What is the Electronic Common Technical Document?
(Note: This post is part of a multi-part series on the CTD this fall)
Since 2017/2018, CDER and CBER have required all applications, amendments, supplements, and reports be submitted electronically using the Electronic Common Technical Document or eCTD format. The eCTD is part of a broader set of data standards that the agency is developing to support more efficient science-based pre-market review of medical products, improve post-market review, and enable better communication among stakeholders. The medical products under eCTD are human use pharmaceuticals, and the eCTD applies to products in the Discovery, Application Review, and Post-Market Surveillance phases of their lifecycle. The legal requirement comes from section 745(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144). The eCTD program defines how the law will be implemented and administered in practice. In the next post we’ll discuss what submission types fall under the eCTD requirements.
You can read more about the Data Standards Program at this web site and view an interactive infographic on the various standards here. We’ll be discussing more about the eCTD program in upcoming posts, but for reference, here’s the main eCTD web page.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Follow the links below to read each part of the series.
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
Electronic Regulatory Submissions Part 14
Electronic Regulatory Submissions Part 15
Electronic Regulatory Submissions Part 16
Text Copyright © 2019 Katrina Rogers