Module 1 and Regional Information Version 1.0 Version History Version Description of change Effective date V0.90 Original draft publication for pilot implementation and industry review 01/07/2014 V0.91 Inconsistencies with Schema updated. Updated Heading 1.3.1.3.3.1 07/08/2014 V0.92 Update format of eSubmission Identifier Require document in Business Protocol 07/10/2014
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.
Sequence Number Four digit sequence number matching the sequence folder being submitted. Example: 0000 Related Sequence Number The related sequence number is used to group sequences within an eSubmission. This will allow easy sequences associated with a particular regulatory activity among the multiple activities submitted during the lifecycle of the eSubmission. The four (4)-digit related sequence no. for each regulatory activity is the of the initial sequence of that regulatory activity. Therefore, all sequences that belong to a specific regulatory activity should contain the same four (4)-digit number in the related sequence no field. Sequence Related Sequence Sequence Type Sequence Description 0000 0000 A: Pharmaceutics - New Chemical Entity Initial Application 0001 0000 J: Supplementary Information Response to Request for Information Date: 0002 0000 J: Supplementary Information Response to Request for Information Date: 0003 0000 J: Supplementary Information Response to Request for Information Date: 0004 0004 F: Variation - Major Variation (MaV) Initial Variation 0005 0005 H: Periodic Safety Update Report Initial Report 0006 0006 F: Variation - Minor Variation (MiV-PA) Initial Variation