EU Electronic Submission Specifications & Guidances Change Request Documents updated

A new version of the EU Telematics EU eCTD Change Request/Q&A Tracking Table has been released by TIGes.  The new version number is presumably 1.26 and has the official version date "June 2011".

Several updates regarding Change Requests (CRs) were included since the last publication on May this year (see our related News article); all recent updates are color-coded in the corresponding Excel sheet for convenience. The update consists in total of

• EU Telematics EU eCTD Change Request/Q&A Tracking Table
• The new agreed Change Request Process (June 2011)
• The Electronic Submission Change Request Q&A form (June 2011)

All documents are available from the eSubmission website of the European Medicines Agency (see link at the bottom of this article).

In Verbindung stehende Artikel:

 Updated EU Region Q&A and Electronic Submission Specifications & Guidances Change Request Document released - 13.05.2011 15:16

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