The project is based on eCTD-indexer of Ymir Vesteinsson (https://github.com/dayzero/ectd_indexer). With eCTD-indexer you are able to create and modify eCTD dossiers.
For more information about the EU Module 1 please have a look at http://esubmission.ema.europa.eu/eumodule1/
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
- eCTD EU Validation Criteria v7 http://esubmission.ema.europa.eu/tiges/docs/eCTD%20EU%20Validation%20Criteria%20v7.1_Feb-2018.xlsx
- Release Notes Validation Criteria v7 http://esubmission.ema.europa.eu/ectd/Release%20Notes%20for%20eCTD%20Validation%20Criteria%20v7%201_hv-20180302.pdf
- eCTD EU Validation Criteria v6 http://esubmission.ema.europa.eu/tiges/docs/eCTD%20EU%20Validation%20Criteria%20v6%201_March%202016-Final.xlsx
eCTD-indexer is free software: you can redistribute it and/or modify it under the terms of the GNU General Public License as published by the Free Software Foundation, either version 3 of the License, or (at your option) any later version.
The free Iconset "Oxygen" is used: http://www.iconarchive.com/show/oxygen-icons-by-oxygen-icons.org.html . This Iconset is made under the terms of the GNU Lesser General Public License: https://en.wikipedia.org/wiki/GNU_Lesser_General_Public_License The free Iconset "Iconset: 3D Vol.2 Icons by La Glanz Studio" is also used http://www.iconarchive.com/show/3d-vol2-icons-by-3dlb.html This set of Icons is Freeware.