How the eCTD Works
(Note: This post is part of a multi-part series on the CTD this fall)
The eCTD is, at heart, an electronic structure to organize and present submission for ease of review. The specifications for the eCTD are in the FDA’s Technical Conformance Document and the eCTD Submission standards (find the latest version of these and other eCTD documents at the eCTD program page). The clearest explanation of the eCTD organization is found in chapter F of the current eCTD guidance. The overarching submission structure is provided by a master document or backbone which references the Chapter and subchapter headings from the CTD as XML elements. The document references under each chapter are called eCTD leaf elements. A sponsor need only include the elements and leaf elements that are appropriate for their particular submission type. These elements and leaves link to the files in the eCTD directory and subdirectories, which are organized according to the CTD module structure. The individual files in the submission must comply with the file format and naming conventions defined in the standard in order for the submission to be easily viewed and manipulated by agency reviewers. Most submitters use a purchased eCTD publishing tool to create and package the files for their submission. Once packaged, the submission is transmitted using the FDAs Electronic Submissions Gateway. This seems fairly straightforward, but evidence from the program page and SBIA suggests submissions are rarely error free. My assessment is the program could use an example document showing the structure of the output and a process flow diagram for submission assembly. I have yet to find anything like these on the program pages.
Reach out to me if you want to know more or discuss your medical product development challenges.
https://calendly.com/katrinarogers
Text Copyright © 2019 Katrina Rogers
Follow the links below to read each part of the series.
Electronic Regulatory Submissions Part 1
Electronic Regulatory Submissions Part 2
Electronic Regulatory Submissions Part 3
Electronic Regulatory Submissions Part 4
Electronic Regulatory Submissions Part 5
Electronic Regulatory Submissions Part 6
Electronic Regulatory Submissions Part 7
Electronic Regulatory Submissions Part 8
Electronic Regulatory Submissions Part 9
Electronic Regulatory Submissions Part 10
Electronic Regulatory Submissions Part 11
Electronic Regulatory Submissions Part 12
Electronic Regulatory Submissions Part 14