Finally, the Deadline for Mandatory eCTD Submissions

May 19, 2015 | Kathy Elks, RAC, Associate Director, Regulatory Operations | Regulatory Operations

In a previous post, the timeline for mandatory electronic submissions to the FDA was discussed. Within that post, we introduced the “mother” guidance, published in December 2014, which explained that it wasn’t feasible for FDA to describe and implement the electronic format of all submission types within a single guidance document.

General Guidance
The “mother” guidance outlined the submission types that must be submitted electronically, as well as exemptions from filing electronic submissions, waiver criteria, and the timeline and process for implementation.The guidance also explained that mandatory electronic submissions would begin no earlier than 24 months after issuance of a final guidance specifying an electronic submission format for a particular study type.

Please Tell Us When!
The December 2014 guidance addressed several questions from the industry but left the biggest question unanswered:

When would a final guidance be issued that triggered the 24-month clock for eCTD submissions?

At Last
On May 5, 2015, the guidance with the definitive dates for mandatory eCTD submissions was finally released. Now the industry has the answer that everyone had waited for so many years to hear.

And the Answer is…
The submission types and timelines for implementation are defined below:

Mandatory

Exemptions
The new guidance explains that under Section 745A(a) of the Food, Drug, and Cosmetic Act, Congress granted explicit authorization to the FDA to implement statutory electronic submission requirements within a guidance.

Within the boundaries of this law, FDA has exempted all non-commercial INDs from mandatory eCTD format. This includes investigator-sponsored INDs and expanded access INDs (eg, emergency use INDs and treatment INDs). Although exempt, FDA will graciously accept these submissions in eCTD format.

Coming Soon
Another noteworthy point that is mentioned in the guidance is FDA refers to a separate “eCTD Technical Conformance guide” that will be forthcoming. Stay tuned for release of this technical guide.We will also have a series of blog posts coming soon about electronic submissions, so stay tuned for those as well!

Need Help?
The migration to eCTD submissions doesn’t have to be a complicated process. IMPACT has a full service Regulatory Operations group that can help you as you prepare for electronic submissions.IMPACT can build your submissions in eCTD format and submit them to the FDA on your behalf. Or we can work with you and help you bring eCTD publishing capabilities to your organization.

Whether you have a quick question or you would like to discuss your specific needs in detail, please contact us or give us a call at (919) 899-9248.

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Category: Regulatory Operations
Keywords: Regulatory Operations, eCTD, mandatory eCTD, FDA guidance

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