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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.

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