Release Notes ectd Validation Criteria for version 4.0 and 4.1

Transcription

1 Release Notes ectd Validation Criteria for version 4.0 and 4.1 The new major version of the validation criteria will come into force on 1 st December 2012 and will be used for the technical validation for all electronic submissions received from that day to the NCAs and EMA. The current version of the criteria will be withdrawn as of close of business on 30 st November Therefore, it is important that applicants plan their submissions very carefully around this date. The changes in the new major version are specified in table 1 below. It is intended that publication of the new version of criteria six months before the implementation date will allow enough time both for tool vendors to upgrade their software and for industry and authorities to test and implement the revised software before the December deadline. The date for implementation of the new major version is still the 1 st December 2012, even if a minor version (version 4.1) has now been adopted and published, since this minor version only includes some few minor corrections (as specified in table 2). Table 1: Comparison of version 4.0 with former version 3.1 General Changes throughout the document: Files and folders Q&A 1,2 & 2,2 & 3,2 & 4,2 & 5,2 & 6,2 & 7,1 & 8,1 & 9,1 Other Changes: - 1,2 & 2,2 & 3,2 & 4,2 & 5,2 & 6,2 & 7,1 & 8,1 & 9,1 1,3 1,3 & 1,4 1,4-1,5-2,3 2,3 & 2,4 3,3 3,3 & 3,4 3,4-3,5-4,3 4,3 & 4,4 Inserted tab sheet containing information on the use of additional folders in NeeS and ectd submissions full text copied from a new published Q&A on the structure Aligned wording of text with NeeS validation criteria, changed The correct placement is used to The files is placed in the correct folder. Merged criteria to have one overall check for the md5 checksum of the DTD. Moved information in Comments about using an earlier version of the DTD to the new criterion 1.4. Newly added, this check prevents going back to an earlier version of the DTD. Newly added, this check prevents using a newer version of the DTD than used for the subsequent sequence, in case sequences have been submitted out of order. Merged criteria on md5 checksum check for the stylesheet and reworded text. Merged criteria to have one overall check for the md5 checksum of the EU M1 DTD. Moved information in Comments about using an earlier version of the M1 DTD to the new criterion 3.4. Newly added, this check prevents going back to an earlier version of the EU M1 DTD. Newly added, this check prevents using a newer version of the EU M1 DTD than used for the subsequent sequence, in case sequences have been submitted out of order. Merged criteria on md5 checksum check for the eu-leaf.mod file and reworded text.

2 5,3 5,3 & 5,4 6,3 6,3 & 6,4 7,5-7,6-9,5-9, ,7 11,7 13,1 13,1 Merged criteria on md5 checksum check for the euenvelope.mod file and reworded text. Merged criteria on md5 checksum check for the EU M1 stylesheet and reworded text. Newly added as a response to CR , this check is to make sure the reference to the DTD in the index.xml is directed to the DTD provided in the util folder. Added in Comments the applicable path and criteria for this DTD and that a valid reference is configured as a URI ( and Newly added as a response to CR , this check is to make sure the reference to the stylesheet in the index.xml is directed to the stylesheet provided in the util folder. Added in Comments the applicable path and criteria for this stylesheet and that a valid reference is configured as a URI ( and (version 2005 page 22, Newly added as a response to CR , this check is to make sure the reference to the DTD in the eu-regional.xml is directed to the DTD provided in the util folder. Added in Comments the applicable path and criteria for this DTD and that a valid reference is configured as a Universal Resource Identifier (URI) ( and Newly added as a response to CR , this check is to make sure the reference to the stylesheet in the eu-regional.xml is directed to the stylesheet provided in the util folder. Added in Comments the applicable path and criteria for this stylesheet and that a valid reference is configured as a Universal Resource Identifier (URI) ( and reference (hlink:href). Added information at Comments that cross reference should be valid and not contain illegal characters. Indicated that a valid reference is configured as a Universal Resource Identifier (URI) ( and reference (hlink:href). reference (hlink:href) and added explanation in Comments that link is valid when target exists. Included in Comments that it is recommended to use operation attribute new for the tracking table, due to national sequences in MRP/DCP. Changed sequence name to sequence folder name to clarify this check applies to the folder system

