Drugs
Electronic Common Technical Document (eCTD) Module 1
IMPORTANT INFORMATION
- Errata to eCTD Module 1 Documents and Files (4/2/2013)
- Prior eCTD M1 Public Meeting Information - Agenda, Presentations and Audio/Video Recordings (9/18/2012)
IMPORTANT NOTE: NOT FOR IMPLEMENTATION AT THIS TIME
These final documents and files provided below are for planning and preparation purposes only. FDA will provide notice of its ability to receive submissions based on these specifications 30 days in advance of implementation currently scheduled for 2013.
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.
eCTD Specifications
- Comprehensive Table of Contents Headings and Hierarchy Version 2.1 [PDF - 206KB] (11/1/2012)
- The eCTD Backbone Files Specification for Module 1 Version 2.1 [PDF - 251KB] (11/1/2012)
- Example Submissions using the eCTD Backbone Files Specification for Module 1 Version 1.1 [PDF - 279KB] (11/1/2012)
- Example Submissions using the eCTD Backbone Files Specification for Module 1 Version 1.1 [PDF - 279KB] (11/1/2012)
| DTD and Stylesheet | Version | File Name | MD5 Checksum |
|---|---|---|---|
3.1 | us-regional-v3-1.dtd | 3A2C69556C2303C5E9F238EE425B795B | |
2.1 | us-regional.xsl | 8083889BC53BA3A4344A60D27F9EF8C4 |
| Attribute Lists | Version | File Name | MD5 Checksum |
|---|---|---|---|
1.1 | applicant-contact-type.xml | AA06A4C1AD6147270414BF83C7060362 | |
| telephone-number-type | 1.1 | telephone-number-type.xml | 5C2B76A0495739BDEE637C94466BE87D |
| application-type | 1.1 | application-type.xml | 731C0FBA8803CA5338A753966D7FC32E |
| submission-type | 1.1 | submission-type.xml | 2E12238E2A7524FCE31E6958967677FC |
| submission-sub-type | 1.1 | submission-sub-type.xml | 7A86527AFF3AB859E296324ACD57CBE9 |
| supplement-effective-date-type | 1.1 | supplement-effective-date-type.xml | 27BA6059DA49FC96CD0A91D251B04023 |
| form-type | 1.1 | form-type.xml | D06E0092540B6949859E87E30038A7E1 |
| promotional-material-audience-type | 1.1 | promotional-material-audience-type.xml | 0AFD4994C9A5E46BF32C2C86BA7A7034 |
| promotional-material-doc-type | 1.1 | promotional-material-doc-type.xml | 9A5EDC7CC8E25B12B4AC4A614FC7A08A |
| promotional-material-type | 1.1 | promotional-material-type.xml | A3657F703A412ED4CC1DACF7835C6BC9 |
On 9/18/2012 a Public Meeting on Module 1 Updates took place at FDA's White Oak Campus. Below are links to helpful information from that meeting.
- Meeting Agenda [PDF - 18KB]
Audio/Video Recordings
- Presentations: https://collaboration.fda.gov/p88782361/
Q&A Session: https://collaboration.fda.gov/p76535869/
