Drugs

Electronic Common Technical Document (eCTD)

Important Notices


eCTD Documentation and Resources:

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

CategoryTitleDate

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eCTD Module 1 Webpage - Updated Module 1 documents and supporting files - not for implementation

02/14

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

Study Data Standards Resources

07/12

Validation Specifications

eCTD Validation Specifications Webpage

02/14

PDF Specifications

Portable Document Format Specifications

09/14

Transmission Specifications

Transmission Specifications

07/12

File Format Specifications

Specifications for File Format Types Using eCTD Specifications

04/13

ICH Document

eCTD IWG Question and Answer Specification Change Request Document

2013

ICH Document

Granularity Document - Annex to M4: Organization of the CTD

10/05

Gateway

Electronic Submissions Gateway (ESG)

N/A

Receipt Date Guidance

Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Receipt Dates

02/14

eCTD Supportive Files

eCTD Supportive FilesVersionFile NameMD5 ChecksumSupport BeganSupport 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 xml3.0valid-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.

 

Page Last Updated: 11/05/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.