ࡱ> vxstu` Objbjss 6VG&j $8d|,7,h2" +++++++$<.h0v,", 8,TIII +>I+II(7! @טC8$,H,t1$1h7!17!0"I,,3,777F~$C777~hh 4,   EU Module 1 v1.3 Release Notes May 2008 DOCUMENT CHANGE RECORD VersionDateDescriptionSections0.104/03/2008First versionAll0.212/03/2008Synchronisation with Specification updateAll0.314/03/2008Additional comments2.12, 2.19, 2.20, 2.210.405/05/2008Additional comments2.13, 2.220.507/05/2008Synchronisation with Specifications update2.2, 2.3, 2.4, 2.11, 2.13, 2.14, 2.190.619/05/2008Additional comments2.20, 2.230.722/05/2008Review for publication2.11 Review VersionDatePerson / Group / Company / Agency Distribution VersionDatePerson / Group / Company / Agency Table of contents  TOC \o "1-3" \h \z \u  HYPERLINK \l "_Toc199212611" 1. Introduction  PAGEREF _Toc199212611 \h 4  HYPERLINK \l "_Toc199212612" 2. List of EU Module 1 Changes  PAGEREF _Toc199212612 \h 6  HYPERLINK \l "_Toc199212613" 2.1 Alignment to Updated CTD Module 1  PAGEREF _Toc199212613 \h 6  HYPERLINK \l "_Toc199212614" 2.2 Use of XML Format  PAGEREF _Toc199212614 \h 6  HYPERLINK \l "_Toc199212615" 2.3 Electronic Signature  PAGEREF _Toc199212615 \h 6  HYPERLINK \l "_Toc199212616" 2.4 Guidance on Node Extensions  PAGEREF _Toc199212616 \h 7  HYPERLINK \l "_Toc199212617" 2.5 Use of Applicant Style-Sheets  PAGEREF _Toc199212617 \h 7  HYPERLINK \l "_Toc199212618" 2.6 Operation Attribute for EU Module 1  PAGEREF _Toc199212618 \h 7  HYPERLINK \l "_Toc199212619" 2.7 File Naming Convention  PAGEREF _Toc199212619 \h 7  HYPERLINK \l "_Toc199212620" 2.8 Product Information Filename in Examples  PAGEREF _Toc199212620 \h 8  HYPERLINK \l "_Toc199212621" 2.9 DTD and Style-Sheet Location in Examples  PAGEREF _Toc199212621 \h 8  HYPERLINK \l "_Toc199212622" 2.10 Country Attribute of Envelope  PAGEREF _Toc199212622 \h 8  HYPERLINK \l "_Toc199212623" 2.11 Statement for Absence of Data  PAGEREF _Toc199212623 \h 8  HYPERLINK \l "_Toc199212624" 2.12 Location of Response to Questions  PAGEREF _Toc199212624 \h 8  HYPERLINK \l "_Toc199212625" 2.13 Usage of Related Sequence  PAGEREF _Toc199212625 \h 9  HYPERLINK \l "_Toc199212626" 2.14 List of Agency Names  PAGEREF _Toc199212626 \h 9  HYPERLINK \l "_Toc199212627" 2.15 Display Data in Black  PAGEREF _Toc199212627 \h 9  HYPERLINK \l "_Toc199212628" 2.16 List of Submission Types  PAGEREF _Toc199212628 \h 9  HYPERLINK \l "_Toc199212629" 2.17 References between Module 1 and other Modules  PAGEREF _Toc199212629 \h 9  HYPERLINK \l "_Toc199212630" 2.18 Multiple File References  PAGEREF _Toc199212630 \h 9  HYPERLINK \l "_Toc199212631" 2.19 Additional Data under Centralised Procedure  PAGEREF _Toc199212631 \h 10  HYPERLINK \l "_Toc199212632" 2.20 Location of Supporting Information  PAGEREF _Toc199212632 \h 10  HYPERLINK \l "_Toc199212633" 2.21 Support of PDF Versions  PAGEREF _Toc199212633 \h 10  HYPERLINK \l "_Toc199212634" 2.22 Further Acceptance of XML Format  PAGEREF _Toc199212634 \h 10  HYPERLINK \l "_Toc199212635" 2.23 Additional Guidance on Use of Country and Language Folders  PAGEREF _Toc199212635 \h 10  Introduction This document intends to highlight the differences between the EU Module 1 v1.3 and the EU Module 1 v1.2.1 to assist potential users of the system. The changes within the EU Module 1 v1.3 are summarised here below, sorted per change request (CR), and with indication if Specifications, DTD or Style-sheets have been amended: #ChangeSummarySpecificationsDTD / Style-Sheet AUTONUMLGL \* Arabic \e  HYPERLINK \l "_Alignment_to_Updated_CTD Module 1" Alignment to Updated CTD Module 1 CR: CR-20080303Alignment to the updated CTD Module 1 with addition of section 1.10 for information related to paediatricsRegional Information Appendix 2eu-regional.dtd eu-regional.xsl Examples2HYPERLINK \l "_Use_of_XML_Format_1"Use of XML Format CR: A001European position on the submission of XML instead of PDF / RTF for the content of the dossierRegional File Formats Appendix 2-3 HYPERLINK \l "_Electronic_Signature" Electronic Signature CR: A004European position on the support of electronic signature for e-submissionsUse of Electronic Signature-4 HYPERLINK \l "_Guidance_on_Node_Extensions" Guidance on Node Extensions CR: A010Additional guidance on the usage of node extensions within the EU Module 1Node Extensions-5 HYPERLINK \l "_Use_of_Applicant_Style-Sheets" Use of Applicant Style-Sheets CR: A011Guidance on the usage of applicant style-sheets for the EU Module 1Appendix 2-6 HYPERLINK \l "_Operation_Attribute_for_EU Module 1" Operation Attribute for EU Module 1 CR: 20060524-01The eCTD must always refer the EU Module 1 with the operation attribute set to "new"Appendix 2-7 HYPERLINK \l "_File_Naming_Convention" File Naming Convention CR: CR-20061221-01Further guidance on file naming conventionFile Naming Convention-8 HYPERLINK \l "_Product_Information_Filename_in Exa" Product Information Filename in Examples CR: CR-20070118-01Examples have been corrected regarding the filenames of product information-Examples9 HYPERLINK \l "_DTD_and_Style-Sheet_Location in Exa" DTD and Style-Sheet Location in Examples CR: CR-20070122-01Examples have been corrected regarding the location of DTD and style-sheet-Examples10 HYPERLINK \l "_Country_Attribute_of_Envelope" Country Attribute of Envelope CR: CR-20070309-01Guidance on the usage of the country attribute of the envelopeEnvelope Appendix 4 Appendix 5eu-envelope.mod Examples11 HYPERLINK \l "_Statement_for_Absence_of Data" Statement for Absence of Data CR: QA-20070627-01Further guidance on the provision of statements when no data is providedHandling of Empty or Missing eCTD Sections-12 HYPERLINK \l "_Location_of_Response_to Questions" Location of Response to Questions CR: CR-20070627-01Correction of the Specifications regarding the location of response to questionsAppendix 2-13 HYPERLINK \l "_Usage_of_Related_Sequence" Usage of Related Sequence CR: QA-20070628-01Further guidance on the usage of the related sequence field in the EU Module 1Appendix 1-14 HYPERLINK \l "_List_of_Agency_Names" List of Agency Names CR: QA-20070628-02Provision of the list of agency names to use in the envelope of the EU Module 1Appendix 1 Appendix 2.4 Appendix 5eu-envelope.mod eu-regional.xsl15 HYPERLINK \l "_Display_Text_in_Black" Display Data in Black CR: CR-20070628-01The display of EU Module 1 data is changed from blue to black to avoid confusion between text and hyperlinksAppendix 5eu-regional.xsl16 HYPERLINK \l "_List_of_Application_Types" List of Submission Types CR: QA-20070906-01Provision of the list of submission types to use in the envelope of the EU Module 1Appendix 1 Appendix 5eu-envelope.mod eu-regional.xsl17 HYPERLINK \l "_References_between_Module_1 and oth" References between M1 and other Modules CR: CR-20070906-01Guidance on the possibility to refer files of modules 2-to-5 from the EU Module 1 and vice versaGeneral Architecture of Module 1-18 HYPERLINK \l "_Multiple_File_References" Multiple File References CR: CR-20070927-01Further guidance on the way to refer the same files from multiple locationsGeneral Architecture of Module 1-19 HYPERLINK \l "_Additional_Data_under_Centralised P" Additional Data in CP CR: CR-20071002-01Guidance on the use of "Additional Data" section under Centralised ProcedureAppendix 2-20 HYPERLINK \l "_Location_of_Supporting_Information" Location of Supporting Info CR: CR-20071003-01Further guidance on the provision of supporting information in the same locationAppendix 2-21 HYPERLINK \l "_Support_of_PDF_Versions" Support of PDF Versions CR: CR-20080129-03Further guidance on the PDF versions supported Regional File Formats-22 HYPERLINK \l "_Further_Acceptance_of_XML Format" Further Acceptance of XML Format CR: CR-20080218Guidance on the further acceptance of XML format e.g. for the cover letterRegional File Formats Appendix 2- List of EU Module 1 Changes Alignment to Updated CTD Module 1 Change Request CR-20080303 The Specifications and DTD of the EU Module 1 have been aligned to the updated version of the CTD, to add section 1.10 for the information relating to paediatrics. The style-sheet has been amended accordingly. Use of XML Format Change Request A001 The Specifications provides clarification on the current usage and expected future usage of XML for the content of the dossier. In line with the general principles of the ICH eCTD Specification, it is intended that XML will eventually become the sole submission format for administrative forms and product information documents (as they contain structured data and a long term goal of this development is the normalisation of data in Module 1). As XML documents become available for practical implementation, they will be introduced into Module 1 and the current file formats may ultimately be replaced (after an appropriate transition period). Electronic Signature Change Request A004 The Specifications provides information on the current situation of electronic