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.

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: 10/23/2014
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