Electronic Common Technical Document (eCTD) Update Jon Clark ICH M2 Deputy Topic Leader January 21, 2003

Overview Description of eCTD Results of September ICH M2 Meeting Interim M2 Work February ICH M2 Agenda FDA eCTD Progress

eCTD Description Create and Transport eCTDs Electronic Version of Common Technical Document (CTD) Accommodates CTD 2-5 ICH Modules and Regional Module 1 XML Backbone – Table of Contents Maintained by ICH M2 Expert Working Group (EWG)

September M2 Meeting Results eCTD Specification Signed for Step 4 Study Report Specification Posted for Comment – FDA and ICH eCTD Change Control Process Initiated

Interim M2 Work Proofed eCTD Specification Post- September –Harmonize with CTD December Videoconference –Define Questions for Q&A Document –Peer Review Change Control Document –Task M2 Sub-Group on Study Reports

February ICH M2 Agenda Finalize Change Control Document Reach Agreement on Study Report Implementation Finalize Q&A Document Finalize M2 eCTD Style Sheet Address Change Requests Discuss XML Attributes Updates on Regional Implementation

FDA eCTD Progress eCTD Viewer System Project –Version 1 Scheduled for Spring 2003 –Accompanying Guidance FDA Regional Module 1 –Posted on FDA Internet Soon –ICH Partner, PhRMA, piloting sample eCTD Market Research –Review of Commercially Available eCTD Systems

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