GlobalSubmit: Transitioning from Paper to eCTD

Successful adoption of the eCTD involves the strategic assimilation of the right people and the right technology. It requires a clear understanding of the processes and best practices that ensure success. To provide some key insights into eCTD publishing, we asked Evan Richardson, Associate Director of Regulatory Operations, Cato Research to author today’s guest post.

For several years, experts from both industry and FDA have extolled the virtues of eCTD submissions. The message is clearly sinking in; FDA reports that almost 70% of new NDAs and 41% of new INDs are now submitted in eCTD format. There are obviously many benefits to switching from paper to eCTD submissions, but how do you take advantage of them if you’ve already filed your application in paper?

Fortunately, it’s relatively simple to convert your application from paper to eCTD. I’ll use an IND as an example in my explanation below, but the process applies to NDAs or BLAs as well.

Step 1: Check-In with Your FDA Regulatory Project Manager

Before beginning the conversion process, I recommend that you call your assigned Regulatory Project Manager (RPM) at FDA and let him or her know what you’re planning. A close and cordial working relationship with your RPM can be an invaluable asset, and I think it’s always a good idea to keep him/her apprised of any major submissions on the horizon. Almost certainly, your RPM will be very pleased to hear that you plan to convert to eCTD and will offer their blessing on the endeavor. Each FDA review division seems to have its own quirks, so you should also be sure to ask if there are any special concerns that you should keep in mind, just in case.

Step 2: File Your Last Paper Submission

You’ll file one last paper submission to your IND. This submission will consist of only a cover letter and a Form FDA 1571. In the cover letter, you should include a statement similar to the following:

The purpose of this submission is to notify the Division of [Sponsor]’s intention to submit all future submissions to IND xxxxxx in eCTD format through the Electronic Submissions Gateway (ESG). Currently, IND xxxxxx is submitted in paper format; henceforth, all submissions to IND xxxxxx will be in eCTD format (beginning with SN 0000).

(Note the reference to “SN 0000” in the last sentence. I’ll discuss this further later on.)

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