Criteria Webinar. 13 th July European Update on Validation of ectd & NeeS submissions, July 2012

Transcription

1 EU ectd and NeeS Validation Criteria Webinar TIGes Harmonisation Group 13 th July

2 Presenters of the day from TIGes Harmonisation Group Alastair Nixon (EFPIA) Klaus Menges ges( (DE) Manuela Copier (EFPIA) Mickel Hedemand (DK) Jaspreet Singh (EMA) Karin Gröndahl (SE) 2

3 Why change? Changes in EU specification i (EU m1 v1.4.1) Changes gesat ICH level, ee, need to be reflected ectedin EU Lack of harmonisation between vendors, interpretation of the rules themselves Quality of dossiers received by agencies still needs to improve Desire to automate the validation process 3

4 ectd Criteria Changes These changes also applied to equivalent NeeS criteria if applicable 4

5 DTDs, MOD files and Stylesheets Currently acceptable is now a direct comparison withthe the published checksum References to these from index.xml xml and eu regional regional.xml must go to the location as specified in the DTD/MOD/Stylesheet check itself Uniform Resource Identifiers (URIs) links to DTDs, Stylesheets etc must be URIs (see later slide on hypertext links) 2 new criteria for DTDs checks again preceding and succeeding sequences, to check when sequences are submitted out of order see next slide 5

6 DTD Criterion Scenario 1 Sequence 0004 DTD 1.3 Sequence 0005 DTD 1.3 Sequence 0006 DTD Criterion 1.4 preceding sequence 1.3 = 1.3 Criterion 1.5 succeeding sequence 1.3 < 1.4 6

7 DTD Criterion Scenario 2 Sequence 0004 DTD 1.4 Sequence 0005 DTD 1.3 Sequence 0006 DTD Criterion 1.4 preceding sequence 1.3 not 1.4 Criterion 1.5 succeeding sequence 1.3 < 1.4 7

8 DTD Criterion Scenario 3 Sequence 0003 DTD 1.3 Sequence 0004 national, not in lifecycle Sequence 0005 DTD 1.4 Sequence 0006 DTD Note: Preceding sequence in this case is 0003, the tool should work backwards (or forwards) to the next sequence present Criterion 1.4 preceding sequence Criterion 1.5 succeeding sequence

9 Envelopes Added check for procedure type : if procedure type is 'mutual recognition' or 'decentralised, there must be one or morecountry specific envelopes (not EMEA) Similarly for procedure type is national only one envelope allowed New leaf/envelope consistency rules: Sequences with new/append/replace leaves under country specific elements must have that country in the envelope (pass/fail) Sequences with delete leaves same rule, but BP only to allow for removal of incorrect content 9

10 Files/Folders Acceptable formats removed rtf in line with EU m1 v1.4.1 Valid characters clarification, must be tested on file names themselves, not xlink:hrefs in XML File naming in ASMF dossiers rp and ap now recommended as suffixes in both ectd and NeeS (ASMF Guidance still to be updated, it recommends prefix) Multiple hyphens allowed in var component of name 10

11 Files/Folders Naming Worksheet Additional tab Files and Folders Q&A. Modules 1, 2 & 3 no additional folders beyond specified structure allowed Exception sections m3.2.a and m3.2.r Module 4 additional folders are optional. Module 5 additionalfolders are required for allsections apart from m5.2, m5.3.6 and m5.4. Optionally, additional folders below the specified structure are also allowed. 11

12 Files/Folders Naming Worksheet Examples 0000/m1/eu/10 cover/emea/emea cover.pdf /10 / / 0000/m1/eu/10 cover/emea/addendum/emea coveraddendum.pdf 0000/m4/42 stud rep/421 pharmacol/4211 primpd/studyfolder/report1.pdf p p Folder not allowed 0000/m5/53 clin stud rep/531 rep biopharm stud/5314 bioanalytanalyt met/report1 met/report1.pdfpdf Subfolder mandatory 0000/m5/53 clin stud rep/531 rep biopharm stud/5314 bioanalytanalyt met/report 1/report1.pdf 0000/m5/53 clin stud rep/531 rep biopharm stud/5314 bioanalyt stud/5314 bioanalyt analyt met/report 1/appendix/report appendix.pdf 12

