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.
The program and its instructions can be downloaded directly here. The latest version is dated 2016-02-16. The code is hosted on Github. 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 2007-2016 Ymir Vesteinsson, firstname.lastname@example.org. Any feedback is welcome.
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, email@example.com.
Pharmaceutical Regulatory Affairs
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