eCTD Tips – Transitioning from Paper To Electronic Submissions

eCTD Tips – Transitioning from Paper To Electronic Submissions

April 9th, 2013 // 3:50 pm @

April 9, 2013

We find that the successful adoption of the eCTD format means that you need to have the proper strategic assimilation of the proper people and the proper technology. And FDA has been busy the last few years promoting the many virtues of submitting documents electronically. As of 2012, about 70% of new drug applications and 40% of new INDs were provided to FDA by electronic submission.

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But if you already filed your NDA or IND with paper how do you switch from paper to the eCTD format? The good news is that there are some fairly simple things you can do to convert your application to electronic form. Here are some simple steps:

#1 Check With Your Project Manager at FDA

Before you start this process, it is a good idea to contact your RPM at the agency and tell him what you intend to do. A good relationship with your RPM is very important to making this conversion process a smooth one! Your RPM is probably going to be happy to hear you are switching to an eCTD and will strongly support you. Note that every review office at FDA has its own little quirks or peculiarities, so you should always ask if there are any special concerns they have about your conversion to eCTD.

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#2 Submit Your Final Paper Submission

You will need to file one final piece of paper to your application. This will just consist of a brief cover letter and Form 1571. You will want to say something like this in your cover letter:

The purpose of this document is to notify your office of our intent to submit all future drug submissions in the eCTD format via the Electronic Submissions Gateway. At this time, IND/NDA XXXX has been provided in paper format. After this letter, all submissions to IND/NDA XXXX will be provided in the eCTD format.

#3 File Your Initial Electronic Submission

To do this, you will need to be prepared technically to put together and submit an eCTD submission. You should be working with a good eCTD vendor, or you will have the needed software and personnel in your company. You also need to have an ESG account with the FDA, and you will need to have made a test run submission to CBER or CDER to make sure that your submissions are acceptable to their standards.

It is a good idea to provide your first electronic submission from 3-5 business days from your last submission by paper. This will ensure you that FDA received/processed your last submission by paper.

Your initial submission by eCTD should consist of just a cover letter and Form 1571. You should state something like this:

We are referencing IND/NDA XXXXX amendment SN yyyy, which was submitted by paper on DATE. This notified FDA of our intent to provide all submissions in the future to IND/NDA XXXX in electronic format via the ESG. This submission is the first submission to IND/NDA XXXX in electronic format.

And with that, your drug submission is now in electronic format.

Other Things to Think About

We often hear people ask if you have to resubmit all documents that you gave in paper form. The good news is, no! FDA does not mandate this. But, you may find it helpful to provide some previously submitted documents in electronic format. This will help your FDA reviewers, which helps you.

If you want to turn in a protocol amendment as an initial eCTD submission, you probably submitted earlier the investigator’s brochure (IB) and the protocol original in paper format. When you are submitting the protocol amendment, we recommend you resubmit the IB and also the original protocol just so FDA reviewers have an easier time with it. They can just reference the documents that were submitted before in eCTD, and not have to get the paper submission from archives.

We think it is a good idea in this case to stamp in the IB footer, Previously Submitted in Paper. You also may want to add in your cover letter tat these documents were submitted in paper form, and the new electronic versions do NOT differ from the paper copies.

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Please take a look at our upcoming Webinar on FDA’s eCopy, which is causing a great deal of confusion in electronic submissions to FDA.

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