TW Validation 2.1 (Full) TW 2.1 en Full TW Validation Criteria v2.1 with additional recommended criteria. The specified filename is used 6.17.57 The file is placed in the correct folder. 6.17.57 A currently acceptable version of the DTD is used (checksum matches the published value). 6.17.46 The specified filename is used. 6.17.58 The file is placed in the correct folder 6.17.58 The checksum for the stylesheet used must match the published checksum for the stylesheet associated with the DTD used for the sequence. 6.17.55 The specified filename is used 6.17.57 The file is placed in the correct folder. 6.17.57 A currently acceptable version of the DTD is used (checksum matches the published value). 6.17.47 The specified filename is used 6.17.57 The file is placed in the correct folder. 6.17.57 The checksum for the tw-leaf.mod file used must match the published checksum for the tw-leaf.mod file associated with the DTD used for the sequence. 6.17.47 The specified filename is used. 6.17.57 The file is placed in the correct folder. 6.17.57 The checksum for the tw-envelope.mod file used must match the published checksum for the tw-envelope.mod file associated with the DTD used for the sequence. 6.17.47 The specified filename is used. 6.17.58 The file is placed in the correct folder. 6.17.58 The checksum for the stylesheet used must match the published checksum for the stylesheet associated with the DTD used for the sequence. 6.17.55 The file is placed in the correct folder. 6.17.39 The file is named correctly. 6.17.56 The file is well formed. 6.17.48 The file is valid. 6.17.48 The reference to the DTD in index.xml is directed to the DTD provided in the util folder. 6.17.52 The reference to the stylesheet in index.xml is directed to the stylesheet provided in the util folder. 6.17.51 The file is placed in the correct folder 6.17.53 The file is named correctly 6.17.54 The regenerated checksum for the index.xml matches the value in the file index-md5.txt. 6.17.5 The file is placed in the correct folder. 6.17.39 The file is named correctly. 6.17.56 The file is well formed. 6.17.48 The file is valid. 6.17.48 The reference to the DTD in tw-regional.xml is directed to the DTD provided in the util folder. 6.17.52 The reference to the stylesheet in tw-regional.xml is directed to the stylesheet provided in the util folder. 6.17.51 The UUID is well formed according to ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005 6.17.239 The UUID in this incoming sequence must be identical to the one in the previous sequence. Lifecycle needed. 6.17.240 All the lowest level heading elements in the XML (including node-extensions) included in the submission contain at least one leaf. 6.17.19 The leaf attribute ‘checksum-type’ has a value of md5 or MD5 6.17.2 The regenerated checksum for each file matches the value in the leaf attribute ‘checksum’. Lifecycle needed. 6.17.7 For every leaf the ‘title’ attribute is not empty 6.17.25 All leaves with an operation attribute value of new, replace or append must have a value for the cross reference (xlink:href) 6.17.27 All leaves with an operation attribute value of delete must have no value for the cross reference (xlink:href) 6.17.26 The file referenced by the cross reference (xlink:href) must exist in the same or a previously submitted sequence within the same eCTD application. Lifecycle needed. 6.17.28 All leaves with an operation attribute value of replace, delete or append must have a value for modified-file. 6.17.13 All leaves with an operation attribute value of new must have no value for modified-file. 6.17.42 The leaf referenced by the modified file must exist in a previously submitted sequence within the same eCTD application. Lifecycle needed. 6.17.14 For all leaves (except leaves within node extensions and leaves in module 3.2.A) with an operation attribute value of replace, delete or append, the modified file must be present in the same CTD section of the dossier. Lifecycle needed. 6.17.82 Two leaf elements should not have the same leaf ID. 6.17.298 For all leaves with an operation attribute value of replace, delete or append the modified file must not have been replaced or deleted by any other leaf element in any sequence including the current one. Lifecycle needed. 6.17.299 For all leaves within node extensions or module 3.2.A with an operation attribute value of replace, delete or append, the modified file should be present in the same node extension or attribute-defined section. Lifecycle needed. 6.17.265 ICH attributes must not contain leading or trailing spaces, nor start or end with hyphens. Lifecycle needed. 6.17.297 For every node-extension the ‘title’ attribute is not empty. 6.17.25 The sequence folder name is a 4 digit number 6.17.30 The sequence number (folder name) has not already been used. Lifecycle needed. 6.17.32 The sequence folder name matches the sequence number in each envelope in tw-regional.xml 6.17.31 Sequence number follows correct order. Lifecycle needed. 6.17.238 If the submission unit type is ‘initial’ or ‘reformat’ then the related-sequence attribute must have a value equal to the current sequence. 6.17.247 If the submission unit type is not equal to ‘initial’ or ‘reformat’ then the entry for related sequence must not be equal to the value for the current sequence. 