Electronic Common Technical Document (eCTD) Module 1
- An Addendum has been added to the eCTD Backbone Files Specification for Module 1 Version 2.3 [PDF] (7/1/2014) (see "eCTD Specifications" below)
- An update to implementation plans is being provided with updated files [PDF] (2/7/2014)
- Prior eCTD M1 Public Meeting Information - Agenda, Presentations and Audio/Video Recordings (9/18/2012)
IMPORTANT NOTE: NOT FOR IMPLEMENTATION AT THIS TIME
The documents and files provided below are for planning and preparation purposes only. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.3 by 4th Quarter 2014, and will give 30 days' advance notice to industry.
This information supports FDA’s major updates to module 1 of the eCTD. Since adoption of the eCTD standard, it has become necessary to update the administrative portion of the eCTD (Module 1) to reflect regulatory changes, to provide clarification of business rules for submission processing and review, to refine the characterization of promotional marketing and advertising material, and to facilitate automated processing of submissions. The Specifications and supporting technical files are provided below.
- Comprehensive Table of Contents Headings and Hierarchy Version 2.3 [PDF] (2/7/2014)
- The eCTD Backbone Files Specification for Module 1 Version 2.3 [PDF] (2/7/2014)
- Specifications for eCTD Validation Criteria 3.1 [PDF] (2/7/2014)
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Meeting Agenda [PDF - 18KB]
Q&A Session: https://collaboration.fda.gov/p76535869/