ZA Validation 3.0 (Full) ZA 3.0 en Full ZA Validation Criteria v3.0 with additional recommended criteria. Expected documents and documents that should not be provided 6.17.39 6.17.56 6.17.65 6.17.66 6.17.80 6.17.81 STF Identification 6.17.214 Folder name syntax must be correct 6.17.33 6.17.34 Folders must not be empty 6.17.62 Sequence Root folder does not contain unspecified files 6.17.37 Folder m1 exists and no files are placed there. 6.17.37 Only folders m2, m3, m4, m5 and util exist 6.17.37 6.17.62 Folder util exists and contained files are correct 6.17.8 6.17.38 6.17.46 6.17.47 6.17.57 6.17.178 6.17.402 6.17.55 6.17.58 Sequence folder should be four digits 6.17.30 Applications should start with sequence folder 0001 6.17.213 6.17.366 File name syntax must be correct 6.17.35 6.17.36 6.17.33 6.17.34 Unreferenced files are not allowed 6.17.37 File size limits should not be exceeded 6.17.21 6.17.22 File types (file extensions) check 6.17.9 6.17.44 6.17.45 File index.xml must exist 6.17.39 The index.xml file must be valid 6.17.48 6.17.20 6.17.41 Attribute checksum-type 6.17.2 MD5 Checksum 6.17.7 MD5 for Index file 6.17.5 6.17.53 6.17.54 The reference to the DTD in index.xml is directed to the DTD provided in the util folder. 6.17.52 The files referenced by the cross reference (xlink:href) must exist 6.17.28 Only relative references are being used 6.17.29 References to targets outside Application 6.17.206 References to targets outside Sequence 6.17.205 m1-administrative element must exist 6.17.211 Element must have leaf 6.17.19 Required Attribute value checks 6.17.212 Optional Attribute value checks 6.17.212 Leaf title must not be empty 6.17.25 Node Extensions are appropriately placed 6.17.367 Node Extension title must not be empty 6.17.25 Node Extension exists for all Clinical Studies 6.17.368 Node Extension naming convention for content provided in 5.3.6 6.17.370 Node Extension elements in 3.2.R 6.17.347 Node Extension naming convention for content provided in 3.2.R 6.17.347 CEP/CPQ Naming Convention 6.17.450 Multiple operations on the same document in the same Sequence are not allowed 6.17.209 Leaf operation attribute 6.17.13 6.17.26 6.17.27 6.17.207 6.17.42 Modified file existence 6.17.14 Do not relocate Content 6.17.82 6.17.265 Use of Append 6.17.230 Detect invalid lifecycle pattern: Append operations causing branches 6.17.201 Detect invalid lifecycle pattern: Delete operations causing branches 6.17.201 Detect invalid lifecycle pattern: Replace operations causing branches 6.17.201 Detect invalid lifecycle pattern: Operation on deleted leaf content 6.17.200 Detect invalid lifecycle pattern: Append operations not appending to most recent STF leaf 6.17.210 Replace should not provide content identical to the previous file 6.17.208 ICH File reuse 6.17.202 Missing Content in section 3.2.S 6.17.371 Missing Content in section 3.2.P 6.17.371 Module 1 (regional xml file) exists 6.17.39 The regional backbone file must be valid. 6.17.48 6.17.20 MD5 Checksum 6.17.7 6.17.54 Attribute checksum-type 6.17.2 HTML Rendition of Regional Backbone 6.17.451 The reference to the Schema in za-regional.xml is directed to the Schema provided in the util folder. 6.17.52 The files referenced by the cross reference must exist 6.17.28 Only relative references are being used 6.17.29 References to targets outside Application 6.17.206 References to targets outside Sequence 6.17.205 Element must have leaf 6.17.19 Leaf title must not be empty 6.17.25 Node Extensions are appropriately placed 6.17.333 Node Extension title must not be empty 6.17.25 Multiple operations on same document in same Sequence are not allowed 6.17.209 Leaf operations 6.17.13 6.17.26 6.17.27 6.17.207 6.17.42 Modified file existence 6.17.14 Do not relocate Content 6.17.82 6.17.265 Use of Append 6.17.230 Detect invalid lifecycle pattern: Append operations causing branches 6.17.201 Detect invalid lifecycle pattern: Delete operations causing branches 6.17.201 Detect invalid lifecycle pattern: Replace operations causing branches 6.17.201 Detect invalid lifecycle pattern: Operation on deleted leaf content 6.17.200 Replace should not provide content identical to the previous file 6.17.208 Regional File Reuse 6.17.202 Letter of Application operation attribute 6.17.181 Note to Evaluator operation attribute 6.17.373 