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The New Module 1

June 4, 2015 | BJ Witkin, Senior Manager | Regulatory Operations

This year at the recent DIA eRegulatory and Intelligence Conference there were, as usual, a few major themes discussed. One of the biggest themes was the new module 1 (m1) specification (called DTD 3.3) announced by FDA.

The new m1 has a lot of implications for people throughout pharma—regulatory, commercial, publishing, and even software vendors, who will have to update publishing tools and viewers to allow for the changes.

Important points for the new Module 1

  • FDA will start accepting submissions with the new m1 spec on June 15, 2015 (that’s soon, folks!). It is optional unless you want to do grouped submissions and/or promotional material submissions via eCTD (see the next two bullets).
  • Sponsors will be able to submit grouped submissions, ie, one submission which goes to multiple applications. The intent seems to be mostly for promotional materials (see next bullet), but FDA wants sponsors to be creative. Maybe this will let a single CSR be submitted to multiple INDs if there’s more than one for the same compound?
  • The new spec allows for eCTD submissions of promotional materials, both direct-to-consumer (DTC) and healthcare professional (HCP). These will be placed into Section 15 of the new m1.
  • There are new, enhanced metadata, including the sponsor’s D-U-N-S number, and both a technical and regulatory contact for each sequence.
  • New validation criteria—as you’d expect with these changes to metadata and structure, there are also changes to the validation criteria.
  • Once an application switches to DTD 3.3, it cannot switch back.

With all these changes—and they’re significant—you’ll have to work with your software vendor(s) to ensure everything is ready for this upgrade.

Are you ready for the upgrade?
Your publishing tool will have to accommodate the new specification. Then your validation tools (you’re using more than one, right?) have to check the new validation criteria. Finally, your eCTD viewer has to support the grouped submissions and new backbone.

In case you’re wondering, FDA did state that their internal validation software and viewers will accommodate the new m1.

That being said, should you even switch?
First, you should probably wait. Although FDA did work with industry to do some testing, only seven sponsors signed up for the program. That’s obviously not a lot of testing. Let’s see how things go for other companies before you make the jump.

Second, the major advantages seem to apply only if you have a marketed product (so you can submit promotional materials) or if you have multiple applications for the same compound (grouped submissions). If either or both of these situations are true in your case, then it makes sense to upgrade.

Want to learn more?
The slide shows from the three FDA presenters are now available from FDA’s site. Their presentations have a lot more detail about the new m1 as well as information about coming upgrades to the ESG.

I hope you found this helpful. Watch this space for my next blog post from the conference which will summarize the “Ask the Regulators” session. I had the chance to ask the FDA some burning questions and I was very pleasantly surprised by their responses.
beej

Category: Regulatory Operations
Keywords: New module 1, eCTD 3.3, DIAeRI, grouped submissions, promotional material submissions

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