3 13,2 13,2 Added folder name to clarify sequence number in folder system is meant in this check 13,3 13,3 Added the wording each to make sure the sequence folder name matches the sequence number in each envelope in the euregional xml. 14,2 - Newly added to also reflect envelope situation for MRP/DCP 14,3 - Newly added to also reflect envelope situation for NP 14,4 14,2 Renumbered and reworded to only apply to leaves with operation attribute new, replace or append. Provided explanation at Comments. 14,BP1 14,BP1 At Comments added reference to EU m1 specification and clarified that the ASMF guidance v1.0 contradicts this criterion, but will be updated in due course and that it is recommended to use the related sequence even in ASMF submissions. 14,BP2 14,BP2 At Comments added reference to EU m1 specification. 14,BP3 - Newly added, this check makes sure that for leaves with operation attribute delete, there is an EU envelope with a matching country attribute value. Included explanation that in case there is a need to remove earlier content that has been erroneously attributed to a particular country without provision of a corresponding envelope entry, this BP error should be ignored. 15,1 15,1 Removed information on RTF from Comments and listed the acceptable file formats. 15,2 15,2 In Comments listed the acceptable file formats. 15,3 15,3 Added in Comments that for counting the total file folder path length the filename is included 15,6 15,6 Added in Comments that this test should only be applied to the file names in the system. For checks on the XML test 11.4 applies. 15,7 15,7 Added in Comments that this test should only be applied to the folder names in the system. For checks on the XML test 11.4 applies. 15,12 15,12 Included comment that the use of the XML version of the tracking table is not acceptable and removed the example on the xml filename. 15.BP1 15.BP1 Removed the need to explain a deviation in the cover letter and explained why files larger than 100MB should be avoided. 15.BP3 15.BP3 In Comments removed the information on hyphens in the variable part of the file name. Clarified that for ASMFs a suffix instead of a prefix to the filename should be used and that the ASMF Guidance will be updated accordingly. Included that the potential presence of STF files in m4 or m5 should not be tested. Explained that it is helpful if also underlying files and folders follow ICH and EU naming guidance. 16,1 16,1 In Comments included PDF versions 1.5, 1.6 & 1.7 following ICH Q&A 71. Added copying the full text into a new document in addition to suggestion on scanning. Added reference to 16.BP1.

4 16,2 16,2 16,3 16,3 16,4-16,5-16.BP1 16.BP2 16.BP3 16.BP1 16.BP2 & 16.BP3 16.BP4 & 16.BP5 Specified in Comments that this test should not be used to test for corrupted files and instead see 16,4. Added module 1,2 as an exception. In Comments provided a list of document restrictions that should be allowed. Newly added as a response to CR , to include allowed security settings for module 1.2 Newly added, to detect corrupted files by opening PDFs in software which is compliant to ISO Included PDF versions 1.5, 1.6 & 1.7 following ICH Q&A 71. Included information on the retrieval of the version information. Indicated only the PDF versions specified are recommended by ICH and explained why this BP test is important. Consolidated the criteria for hyperlinks and bookmarks. Reworded Comments to explain that only links in the same software application are tested. Added clarification on the consequences if this BP is not met. Consolidated the criteria for hyperlinks and bookmarks. Reworded Comments to explain that only links in the same software application are tested. 16.BP4 16.BP6 Added explanation on the intention of this BP test. 16.BP5 16.BP7 Added explanation on the intention of this BP test. 16.BP6 16.BP8 Added explanation on the intention of this BP test. 16.BP7 16.BP9 & Consolidated the criteria for hyperlinks and bookmarks. Added 16.BP10 explanation on the intention of this BP test. 16.BP8 16.BP11 Added explanation on the intention of this BP test. 16.BP09 - Newly added as a response to CR , to cover documents without bookmarks 16.BP10 - Newly added, to make sure all links and bookmarks are configured as specified in ISO :2008. Changes in Description of type of Check : BP Best Practice Removed the need to justify BP criteria not being met in the cover letter/reviewer s guide. * Y -criteria Newly added to explain interpretation of results from tests marked with a Y Changes in Tab sheet on File-folder Structure & Names : Legend for Red Added information that for all folder locations containing file names entirely in red text or files with var components, multiple files are accepted. Use of additional Folders Newly added legend for the indication of when and where additional folders are possible or required. Added reference to new tab sheet Files and Folders Q&A cc-cover-tracking-var.pdf Added example of the tracking table. 123-mockup Added more acceptable formats for the mockup in accordance with the EU M1 ectd Specification m1 util DTD Added var.dtd and var.xls, in accordance with the EU M1 ectd Specification

5 Table 2: Comparison of version 4.1 with former version 4.0 number (Version 4.0) number (Version 4.1) Description of the change Typo corrections: "Y" is delete (was included by mistake) One of the "DTD 1.4" is changed to "DTD 1.4.1" in the comment Changes in Description of type of Check : * Y -criteria Further clarification in the description on how tools are expected to deal with Y -criteria. Changes in Tab sheet on File-folder Structure & Names : Line 396 Added multiple branches possible to the specified folder under (535-rep-effic-safety-stud/indication).