13 1.2 Change to Related Sequence Example 2006-12-13 1.3 Change to XML coding for a supplement to an original application related sequence example 2012-06-01 2.0 Change to reflect major modifications to Module 1 (admin) and the use of attributes (Summary of Changes in Appendix 2) 2012-11-01 2.1 Changes include updating the DTD version references and includes a copy of the updated DTD version 3.1 in Appendix I (Summary of Changes in Appendix 2) 2013-08-23 2.2 Changes include two additional attributes for m., updating the DTD version references and updating the copy of the DTD in Appendix I (Summary of Changes in Appendix 2) 2014-02-07 2.3 Modified the heading for (Summary of Changes in Appendix 2) 2018-10-18 2.4 Changes include new eCTD submission type: REMS Supplement; updated hyperlinks which were no longer working Version 2.4 The eCTD Backbone Files Specification for Module 1 TABLE OF CONTENTS TABLE OF CONTENTS 1 INTRODUCTION 1 I. USE OF ATTRIBUTES 1 II. START OF THE MODULE 1 eCTD BACKBONE FILE 2 III. ADMIN ELEMENTS 3 A. Applicant-info Element 3 1. ID Element 3 2. Company-name Element 3 3. Submission-description Element 4 4. Applicant-contacts Element 4 B.