A new version of the "EU Region Question & Answer and Electronic Submission Specifications & Guidances Change Request Document" has been released today by the European Medicines Agency (EMA). The new version 1.25.4 has the official version date "March 2011". Several updates were included as agreed on meetings of the TIGes Joint Group and the eSubmission Change Control Board. Updates include the addition of new Change Requests (CRs), incorporation of Revisions and the moving of "Rejected" and "Closed" CRs to the corresponding spreadsheets.
For More Information Please click : Exalon Updated EU Region Q&A
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