EMA releases updated EU regional Q&A and Electronic Submission Specifications & Guidances Change Request Document

The European Medicines Agency (EMA) has released an updated version (Version 1.24) of the "EU Region Question & Answer and Electronic Submission Specifications & Guidances Change Request Document".

The document has undergone some major revisions including but not limited to the following changes:

• Removed Tab sheets: Q&A #10, Q&A #12
• New Tab sheet "Calendar of Meetings"
• Question & Answers: Q&A #1 - 9 and #11 - 22 were removed; new #Q&A 25 - 29 were added
• Change requests: The status of existing change requests was updated, 11 new change requests were added, eight old change requests were removed as four change requests were closed (CR-20070928-01, CR-20080703, CR-20080703-01, CR-20091016) and four were rejected (CR-20071001-01, CR-20071009-01, CR-20091015, CR-20100128). Change request QA-20071022-01 has been included in the list of duplicate change request but is still listed as active.
• Eight new entries were added to the change requests implemented in in EU M1 v1.4

Most notable new Q&A are:

• Q&A #25: Further guidance regarding usage of the "related sequence" element
• Q&A #26: Further guidance regarding baseline submissions is given, in particular the usage of multiple "reformat" submission types during an eCTD lifecycle
• Q&A #27 defines submission type "withdrawal" as applicable only in case of the withdrawal of the corresponding marketing authorisation application. It should not be used for the withdrawal of individual variations (in this case the corresponding submission type would be "supplemental-info").

Most notable new change requests are:

• Request to define and document the procedure applicable in case of technically invalid eCTDs (CR-20100805)
• Request to handle the provision of updated product information files for some milestones in the Centralized Procedure outside the eCTD to lower administrative burden (similar to MRP/DCP; CR-20100920, accepted)
• Request to remove RTF as an acceptable file format (CR-20101020, accepted)
• Request to define the submission type for "Letter of Undertaking" submissions (CR-20101022-02, accepted)
• Request to further define supportive documentation in case of variation sequences (CR-20101122, accepted)

 The new Q&A and Change Request list is available for download in MS Excel format from the Agency`s eSubmission website (see link at the bottom of this article).

[Source EMA eSubmission website]

Related News:

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

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