The History of the CTD and eCTD
(Note: This post is part of a multi-part series on the CTD this fall)
The history of the ICH eCTD is shown in this ICH slide deck from 2011, a program overview presented by the Rapporteur (that’s the person appointed to report the proceedings of a group’s meetings) of the eCTD Working Group. The document shows how the efforts were regional on the 1980s-1990s and moved to ICH in 2004 when the Electronic Standards group (M2 in ICH parlance) started working with the CTD in 1997. The first version of the eCTD issued in 2003 and its been evolving ever since, though the deck only shows dates up to 2010.
The addition of the electronic format makes an application much easier to handle, illustrated nicely on pages 9 and 10 in this deck. The slides also show impressive rates of eCTD adoption in the US, EU, and Japan through 2010. This was even before the development of the current version 4.0. In my next post we’ll discuss the content of the individual CTD modules.
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 3
Electronic Regulatory Submissions Part 4
Electronic Regulatory Submissions Part 5
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