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eCTD guidance from EMEA

eCTD guidance from EMEAOver the past week, the European Medicines Agency (EMEA) has updated a couple of documents related to e-submissions:

First off, the Telematics Implementation Group for electronic submission and ICH Implementation (TIGes) has agreed on a final draft of a harmonized guidance document for the submission of eCTD. This document is adopted by all MS represented in the TIGes, and applicants submitting any eCTD submission to any agency for any procedure should follow the recommendations laid out in the document.

As a follow-on, the EU Telematics EU eCTD Change Request/Q&A Tracking Table [Excel file] was updated. The table contains updates resulting from the publication of the harmonized guidance but other assorted changes.

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