The Move to eCTD v4
(Note: This post is part of a multi-part series on the CTD this fall)
The eCTD version current at the time of the post is v.3.2.2, with the complete specification contained in this 2008 document. This document has the clearest explanation I’ve found of the rationale for the system ‘s design and structure in Appendix 1. The eCTD Implementation Working Group maintains the current version and any changes under a change control process. Change requests may be submitted at any time and some will be implemented in minor releases without changing the version. As with any software in use, it’s not long before user feedback and regulatory experience points to changes with a scope too broad or complex to avoid a new version. The M8 Expert Working Group (M8 is the designation for the eCTD guidance) was started work on version 4 in 2010. The implementation package has been prepared and endorsed by the ICH Assembly in June 2018, and implementation has begun in the EU, US, and Japan. A nice overview of the changes is available in this ICH slide deck. Keep in mind the eCTD is an XML organization structure meant to keep the metadata of the application (the relationships between the different parts of the application) clear to submitters and reviewers. The changes in this revision appear to enhance the clarity of the application through additional keywords, defined word lists (called controlled vocabularies), and additional ways to order and group content. More information about version 4 may be found at the Step 4 (implementation) page. One important point from the slide deck is the Implementation Working Group feels version 4 will be too complex to create submissions manually, and an eCTD tool will be required to build and maintain an application through its life cycle. Vendors in the regions where implementation has begun are being asked to take a vendor readiness survey as the version cannot be implemented without tools.
If you’ve had enough of eCTD, so have I (for now).
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 13