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.

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, 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,

Sponsored by:

Pharmaceutical Regulatory Affairs


Links to relevant guidelines:

eCTD Specification and Related Files:
Notice to applicants - current EU Module 1, electronic application form:
EU eSubmission guidelines:
Heads of Medicines Agencies - Procedural Guidance for eSubmissions: