13/01/09 - EMEA eCTD implementation strategy

EMEA has announced plans to mandate the use of the Electronic Common Technical Document (eCTD) format for electronic-only submissions in the centralised procedure from 1 January 2010. From July 2009 until 1st January 2010, EMEA will continue to accept non-eCTD electronic-only submissions (eCTD is, however, the recommended format).

In addition EMEA has announced that any non-eCTD electronic submission provided in the context of the Centralised Procedure must also comply with the EMEA’s new specific guidelines for non-eCTD electronic submissions.

The introduction of mandatory eCTD is an extension to the existing EMEA strategy for implementation of electronic-only submissions and eCTD. (source)
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