New draft version of technical EU eCTD/NeeS validation criteria released for consultation

The Telematics Implementation Group for electronic submissions (TIGes) has released new draft versions for public consultation of the EU technical validation criteria for eCTD (draft version 3.4) and NeeS (draft version 2.3). 

The draft versions contain the following proposed changes:

eCTD technical validation criteria, draft 3.4

• The checksums for the ICH DTD and EU M1 DTD has been established as final single overall check for acceptable versions (criteria 1.3 and 3.3). Former criteria 1.3 and 1.4 have been removed as a consequence.
• New rule: following eCTD sequences must use equal versions of the DTDs or newer versions of the DTDs, a return to earlier versions of the DTDs in a later lifecycle sequence is not accepted ("do not go back" - criterion). Implemented for ICH DTD and EU M1 DTD (new criteria 1.4, 3.4)
• New rule added to address the above-mentioned new criteria 1.4 and 3.4 also for eCTD sequences submitted  out of order (new criteria 1.5, 3.5)
• Criteria 2.3 and 2.4 merged into new 2.3 to define acceptable ICH style sheet versions to match the current acceptable DTD. Old 2.4 removed. Similar simplifications included for the EU M1 style sheet (6.3 and 6.4), the EU M1 leaf MOD file (4.3 and 4.4) and the EU M1 envelope MOD file (5.3 and 5.4)
• Reference to the ICH DTD and style sheet in the /XXXX/util/dtd folder has been added as new rule to address change request CR 20110513-03 (new criteria 7.5 and 7.6)
• Reference to the EU Regional DTD and style sheet in the /XXXX/util/dtd folder has been added as new rule to address change request CR 20110513-04 (new criteria 9.5 and 9.6)
• For criteria 11.4, 11.5, and 11.6 the term "cross reference" has been placed before "xlink:href" for clarification purposes. Cross references must not contain illegal characters.
• Criterion 13.3 defines now that the sequence folder name must match the sequence number in each envelope in eu-regional.xml
• Requirements for envelope attributes in criteria 14.2 and 14.BP3 have been clarified.
• Comment regarding RTF in criterion 15.1 has been removed. RTF is no longer accepted as file format.
• Additional clarification added regarding valid characters in criteria 15.6 and 15.7
• A variable extension has been included in the acceptable filename for the eCTD tracking table for MRP/DCP. File is named "common-cover-tracking-var.pdf" (criterion 15.12)
• PDF version 1.7 has been added as comment to criterion 16.1 and as a rule to criterion 16.BP1.
• New rule 16.4 added to test presence of corrupted files. All files must be in compliance to the requirements of the ISO 32000-1 specification
• New rule 16.BP11 to check that the bookmark pane is not visible in case no bookmarks are present to address change request 20110725

NeeS technical validation criteria, draft 2.3

• Module ToCs are now only allowed to have hyperlinks to documents within the corresponding Module and not to documents within other Modules (e.g. m1-toc.pdf must only point to documents residing within Module 1; criterion 1.6)
• New rule 1.8 added to check that hyperlinks in ToC files do not contain “../” in the file path in order to avoid broken links when moving the NeeS to a different location or changing the four-digit sequence submission folder name
• RTF removed from the comments to rule 2.1. RTF files are no longer accepted
• PDF version 1.7 has been added as comment to criterion 3.1 and as a rule to criterion 3.BP1
• New rule 3.5 added to test presence of corrupted files. All files must be in compliance to the requirements of the ISO 32000-1 specification
• Removed comment "There should be no hyperlinks to destinations outside the NeeS" from criteria 3.BP2 and 3.BP3
• New rule 3.BP10 to check that the bookmark pane is not visible in case no bookmarks are present to address change request 20110725

The new draft eCTD technical validation criteria 3.4 and NeeS technical validation criteria 2.3 are available for download from the TIGes website. Major concerns or comments should be addressed to the Chair of the TIGes Harmonisation group, Karin Grondahl by 13th February close of business. According to TIGes, the new version is planned to be effective from 01 June 2012.

[Source EMA/TIGes eSubmission website]

In Verbindung stehende Artikel:

 EU eCTD and NeeS validation criteria updated by TIGes - 18.03.2011 16:18

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