signature. The use of advanced electronic signatures (digital signatures) will be crucial in achieving pure electronic communication between the pharmaceutical industry and regulatory agencies, particularly for authentication of electronic submissions and documents contained therein. The EU is therefore developing a long-term strategy to implement digital signatures. Currently however, the use of digital signatures for electronic submissions within the EU is not fully supported and digital signatures should therefore not be used. Please refer to individual national guidance for information on the use of electronic signatures. Guidance on Node Extensions Change Request A010 The Specifications provides guidance on the usage of node extensions within the EU Module 1: Node extensions must not be used where ICH specified sub headings already exist (e.g. indication, manufacturer, drug substance, drug product are all ICH specified node extensions). Node extensions must only be used at the lowest level of the eCTD structure (e.g. a node extension can be used at the level 5.3.5.1 but must not be used at the level 5.3). Node extensions are mainly to be used to group together documents made up of multiple leaf elements (e.g. a clinical study made up of separate files for the synopsis, main body and individual appendices could be grouped together under a node extension with the Study Identifier as its Title attribute). Node extensions must be maintained over the entire life of the eCTD lifecycle (e.g. if a node extension is used in Sequence 0000 to group files for a study report in Module 5.3.5.1, then any files submitted in a later sequence must also be placed under a node extension, even if only one file is submitted). Node extensions may be nested as this is allowed by the eCTD DTD. However, as noted in Bullet 2, the first node extension must be at the lowest level in the eCTD structure (e.g. in Module 5.3.7 a node extension may be added to group together files with the Study Identifier as Title attribute). Further node extensions may be added as children of the Study Identifier node, separating CRFs from individual patient listings. Use of Applicant Style-Sheets Change Request A011 The Specifications provides guidance on the usage of applicant style-sheets within the EU Module 1. Little advantage is to be gained by the use of custom stylesheets. The XML instance can only point to one style-sheet and the inclusion of a reference to a style-sheet that is not the regional one would prevent the agency using the official EU style-sheet. It is therefore recommended not to submit customised stylesheets. Operation Attribute for EU Module 1 Change Request 20060524-01 The Specifications provides guidance on the operation attribute to use where referring to the EU Module 1 from the eCTD. The operation attribute should always be set to "new". File Naming Convention Change Request CR-20061221-01 The Specifications provides further guidance on the naming convention to use for files submitted as part of the EU Module 1. The additional information especially covers the position on the usage of hyphens within names, and the way to approach special cases. Product Information Filename in Examples Change Request CR-20070118-01 The Examples have been corrected regarding the filenames of product information. The prefix of those filenames needs to be set to the country instead of the language. DTD and Style-Sheet Location in Examples Change Request CR-20070122-01 The Examples have been corrected to locate the DTD and style-sheet within the "util" folder of eCTD, instead of the "util" folder of the EU Module 1. Country Attribute of Envelope Change Request CR-20070309-01 The Examples have been corrected regarding the possible values for the country attribute of the envelope. The envelope should be repeated for each Member State and the value "common" should not be used. Statement for Absence of Data Change Request QA-20070627-01 For new applications (including generic applications), detailed statements justifying the absence of data or specific CTD sections should be provided in the relevant Quality Overall Summary and/or Non Clinical/Clinical Overviews (Module 2.3, 2.4, 2.5). Note that placeholder documents highlighting 'no relevant content' should not be placed in the eCTD structure, as these would create a document lifecycle for non-existent documents, and unnecessary complication and maintenance