6.17.74 The INN attribute is given if submission unit is ‘initial’ 6.17.300 Drug permit license need to be provided by applicants only when submission objective is ‘change’ or ‘extension’ or ‘expiration’. 6.17.357 The invented name code of the envelope should be filled in for the regulatory activity. 6.17.358 The files provided in the folders for Module 1 are in acceptable formats 6.17.44 The files provided in the folders for Module 2-5 are in acceptable formats 6.17.44 Total file folder path length must not exceed 180 characters. 6.17.35 File names, including the extension, must not exceed 64 characters. 6.17.33 Folder names must not exceed 64 characters 6.17.33 Only valid characters are used in file names 6.17.34 Only valid characters are used in folder names. 6.17.34 There are no unreferenced files in M1, M2, M3, M4 and M5 folders. 6.17.37 The only files in the sequence folder (/XXXX/…) are the index.xml and index-md5.txt 6.17.37 There are no empty folders 6.17.62 The sections m1.1.1 contain valid documents 6.17.359 The folder name of the topest folder should be the same as pre-assigned application number. 6.17.163 Individual files do not exceed 500 MB in size 6.17.21 The recommended folder structure and folder names in the ICH and TW specifications are used. 6.17.49 The recommended file names from the ICH and TW specifications are used for all files. 6.17.49 No PDF has been created and saved as version 1.3 or earlier 6.17.18 The submission does not contain corrupted files 6.17.43 Files have been created and saved as PDF 1.4, 1.5, 1.6 or PDF 1.7. 6.17.18 Hyperlinks and bookmarks within documents, or between documents within the same sequence, have a valid target. 6.17.17 All hyperlinks and bookmarks are set to ‘inherit zoom’. 6.17.63 PDFs must have ‘Fast Web View’ active 6.17.16 PDF Document Properties for the Initial View are set for ‘Page Layout = Default’ and ‘Magnification = Default’. 6.17.12 All PDF hyperlinks and bookmarks are relative. 6.17.15 The bookmarks pane should be visible if bookmarks are included within a PDF document. 6.17.10 The bookmarks pane should not be visible if there are no bookmarks included within a PDF document 6.17.11 All hyperlinks and bookmarks between two PDFs must be configured as specified in ISO 32000-1:2008 6.17.67 All non standard fonts are embedded 6.17.102 There are no further security settings to open any individual file. 6.17.40 There are no further security settings applied to any individual file. 6.17.40 Ensure that 'checksum' attribute is present and value for the attribute is provided (i.e. not empty string) when 'operation' attribute for the leaf(s) is 'new', 'append' or 'replace' 6.17.3 Ensure that 'checksum' attribute value is not provided when 'operation' attribute for the leaf(s) is 'delete' 6.17.4 Ensure that invalid formatting is not provided for 'checksum' in index-md5.txt (32 characters are not specified for the MD5 checksum, or included trailing spaces or carriage returns) 6.17.6 Ensure that all files must have one and only one file extension 6.17.9 Ensure that value for ID attribute must start with a letter or underscore character 6.17.20 Allow users to configure file size limit for special file types (i.e. xpt). For all other file types (where configuration is not specified), default max file size value in the 'Check for File Size' field shall be used for validation 6.17.23 Ensure there is no reference leaf(s) point to a file (outside of the eCTD lifecycle) across application (xlink:href points to a different application) 6.17.24 Ensure that the xlink:href and/or modified-file attribute conforms to the eCTD standard (valid characters - no backslash '\', colon':', asterisk'*', question mark'?', less than'<', greater than'>', pipe'|', or space ' ', file path relative to the backbone xml files and includes file name in the path) 6.17.29 Ensure that 'util' folder exists and is in the correct location (<sequence number>/util) 6.17.38 Ensure that the syntax of the modified-file attribute is in accordance with the ICH 3.2 DTD version 6.17.41 Ensure that all files and folders in the submission are accessible to the user 6.17.64 Ensure that the ICH DTD versions used in the current sequence (sequence being tested) is equal to or higher than the DTD version used in the numerically preceding sequence of the application 6.17.65 Ensure that the regional DTD versions used in the current sequence (sequence being tested) is equal to or higher than the DTD version used in the numerically preceding sequence of the application 6.17.66 Ensure that the hyperlinks and/or bookmarks in the submission documents does not target document outside current eCTD application 6.17.69 Ensure that the ICH DTD version used in the current sequence (sequence being tested) is equal to or lower than the DTD version used in the numerically succeeding sequence of the application 6.17.80 Ensure that the regional DTD version used in the current sequence (sequence being tested) is equal to or lower than the DTD version used in the numerically succeeding sequence of the application 6.17.81 Provide list of all documents in the submission containing annotation (other than links and bookmarks) 6.17.83 Ensure that all pdf documents in the submission must not have any attachments 6.17.84 Ensure that