US FDA Updated eCTD Technical Conformance Guide (v1.3)

FDA has updated the guideline for eCTD Technical Conformance Guide (v1.3). In this version FDA;

  • Updated/Clarified following sections;
Section Number Updation and Clarification
Section 2.5
(eCTD Submission Tracking and Life Cycle)
  • Heading name updated from eCTD Life Cycle to eCTD Submission Tracking and Life Cycle
  • Added New Paragraph i.e. The rules for submission tracking information (i.e., the allowable submission types for the application) can be found in the Module 1 specification
  • Section 2.8
    (Study Tagging Files)
  • Clarified statement that STFs is not required for Module 4.3 Literature references also.
  • In previous version, this statement was specified only for Module 5.2 Tabular listings, 5.3.6 Postmarketing reports and, 5.4 Literature references only
  • Section 3.1.10
  • Updated third paragraph of Section 3.1.10 – If new proposed REMS or modifications to an approved REMS is submitted as part of an efficacy, CMC, or labeling supplement, the submission type should be coded with the appropriate supplement type (e.g., either efficacy, CMC, or labeling). On the 356h form, you should select both supplements for the submission type.

    • Added section;
    Section Number Added New Section Description
    (Regenerative Medicine Advanced Therapy Designation)
  • Currently there is no Module 1 section for RMAT designation requests. Therefore, please place the RMAT designation request in section 1.12.4 and provide a hyperlink in the cover letter to the request.
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