eCTD format mandatory from 2010 at the EMEA
This article was originally published in SRA
Executive Summary
The European Medicines Agency has added a new milestone to its plans to implement electronic-only marketing authorisation applications from drug companies in a standardised format under the centralised procedure1. From 1 January 2010, use of the electronic common technical document (eCTD) format will be mandatory for all new and existing submissions and for all submission types.