13.05.2011

Updated EU Region Q&A and Electronic Submission Specifications & Guidances Change Request Document released

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.

Most notably, a color code has been introduced to highlight changes in the "Change Request" spreadsheet for new, completed and rejected CRs.

Change Requests:

Three new CRs are listed in the "Change Request" sheet, one CR has been completed, one rejected. The completed CR 20091204 addresses the switch from the "parallel national" eCTD Model for MRP/DCP to the "comprehensive Model" (as described in CMDh/084/2008/Rev2, eCTD BGP for MRP/DCP). As announced in our previous News article, the "parallel national" model will no longer be accepted.
Twelve (12) CRs have been closed and are now included as new entries in the "Closed CRs" sheet, whereas two CRs have been added to the list of "Rejected CRs".

Question & Answers:

A draft answer to Question #23 has now been included in the document. The questions deals with lifecycle operations across different CTD sections (e.g, can a leaf to be submitted in Module 4.2.2.5 replace/append/delete a leaf submitted in Module 4.2.2.2 of an earlier Sequence). The general answer is "no". However the document provides a detailed rationale for the answer and also two exceptions where such a lifecycle operation between sections may be allowed. Note that both exceptions are applicable only under very special circumstances.

For details, please be referred to the original "EU Region Question & Answer and Electronic Submission Specifications & Guidances Change Request Document". The document can be downloaded as MS Excel file from the Agency's eSubmission website (see link at the bottom of this article).

[Source: EMA eSubmission website]

Links:

esubmission.ema.europa.eu/doc/EU_Change_Request_QA_Tracking_Table_1.25.4.xls

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