EU eCTD and NeeS validation criteria updated by TIGes
The EU Telematics Implementation Group for electronic submissions (TIGes) has updated the recently released harmonized validation criteria for eCTD and NeeS (see our related News article).
This new update concerns two further approved Change Requests (CR):
CR-20110214-01: Request to allow for a single PDF file for the Quality Overview Summary (QOS ) in Module 2.3. Files bearing the filename "qos-var.pdf" with var being a variable extension are now tolerated within folder "23-qos".
CR-20110214-02: Request to delete the comment added alongside Check 10.1 (for eCTD) since it is not supported by the check that is described
The initial implementation date of September 01, 2011 for the harmonized validation criteria remains unaffected. All files are available from the European Medicines Agency eSubmission website (see link below).