all hyperlinks and bookmarks in the submission documents must not have multiple actions (e.g. opening two different pages) 6.17.85 Ensure that all hyperlinks and bookmarks (internal, external, same sequence, across sequences and across applications) in the submission documents are not inactive (without any action) 6.17.86 Ensure that all hyperlinks and bookmarks in the submission documents must not have unknown action (links that could not be identified or contain JavaScript code) and print total count 6.17.87 Ensure that all hyperlinks and bookmarks in the submission documents must not point to external destinations (other than web or email) 6.17.88 Ensure that all hyperlinks and bookmarks in the submission documents must not point to web address or email 6.17.89 Print the count of all of the hyperlinks and the bookmarks with following criteria: - Non-Relative Hyperlinks - Non-Relative Bookmarks - Web link and email hyperlinks - Web links and email bookmarks - External Hyperlinks (excluding web links and emails) - External Bookmarks (excluding web links and emails) - Unknown Action Hyperlinks - Unknown Action Bookmarks - Inactive Hyperlinks - Inactive Bookmarks - Broken Hyperlinks (separate count for inter-application, intra-application and intra-sequence) - Broken Bookmarks (separate count for inter-application, intra-application and intra-sequence) - Number of bookmarks per document - Total number of bookmarks in the submission - Number of hyperlinks per document - Total number of hyperlinks in the submission 6.17.90 Ensure that the link and/or bookmark destination does not point to a corrupt document 6.17.91 Ensure that the links and/or bookmark in the submission documents point to an existing page and/or named destinations. 6.17.92 Ensure that all documents in the submission are text searchable 6.17.93 Ensure that 'title' element of the 'leaf' and/or 'node-extension' does not begins or ends with a space 6.17.167 Ensure that valid/supported 'dtd-version' is referenced in the ICH and regional backbone xml files 6.17.170 Ensure that 'dtd-version' is referenced in the ICH and regional backbone xml files 6.17.173 Ensure that required attributes (e.g. 'indication' in the section 5.3.5 element or 'type of control' in the STF XML file for a study in section 5.3.5.1) are present in the back bone xmls (index and regional) and in the heading element of STF XML file(s) 6.17.176 Ensure that attribute (i.e. substance, company-name, species) values in ICH, regional and/or STF backbone files does not begins or ends with a space 6.17.177 Ensure that non-required files are not present in the util folder (i.e. submission does not have an stf or leaf but the stylesheet and dtd files are present in the util folder) 6.17.178 Ensure that operation attribute is present and valid value ('new', 'append', 'replace' or 'delete') for the attribute is provided 6.17.180 Ensure that 'append' operation is not applied on an existing lifecycle 'append' leaf (E.g. Detect invalid life cycle pattern: sequence 0001 appends a document in sequence 0000, sequence 0002 append operation leads to the append in 0001.) 6.17.199 Ensure that leaf lifecycle operation ('append', 'replace' or 'delete') is not applied to a lifecycle 'delete' leaf (E.g. sequence 0001 deletes a document in sequence 0000, sequence 0002 any life cycle operation leads to the already deleted leaf in 0001.) 6.17.200 Ensure that a leaf is not lifecycled ('append', 'replace' or 'delete') by more than one leaf to cause branching (i.e. scenario where a append/replace/delete operation is being applied on a leaf, which has already been replaced by another leaf. E.g. sequence 0001 replaces a document in sequence 0000, sequence 0002 append operation leads to the already replaced leaf in 0000.) 6.17.201 Ensure same xlink:href is not referenced more than once in the backbone xml files 6.17.202 Ensure that all element in the submission backbone xml files must have leaf child nodes 6.17.204 Ensure that xlink:href attribute in backbone xml files does not point to leaf outside current sequence 6.17.205 Ensure that 'xlink:href' attribute in backbone xml files does not point to leaf outside application 6.17.206 Ensure that only operation 'new' is used for all leafs in the initial sequence of the application 6.17.207 Ensure multiple lifecycle operations on same document in same sequence are not allowed (E.g. sequence 0001 includes two lifecylce operations referencing the same leaf in sequence 0000.) 6.17.209 Ensure attribute (if present i.e. indication, excipient, dosage-form, manufacturer, product-name, substance etc.) value must not be empty string 6.17.212 Ensure that the initial sequence of the application must be '0000' 6.17.213 Ensure that the sequence being validated is the highest sequence in the application 6.17.217 Ensure that the reference for the regional xml backbone file in index.xml must have operation attribute value 'new' 6.17.218 Ensure that the reference for the regional xml backbone file in index.xml must have operation attribute value 'new' 6.17.219 Ensure that 'm1' folder must exist in the submission 6.17.220 Ensure that there is a stylesheet declaration in backbone xml files (index, regional and STF) 6.17.229 Ensure PDF documents with more than 10 pages must have bookmarks 6.17.281