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eCTD indexer

The eCTD indexer is a free and open source (GPL v3) 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.

Download the program and its instructions here:
EU Module 1 specification v. 3.0.1, eCTD specification v. 3.2: 2016-08-27
EU Module 1 specification v. 2.0, eCTD specification v. 3.2: 2016-02-16

The code (C#) is hosted on Github.

Copyright 2007-2016 Ymir Vesteinsson, ymir@ectd.is. Any feedback is welcome.

eCTD viewer

A Python script to list the documents valid in the current dossier. It can also be used to automatically generate a new baseline eCTD sequence.
No graphic user interface is provided, run from the command line. Requires Python v. 3 to run. Last updated 2015-07-16.
Download the program and instructions here.

Copyright 2013-2015 Ymir Vesteinsson, ymir@ectd.is.

Sponsored by:

Pharmaceutical Regulatory Affairs

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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.ema.europa.eu/
Heads of Medicines Agencies - Procedural Guidance for eSubmissions: http://www.hma.eu/277.html