New FDA M1 Specifications include DDMAC, Bundled Submissions

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The Comprehensive Table of Contents Headings and Hierarchy Version 2.0 and The eCTD Backbone Files Specification for Module 1 Version 2.0 is now available here.

As reported last month, the two significant changes to the specifications are is inclusion of DDMAC submission and bundled submissions.

The largest change to FDA’s regional DTD is now one sequence can be submitted to multiple applications. This is a great feature if you create a single submission and replicate it to send to multiple applications. The only drawback to this plan is once you submit a bundled submission, the lifecycle for the document submitted cannot diverge in any of the applications.

The following is a list of changes from the specification:

  1. The date-of-submission element was removed.
  2. Module 1 heading 1.9.5 “Proposal for written agreement” was removed.
  3. An id element was added under applicant-info to provide the applicant’s or sponsor’s corporate DUNS number issued by Dunn & Bradstreet.
  4. The submission-description element was added and is optional.  The element is limited to 128 characters.  It allows for an additional brief description of the purpose of the submission, but should not contain any reviewable information.
  5. The applicant-contacts element was added to capture contact information. One or more contact names, telephone numbers, and emails may be submitted for each submission, and at least one contact name is required.
  6. The application-set element can contain one or many applications (i.e., bundled submission).  Each application needs to have its own submission information section.  When a bundled submission is submitted, the submission content will reside under a single application, but is referenced by multiple eCTD applications.  The application contains-files element was added to indicate which application contains the files in a bundled submission.  This attribute will be used to identify the root application where the submission files will be stored.
  7. The element cross-reference-application-number was added to provide the ability to list cross-referenced applications.
  8. The sequence number element has been replaced with submission-information element.  The submission-information element contains three elements (submission-id, submission-unit-id, and form).
  9. Certain forms are provided under the submission-information element to allow each application’s form to be displayed within the appropriate application.
  10. Submission type was changed from an element to be an attribute of the submission-id element.  In addition, an attribute of supplement-effective-date-type was added and is also an attribute of the submission-id element.  The supplement-effective-date-type is only applicable if the submission-type is a labeling or CMC supplement.
  11. The submission-unit-id element was added under submission-information element and replaces what was formerly referred to as “sequence number.”
  12. An attribute for submission-sub-type was added to more accurately reflect the nature of a submission unit and its relationship to the associated submission.
  13. Submissions are grouped with their regulatory activity by using the submission-type, submission-id, and submission unit-id.  This functionality replaces the related sequence element from earlier versions of the Module 1 DTD.
  14. Certain admin and module 1 elements (m1-1-forms and the sections and subsections of m1-15-promotional-material) require an attribute.
  15. Additional headings elements were added to 1.15 Promotional Materials to further define the submission of promotional materials.
  16. Additional heading elements were added or revised.  Please refer to the The Comprehensive Table of Contents Headings and Hierarchy for the complete set of changes.
  17. The us-regional.xml refers to, and validates from, supporting and required files (DTD, stylesheet, and value-type lists) located at web site addresses instead of local file paths (previously required files were located in the util folder).  The stylesheet (usregional.xsl) was updated to refer to the new value lists (XML files) and DTD for the purpose of validation and display.
  18. The Heading Table was removed from the Heading Elements for Module 1 section.

Author: Jason Rock

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

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