Electronic Common Technical Document (eCTD)

 

Important Notices

• Errata to the eCTD Module 1 Update (added 04/2013)

• FDA has published a new document, Specifications for File Format Types Using eCTD Specifications (PDF) (added 04/2013)

• FDA has completed testing and will deploy upgrades to its validation software in April 2013 (added 02/2013)

• Draft eCTD Guidance - Not for implementation - Public comment period closes March 4, 2013 (added 01/2013)
• Submission of Advertising, and Promotional Labeling to CDER/OPDP (added 04/2012)
• Submission of Periodic reports to the eCTD - avoid incorrect submission of ICSRs (added 01/2012)

• eCTD Basics and Getting Started

• Submit a Sample eCTD or Standardized Data Sample to the FDA
   

eCTD Documentation and Resources:

Below is a listing of Websites, Guidance documents and Specifications related to eCTD.

Category	Title	Date
CDER Pre-assigned Number	Request a CDER Pre-assigned Application Number for a Planned eCTD Submission	N/A
CBER Pre-assigned Number	Request a CBER Pre-assigned Application Number for a Planned eCTD Submission	N/A
eCTD Guidance	Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications	06/08
ISS/ISE Guidance	Final Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document (PDF - 98KB)	04/09
eCTD CTOC	FDA eCTD Table of Contents Headings and Hierarchy	07/05
M1 Specifications	eCTD Backbone Files Specification for Module 1	12/06
M1 New Specifications	eCTD Module 1 - Updated Module 1 documents and supporting files - not for implementation	02/13
eCTD Specifications	eCTD Backbone File Specification for Modules 2 through 5 3.2.2	07/08
STF Specification	The eCTD Backbone File Specification for Study Tagging Files 2.6.1	06/08
Study Data Specifications	Study Data Specifications	07/12
Validation Specifications	eCTD Validation Specifications Website	12/11
PDF Specifications	Portable Document Format Specifications	01/12
Transmission Specifications	Transmission Specifications	07/12
File Format Specifications	Specifications for File Format Types Using eCTD Specifications	04/13
Gateway	Electronic Submissions Gateway (ESG)	N/A

 

eCTD Supportive Files

eCTD Supportive Files	Version	File Name	MD5 Checksum	Support Began	Support Ends
ICH eCTD DTD	3.2	ich-ectd-3-2.dtd	1d6f631cc6b6357f0f4fe378e5f79a27	11/2003
ICH-STF DTD	2.2	ich-stf-v2-2.dtd	0972c10a4dadf3df5d2f41b2026a4a5c	8/2003
US Regional DTD	2.01	us-regional-v2-01.dtd	9d09aa5ffdb44368416e287f9b0ddeeb	8/2003
US Regional Stylesheet	1.1	us-regional.xsl	b3bdeb93158b2a30faca4d943b89fba4	9/2003
ICH eCTD Stylesheet	2.0	ectd-2-0.xsl	3a07a202455e954a2eb203c5bb443f77	11/2004
ICH STF Stylesheet	2-2a	ich-stf-stylesheet-2-2a.xsl	7af15705b92a21ac1a19527cfc504245	5/2007
Valid Values xml	2.2	valid-values.xml	664f584d0631db0414e8789e2a06613b	8/2008
Valid Values xml	3.0	valid-values.xml	301aaeb6b0fac8873a668fb4cbade517	4/30/2013

If you have questions for CDER, please contact CDER ESUB at esub@fda.hhs.gov.

If you have questions for CBER, please contact CBER ESUB at esubprep@fda.hhs.gov.