Useful links

General information on eSubmissions

Basic explanation of eSubmissions at the EMA


Information on the eCTD specification by the ICH

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

ICH Electronic Common Technical Document (eCTD)

ICH Specification v.3.2.2 (Modules 2-5)

ICH ETICS M2 Project


Free validation tools

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

Download link:

LORENZ Life Sciences (

Download link: