Useful links

General information on eSubmissions

Basic explanation of eSubmissions at the EMA
http://esubmission.ema.europa.eu/

 

Information on the eCTD specification by the ICH

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human (ICH)

http://www.ich.org/

ICH Electronic Common Technical Document (eCTD)
http://estri.ich.org/

ICH Specification v.3.2.2 (Modules 2-5)
http://estri.ich.org/eCTD/index.htm

ICH ETICS M2 Project
http://www.etics.us/

 

Free validation tools

Validation tools for the Swiss eCTD specification can be obtained from the following software suppliers:

EXTEDO GmbH (http://www.extedo.com/)
Download link: https://www.extedo.com/products/submission-validation/eursvalidator/

LORENZ Life Sciences (http://www.lorenz.cc/)

Download link: www.lorenz.cc/swiss