Correspondence from SAHPRA operation Attribute 6.17.373 Response to SAHPRA Request operation Attribute 6.17.373 Application Form operation attribute 6.17.181 Proof of Payment operation attribute 6.17.280 Electronic Copy Declaration operation attribute 6.17.280 Validation Templates (Checklists) operation attribute 6.17.445 Tabular Schedule of Amendments operation attribute 6.17.280 Professional Information (PI) operation attribute (including all subnodes) 6.17.232 Reference Product - Local operation attribute (including all subnodes) 6.17.232 Patient Information Leaflet operation attribute (including all subnodes) 6.17.232 Labels operation attribute (including all subnodes) 6.17.232 Foreign Prescribing and Patient Information operation attribute 6.17.232 Artwork and Pictures of Samples operation attribute 6.17.232 Batch Manufacturing Record of the Sample operation attribute 6.17.232 CoA of the Sample operation attribute 6.17.232 Date of Last Inspection of each Site operation attribute 6.17.232 Latest GMP Certificate or a Copy of the Appropriate Licence operation attribute 6.17.232 Confirmation of Contract operation attribute 6.17.232 SAPC Registration operation attribute 6.17.232 Inspection Flow Diagram operation attribute 6.17.232 Organogram operation attribute 6.17.232 Risk Management Plan operation attribute 6.17.232 Tabulated List of Foreign Regulatory Status operation attribute 6.17.232 1.0.1 Letter of Application must exist 6.17.267 1.0.4 Response to Input Request must exist if the Sequence Type is 'Response' 6.17.400 1.2.1 Application Form must exist 6.17.268 1.2.2.4 Electronic Copy Declaration must exist 6.17.269 1.2.5 Validation Template must exist 6.17.270 1.5.2.1 Tabulated Schedule of Amendments must exist 6.17.275 Provide New Source Files 6.17.401 Provide Replaced Source Files 6.17.401 Delete File where Source Files are required 6.17.401 Provide at most ONE document per sequence per the SAHPRA M1 Granularity Annex 6.17.408 Envelope: application 6.17.375 Envelope: application (Attribute Code Validity) 6.17.376 Envelope: application-id 6.17.446 Envelope: application-id is the same as the Application folder 6.17.447 Envelope: application-number 6.17.415 Envelope: proprietary-name 6.17.387 Envelope: dosage-form 6.17.448 Envelope: inn 6.17.379 Envelope: apimf-number 6.17.449 Envelope: pmf-number 6.17.385 Envelope: pmf-number provided when PMF content included 6.17.386 Envelope: vamf-number 6.17.452 Envelope: vamf-number provided when VAMF content included 6.17.452 Envelope: smf-number 6.17.453 Envelope: submission 6.17.389 Envelope: submission (Attribute Code Validity) 6.17.390 Envelope: submission (Multiple Submissions in eCTD) 6.17.412 Envelope: submission (Submission Combination Validity) 6.17.391 Envelope: submission (Application Withdrawal not allowed as only sequence of an Application) 6.17.392 Envelope: evaluation-path 6.17.454 Envelope: evaluation-path (Attribute Code Validity) 6.17.455 Envelope: evaluation-pathway (Multiple Submissions) 6.17.456 Envelope: submission-lead 6.17.442 Envelope: submission-lead (Attribute Code Validity) 6.17.443 Envelope: submission-number 6.17.394 Envelope: sequence 6.17.395 Envelope: sequence (Attribute Code Validity) 6.17.396 Envelope: sequence-description 6.17.397 Envelope: sequence-date 6.17.398 Envelope: sequence-date (Not outdated) 6.17.369 Envelope: sequence-number 6.17.409 6.17.32 Envelope: sequence-number (Must match Sequence Folder name) 6.17.31 Envelope: related-sequence-number 6.17.372 Envelope: related-sequence-number (Number value) 6.17.203 Envelope: related-sequence-number (Sequence Type 'Initial' references itself) 6.17.403 Envelope: multiple-applications 6.17.457 Envelope: multiple-applications (Attribute Values) 6.17.457 Envelope: contact 6.17.410 Envelope: contact (Attribute Code Validity) 6.17.411 Envelope: contact-name 6.17.414 Envelope: contact-email 6.17.374 Required documents and prohibited documents 6.17.407 Expected documents and documents that should not be provided 6.17.407 Possible Documents 6.17.407 Content Checklist 6.17.458 Check index reference 6.17.139 Check index reference (title match) 6.17.187 No backslash in xlink:href reference 6.17.186 STF leaf elements must reference other STF leaf upon append 6.17.183 STF cannot reference another STF 6.17.141 STF files must reference at least one leaf 6.17.140 Cumulative STF files are not allowed 6.17.459 Content Blocks are not accepted 6.17.106 Study Identifier category must not be empty 6.17.185 Study Identifier study-id must not be empty 6.17.132 Study Identifier title must not be empty 6.17.130 Categories and file tags 6.17.184 Category information must be provided for certain STFs 6.17.182 Invalid STF TOC location 6.17.135 STF doc-content file tag count 6.17.134 Study ID for STF must remain constant 6.17.138 Informational output about the number and total size of non E3 documents. 