What’s the Current eCTD Guidance?
(Note: This post is part of a multi-part series on the CTD this fall)
In my previous post, we reviewed the types of submissions for which the FDA requires eCTD format. One of the earliest guidance for eCTD still available was issued in January of 1999, and it starts with a background section with a list of FDA actions related to electronic submissions. This document goes on to discuss technical aspects of such submissions including acceptable file formats and media types (when was the last time you used a 3.5 floppy disk?). It’s not clear when the first version of the guidance “Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product and Related Submissions Using the eCTD Specifications” was issued, as earlier versions can’t be found on the current guidance search page or on the regulations.gov page. It’s updated fairly regularly; the Current version of this guidance is R6 was effective in January 2019 and the draft R7 guidance was issued on July 16 and is open for comments until September 16, 2019. The updated versions detail what has changed in the last 3 versions in a revision history at the beginning of the document, but are pretty similar in content otherwise. They point to the master eCTD page and its references and links for additional information, where you can read more about the program and stay up to date on the current guidance (the topic of my next post in the series).
Reach out to me if you want to know more or discuss your medical product development challenges.
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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 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
Electronic Regulatory Submissions Part 14