of the eCTD. For a generic application, note that there is no need to provide a justification for content that is typically absent. Location of Response to Questions Change Request CR-20070627-01 The Specifications have been corrected to locate the response to questions as part of section "Responses to Questions", and not as an annex to the cover letter. Usage of Related Sequence Change Request QA-20070628-01 The Specifications provides additional guidance on the usage of the related sequence. The related sequence attribute should always be left blank for new applications or new regulatory activities (e.g. variations, PSURs). When submitting lifecycle sequences within an existing activity, the related sequence attribute should be populated with the sequence number of the first sequence in the activity, regardless of how many sequences make up the activity. The related sequence attribute should be considered independent of any modified file attributes in a submission. The EU Module 1 Specifications also provide an example on how to use the related sequence. The Related Sequence field has been amended in the EU Module 1 envelope, so as to remove the country attribute. List of Agency Names Change Request QA-20070628-02 The Specifications and the DTD provide the list of agency codes to be used in the envelope of the EU Module 1, as well as the agency name related to each code. Display Data in Black Change Request CR-20070628-01 Data of the EU Module 1 display now in black colour so as to avoid confusion with hyperlinks. List of Submission Types Change Request QA-20070906-01 The Specifications and the DTD provide the list of submission types to be used in the envelope of the EU Module 1. References between Module 1 and other Modules Change Request CR-20070906-01 The Specifications provide guidance on the possibility to refer files across different modules of the eCTD. Files of the module 2-to-5 can be referred from the EU Module 1 and vice versa. Multiple File References Change Request CR-20070927-01 The Specifications provide additional guidance on the way to refer the same files from more than one leaf location. Additional Data under Centralised Procedure Change Request CR-20071002-01 The 'Additional Data section should only be used for information required for National, MR and Decentralised Procedures; it is therefore not applicable for the Centralised Procedure. The only occasion where this section should be used for all procedures is when an old version of a DTD is being used, during an agreed transition period, to support inclusion of a newly defined section of Notice to Applicants (refer to guidance issued with specification). Location of Supporting Information Change Request CR-20071003-01 The Specifications provide additional guidance on location where to store additional data like supporting information for variations. Supporting data for variations should be not be placed in "Additional Data" section; wherever possible they should be placed in the relevant CTD section, primarily within Module 3 Quality and Module 1 (1.3.1) Summary of Product Characteristics, Labelling and Package Leaflet. Where documents cannot be assigned to specific CTD-defined locations, then they should be attached to the 1.2 Application Form. The 'Additional Data section should only be used for information required for National, MR and Decentralised Procedures; it is therefore not applicable for the Centralised Procedure. Support of PDF Versions Change Request CR-20080129-03 The Specifications provide additional guidance on the PDF version to use within the EU Module1. Further Acceptance of XML Format Change Request CR-20080218 The Specifications provide guidance on the further acceptance of XML format, especially for the Tracking Table to provide along the Cover Letter to identify all the sequences that have been submitted to the agency. Additional Guidance on Use of Country and Language Folders Change Request - The Specifications provide additional guidance on the use of the country and language folders for the Centralised Procedure (folder "emea" and language subdirectories for Module 1.3.1) and for the other procedures (use of country folder, with possibility to use the "common" folder; use of language subdirectories for Module 1.3.1, with possibility to use the "VAR" part of the filename if there is one language for the country).     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