6.17.216 PDF documents must be readable 6.17.43 Bookmarks must be relative 6.17.15 Bookmarks with web or email destinations 6.17.89 Bookmarks with destinations outside repository root folder are not allowed 6.17.88 Bookmarks must not have multiple actions 6.17.85 Bookmarks must not be inactive 6.17.86 Bookmarks must not be broken 6.17.17 Bookmarks must be 'Inherit Zoom' 6.17.63 Bookmarks should exist in all larger documents 6.17.281 Bookmarks meet ISO 32000-1:2008 requirements 6.17.67 Hyperlinks must be relative 6.17.15 Hyperlinks with destinations outside repository root folder are not allowed 6.17.88 Hyperlinks must not have multiple actions 6.17.85 Hyperlinks must not be inactive 6.17.86 Hyperlinks must not be broken 6.17.17 Hyperlinks must 'Inherit Zoom' 6.17.63 Hyperlinks must exist in the Validation Templates 6.17.273 Hyperlinks must exist in Patient Information Leaflet to the Professional Information 6.17.271 Hyperlinks must exist in the Professional Information 6.17.272 Hyperlinks must exist in the Tabulated Schedule of Amendments 6.17.274 Hyperlinks meet ISO 32000-1:2008 requirements 6.17.67 Hyperlinks with web or email destinations 6.17.89 PDF documents should not have any security settings 6.17.40 PDF documents must not be password protected 6.17.40 PDF version must be correct 6.17.18 PDF documents with attachments are not allowed 6.17.84 PDF initial view must be correct 6.17.10 6.17.11 6.17.12 PDF should have 'Fast Web Access' active 6.17.16 PDF documents with annotations 6.17.83 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 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 that all files and folders in the submission are accessible to the user 6.17.64 Ensure that the hyperlinks and/or bookmarks in the submission documents does not target document outside current eCTD application 6.17.69 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 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 'property' element (if present) is listed before its sibling 'file-tag' element in all of the stf files of the submission 6.17.107 Ensure that child element 'title' is not provided in the doc-content of the STF files in the submission. 6.17.109 Ensure that an STF xml file is referenced in a submission only once 6.17.129 Ensure that STF files are not missing in the submission (i.e. xlink:href contains ‘stf-xxxxxxxx.xml’ but system is not able to locate the file) 6.17.131 Ensure that STF title (within study-identifier element) in the stf xml file matches with the leaf title for the stf in the index.xml file. 6.17.133 Ensure that STF’s in the submission are named correctly based on the naming convention i.e. ‘STF-<study-id>.xml’ 6.17.136 Ensure that STFs in the submission have valid file extension (file extension is not missing and it is .xml). 6.17.137 Ensure that files in study sections are referenced by an STF 6.17.142 Ensure that valid STF DTD version (e.g. dtd-version = "2.2") is referenced in the STF XML file 6.17.143 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 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 all element in the submission backbone xml files must have leaf child nodes 6.17.204 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' 6.17.219 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 that the sequence numbers in an application are increased incrementally (The sequence number related to the life cycle should increase incrementally with each subsequent submission, for example 0000, 0001, 0002 etc. (the increase should occur in chronological order) 6.17.238 Ensure that only one dataset of each type (filename configured) referenced in an STF is marked as 'new' operation. This is applicable for Module 4 and Module 5. 6.17.259