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eCTD indexer

The eCTD indexer is a free and open source program to generate the xml backbones - eu-regional.xml and index.xml required for submission of registration dossiers in the eCTD format. Use of this program requires knowledge of the guidelines linked below and a (very) basic understanding of XML.

The program, code and instructions are hosted on SourceForge.net. Download from there. The program is written in C# and requires .NET Framework 3.5 or mono to run.

Uses eCTD specification v. 3.2 and EU Module 1 version 1.4 as of 15 November 2009.

Copyright 2007-2013 Ymir Vesteinsson, ymir@ectd.is. Any feedback is welcome.

eCTD viewer

The eCTD viewer is a free and open source program that is run from the command line. It is written in Python and requires Python 3 to run. Last updated 2014-02-04.
Download the program and instructions here.

Copyright 2013 Ymir Vesteinsson, ymir@ectd.is.

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GPLv3

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Links to relevant guidelines:

eCTD Specification and Related Files: http://estri.ich.org/eCTD/index.htm/
Notice to applicants - current EU Module 1, electronic application form: http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm
EU eSubmission guidelines: http://esubmission.emea.europa.eu/index.htm
Heads of Medicines Agencies - Procedural Guidance for eSubmissions: http://www.hma.eu/277.html