13 PDF Files More details on security settings, and m1.2 now has its own rule to allow for eaf Additional criterion to test for corrupted files PDF versions 1.4, 1.5, 1.6, and 1.7 now all allowed Method of testing PDF version specified Hypertext links only links that work within the software being used to view thedossier aretested Excludes mail links (open e mail client) Excludes web links (open web browser) Bookmark criterion now split bookmarks present, they are visible, no bookmarks, page only 13

14 Hypertext Links New criterion i checks compliance of links as per configuration specified in ISO :2008 Backslashes are not allowed Background Links with backslashes will work on Windows file systems: \\MyDrive\Testing\eCTD\Samples\0000\util\dtd Links with forward slashes will work in all operating environments (eg Smart Phones, Tablets): //MyDrive/Testing/eCTD/Samples/0000/util/dtd 14

15 Y Criteria Text changed: Test marked with Y needs the relevant former sequences for the specific criterion to be present for the result to be fully reliable. If these sequences are not present when testing, any FAIL results for these criteria should be interpreted carefully. When reporting a 'Fail' for these 'Y' criteria, validation tools should also report the specific missing sequences that are related to the 'Fail'. 15

16 Y Criteria Example 11.6 leaf attributes The file referenced by the cross reference (xlink:href) must exist in the same or a previously submitted sequence within the same ectd application P/F Y The link within the XML leaf element is valid, i.e the target exists If a cross reference is not found, the validation report should present this as a Fail, but alsospecify specify which sequence was referred to, and whether or not the sequence was present at the time of doing the test Sequence was present Sequence was not present Reliable FAIL targeted document did not exist Unreliable FAIL targeted document may exist, but this cannot be tested because sequence is missing 16

17 Specific NeeS Criteria Changes 17

18 Table of Contents Module TOCs clarification links must only go to content within that module Original criterion: within the respective mx folder, now Links from a module TOC must not be directed to content outside of that module.. New rule on paths in TOC links The path in hyperlinks and bookmarks from ToC files should never er contain the four digit NeeS folder. 18

19 Hypertext Links Containing the Four Digit NeeS Folder Link../0000/m1/eu/10 cover/be/be cover.pdf cover.pdf resolves OK Once loaded into the agency s system: Link../0000/m1/eu/10 cover/be/be cover.pdf broken, or could point to the wrong letter (in 0000)!...would need to be../0003/m1/eu/10 cover/be/be cover.pdf, but should be m1/eu/10 cover/be/be cover.pdf 19

20 NeeS Acceptable Formats Criterion 2.2 Current criteria refers to ICH ectd Specification Revision PDF only (refers to TIGes Harmonised NeeS Guidance) 20

21 NeeS Folder and File Naming No changes to criteria However, note, specific new folder rules in Files and Folders Q&A sheet, detailed in File Folder Structure & Names sheet are Pass/Fail for NeeS 21

22 Key Points for Vendors of ectd/ NeeS Tools DTD/stylesheet checks all P/F. If you market a tool today that inserts the wrong checksum, or does not use the forward slashes in XML references to DTDs, MOD files etc, all ectds produced in this tool will fail from December 1 st (P/F) Links in NeeS STOCs must not contain the four digit it submission i number (e.g ). If you market a tool today that includes the four digit number in TOC hypertext links, this needs to change, otherwise your tool will be producing invalid NeeS (P/F) If you market software that is supplied with templates for NeeS folder structure, thenewrules onallowed folders will potentially make allnees dossiers made with an existing template fail (P/F) Hypertext links orbookmarks must nothavebackslashes in thepath. If you market a tool today that inserts Windows style links into PDFs for submission in the EU, all links will fail the test (BP). This may be changed to a pass/fail in the future for TOC files and the XML backbone. 22

23 Lastly... The ectd criteria have been updated once more, look out for the most recent proposal p coming soon to the esubmission web site: v4.1 July 2012 Typo corrections on criteria 3.3, and Also, the description of the * ("Y" criteria) is further clarified. 23

24 Questions 24