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The EU Telematics Implementation Group for electronic submissions (TIGes) released new validation criteria for eCTD and NeeS. The first proposal for the new validation criteria was published at the TIGes website of the European Medicines Agency for open consultation in November last year (see related News article here). The updated criteria documents were discussed at the TIGes December meeting following an adoption by January 24.
Release package
The release consists of the following files: Implementation date:
The new validation criteria will come into force 1st of September 2011 and will be used for the technical validation of electronic submissions received from that day by National Competent Authorities and the European Medicines Agency. The old criteria should no longer apply from that day on.
High-Level validation criteria:
The new eCTD and NeeS validation criteria are divided into Pass / Fail (P/F) criteria and Best Practice (BP) criteria. In order to pass validation, all P/F criteria will need to be fulfilled once the new validation criteria are coming into force. Failure to meet BP criteria should be justified in the cover letter or reviewers guide.
Impact:
Further updates of eCTD and NeeS guidance documents and / or specifications are planned as some of the newly introduced criteria are partly contradictory to existing guidance and / or specifications.
Furthermore, two new change requests have been identified by TIGes during the review which are already approved and which will be implemented "at the next available opportunity": - Request to remove RTF as an acceptable file format for eCTD or NeeS submissions (CR-20101020).
- Request to allow the use of hyphens in the variable portion of eCTD and NeeS file names (CR-20101129).
Where to look:
The new eCTD and NeeS validation criteria, the release notes and the implementation information are available for download from the European Medicines Agency eSubmission website (see link below).
[Source: eSubmission website of the European Medicines Agency]
- Related News:
 New version of the "eValidator" released by BfArM - 11.05.2011 10:53- EU eCTD and NeeS validation criteria updated by TIGes - 18.03.2011 16:18
- EU: Proposal of new validation criteria for eCTD and NeeS open consultation - 11.11.2010 15:37
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