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Dispelling Misconceptions: Converting from Paper to eCTD Submissions

May 23, 2017 | B J. Witkin, Senior Manager | Regulatory Operations

Over the years I’ve heard a whole bunch of misconceptions and misunderstandings about making the change from paper submissions to eCTD. Since the deadline to convert NDAs, ANDAs, and BLAs has recently passed (May 5th, 2017) and the deadline for INDs and DMFs is now a little less than a year away (May 5th, 2018) I thought I’d address some of them.

Rumor has it…

Here’s a list of some of the many rumors, myths, and alternative facts I’ve heard about making the switch to electronic submissions:

  • You have to do a final paper submission announcing you’re switching

    Doing a stand-alone submission announcing the change is unnecessary, though you can mention it in the cover letter of your final paper submission if you’d like.

  • Your first electronic submission has to be a stand-alone submission announcing you’ve made the change (I often hear this one in conjunction with the previous one)

    Same as above. Doing a stand-alone isn’t required but if you feel like doing one, or including a statement in the cover letter of your first eCTD submission, it won’t be a problem.

  • You have to resubmit all your previous paper submissions

    Absolutely not! You can resubmit documents if you think it’s truly helpful for the FDA reviewer—good examples would be CMC documents or protocols so you can more easily lifecycle them going forward—but you should make it very clear in the cover letter that the information has already been submitted and is simply being provided for the reviewer’s convenience.

  • Your first electronic submission must be an annual report

    Considering that the deadline is May 5th, you’ve probably already realized that this wouldn’t be reasonable. However, the us-regional.xml for your first eCTD submission has to be coded as “Original Application.” If you don’t label it as “Original Application” you’ll get a validation warning for almost every submission thereafter (but you can ignore the warning).

  • You must do a “pilot submission” to show that you’re ready to go electronic

    It’s not required but if you’re doing your own publishing (remember I don’t think that’s cost-effective) you probably should, just to get a technical check of your work. This eCTD pilot is different from the ESG pilot and it doesn’t go to your FDA reviewer. Instead you’d send it to the e-subs group.

  • You should restart your sequence numbers at 0000

    Absolutely not. If you’re submitting using eCTD v2.01, you should just continue your sequence numbers from the last paper one. If you’ll be using eCTD v3 sequence numbering it gets a little more complicated, more complicated than I want to get into here. Hmmm, maybe there’s another blog post…

  • If submitting electronically is too difficult you can always switch back

    No.

If you’re reading those first two bullets and saying, “That’s the way we’ve been doing it!” or “I thought those were required!” you should feel better knowing that they were standard practice until a few years ago, back when eCTD was still in its infancy. Now that eCTD has become more commonplace and the knowledge base is larger, FDA is no longer expecting or requiring those extra submissions.

FDA also has a short FAQ video addressing several of these misconceptions.

OK, what SHOULD we do?

To borrow a line from a famous sneaker company:

Just Do It.

You don’t need to tell your reviewer that you’re making the change, and for INDs you can make the switch at any time (at least, prior to May 5th 2018!), so just go ahead and do it. Feeling overwhelmed? I’ve got a couple of useful posts back in my series on Electronic Submissions for Paper People:

Of course, there’s a lot more to making the change than just saying, “OK, we’re going to eCTD next week!” If you have questions, or don’t even know where to start, all of us here at IMPACT would love to help you. Don’t hesitate to contact us!

Category: Regulatory Operations
Keywords: paper INDs, eCTD mandate

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