Drugs

Electronic Common Technical Document (eCTD) Module 1

IMPORTANT INFORMATION

IMPORTANT NOTE: NOT FOR IMPLEMENTATION AT THIS TIME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 1st Quarter 2015, 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. 

eCTD Specifications

DTD and Stylesheet Version File Name MD5 Checksum

US Regional DTD

3.3

us-regional-v3-3.dtd

BEA39BE6D3A1716262A30A87657BCE2D

US Regional Stylesheet

2.2

us-regional.xsl

512D2CA77B051A815D9CD73A151615F9

Attribute Lists Version File Name MD5 Checksum

applicant-contact-type

1.2

applicant-contact-type.xml

679F73D149530F16972EA85066DE7E50

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

1.2

promotional-material-doc-type.xml

85A2A790D7F4E3C504CBAE2EB3FBC767

promotional-material-type

1.2

promotional-material-type.xml

66C0A417BD97F5D5C3FB8F14783F42B7


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.

 

Page Last Updated: 08/28/2014
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