EU eCTD Change Request/Q&A tracking table updated by TIGes

The Telematics Implementation Group - electronic submissions (TIGes) has released another updated version 1.30 of the EU eCTD Change Request/Q&A Tracking Table. 

Compared to the last version 1.29 from April 2012 (see "Related News" at the bottom of this article) the following changes were made:

• New Q&A 38 has been added to clarify acceptable versions for PDF files used in applications submitted in eCTD or NeeS format.
• New Change Requests added:
  • CR 20120302, seeking clarification whether "track change" version of the Risk Management Plan (RMP) could be provided outside the eCTD / NeeS structure as "workingdocument"
  • CR 20120308 requesting to update the current ASMF eCTD guidance with respect to the filename - prefixes "ap-" and "rp-" currently recommended to separate files belonging to the applicants part (ap) from those belonging to the restricted part (rp). To be inline with ICH file name requirements, suffixes should be used in the future.
  • CR 20120413 to allow for PDF versions 1.4, 1.5, 1.6, and 1.7 (see also the new Q&A 38 above)
• CR 20120209 has been accepted since last version
• CRs CR 20110506, CR 20110725, 20120210-01, 20120210-02, 20120301, and 20120326have been closed

The new version 1.30 of the EU eCTD Change Request/Q&A Tracking Table can be downloaded in MS Excel format from the TIGes / eSubmission website.

[Source: TIGes / eSubmission website]

Related News:

 EU eCTD Change Request/Q&A tracking table updated by TIGes - 14.05.2012 15:21

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