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Electronic Submissions for Paper People – eCTD Metadata…Why is my publisher asking me for all this?

July 30, 2015 | BJ Witkin, Senior Manager | Regulatory Operations

In my two previous posts I’ve talked about the content of an eCTD submission and the tools needed to create one. Now let’s talk about what a publisher needs in order to start a new eCTD application (IND, NDA, MAA, etc). (I warn you in advance, this post is pretty technical. If you’re not into knowing what goes on behind the scenes, you might want to skip this post!)

When we start publishing an application for a sponsor, the first thing we ask them for is a whole bunch of information about their compound—drug substance name, manufacturer, dosage form, indication, etc.

We publishers call that information metadata.

What do we do with all that metadata and why do we need it?

The publishing tool uses metadata to create the XML files and the folder structure for the application.

In the figure below, the top left image is part of the index.xml file (the file telling the Viewer what’s in the submission) for an initial IND; the image on the right is the underlying folder structure, as viewed in Windows.

The bottom left image shows how the metadata look in the Viewer.

OK, so why does this matter to you?

  1. Be prepared: When you make the switch to electronic submissions you should expect your publisher to ask you for a lot of information. At a minimum, you should be able to provide this:PreparedIn addition, if you’re changing publishing vendors or switching from paper to electronic you might also be asked for:AppHere at IMPACT we ask each new sponsor to complete a spreadsheet asking for all of this information.
  2. Think ahead: Let’s say that you start your IND with a drug product strength of 40mg. After a few studies you change to a strength of 20mg. Each time you change strengths the publishing tool will build a new folder structure, and eventually your IND’s structure will become unwieldy and hard to view (this also applies each time you change manufacturers or dosage forms).
    An experienced publisher will have taken this possibility into account and built the initial IND with generic values. For example, we often list the strength and manufacturers as “All” in case these change. 

    You should check with your publisher at the start of each new project, or when you’re selecting a publishing vendor, and ask them what his or her plan is for the application.

I know this post was technical, but I tried to keep it short and sweet! This is an area that actually causes a lot of confusion (and some conflict!) between publishers and regulatory affairs folks so we wanted to address it. My next post will be more applicable to regulatory affairs as we’ll discuss linking and lifecycle.

Category: Regulatory Operations
Keywords: eCTD metadata, index.xml, eCTD publishing, electronic submission

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