Regional File Formats Module 1 In addition to the common format PDF, as defined by the , XML will also be accepted whenever a structured exchange standard exists for the content. Currently there are no structured exchange standards for content, however it is expected that these may be introduced in the future for content such as the tracking table, application forms, etc. Note that all PDF included in an eCTD irrespective of the module should be v1.4, v1.5, v1.6 or v1.7 where a specific requirement for a later version is defined (see for further details regarding PDF acceptability). It is preferred that PDFs be generated from an electronic source. Signatures may be embedded as a graphic the PDF text if desired. Modules 2 to 5 No additional file formats are defined for Modules 2 to 5 other than those mentioned in the . Use of Electronic Signatures The use of advanced electronic signatures e.g. digital signatures, will be crucial in achieving pure electronic communication between the pharmaceutical industry and regulatory agencies, particularly for electronic submissions and documents contained therein. Currently the use of digital signatures for submissions is not fully supported within the THAI FDA. Digital signatures can be used but only as an any required written signatures. Scanned signatures would ordinarily be used where the documents make of the checksum of an eCTD submission. Handling of Empty or Missing eCTD Sections For new applications, including generic applications, detailed statements justifying the absence of data or CTD sections should be provided in the relevant Quality Overall Summary and/or Nonclinical/Clinical e.g. Module 2.3, 2.4, or 2.5. Note that placeholder documents highlighting no relevant content should not be in the eCTD structure. Such documents would create a document lifecycle for non-existent documents unnecessary complications and maintenance of the eCTD submissions. For a generic application, there is no need to provide a justification for content that is typically absent. Updating Backbone Attributes/Metadata Updating ICH Attributes Updating XML backbone attributes such as manufacturer during the eCTD lifecycle is possible, however, consideration should be given regarding the impact of changing backbone attributes during the lifecycle as lead to a higher level of complexity in the cumulative view of a submission.
Regional File Formats Module 1 In addition to the common format PDF, as defined by the , XML will also be accepted whenever a structured exchange standard exists for the content. Currently there are no structured exchange standards for content, however it is expected that these may be introduced in the future for content such as the tracking table, application forms, etc. Note that all PDF included in an eCTD irrespective of the module should be v1.4, v1.5, v1.6 or v1.7 where a specific requirement for a later version is defined (see for further details regarding PDF acceptability). It is preferred that PDFs be generated from an electronic source. Signatures may be embedded as a graphic the PDF text if desired. Modules 2 to 5 No additional file formats are defined for Modules 2 to 5 other than those mentioned in the . Use of Electronic Signatures The use of advanced electronic signatures e.g. digital signatures, will be crucial in achieving pure electronic communication between the pharmaceutical industry and regulatory agencies, particularly for electronic submissions and documents contained therein. Currently the use of digital signatures for submissions is not fully supported within the THAI FDA. Digital signatures can be used but only as an any required written signatures. Scanned signatures would ordinarily be used where the documents make of the checksum of an eCTD submission. Handling of Empty or Missing eCTD Sections For new applications, including generic applications, detailed statements justifying the absence of data or CTD sections should be provided in the relevant Quality Overall Summary and/or Nonclinical/Clinical e.g. Module 2.3, 2.4, or 2.5. Note that placeholder documents highlighting no relevant content should not be in the eCTD structure. Such documents would create a document lifecycle for non-existent documents unnecessary complications and maintenance of the eCTD submissions. For a generic application, there is no need to provide a justification for content that is typically absent. Updating Backbone Attributes/Metadata Updating ICH Attributes Updating XML backbone attributes such as manufacturer during the eCTD lifecycle is possible, however, consideration should be given regarding the impact of changing backbone attributes during the lifecycle as lead to a higher level of complexity in the cumulative view of a submission.
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