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eCTD Module 1 Specification Reminder

In less than two weeks, the US FDA will no longer be accepting the eCTD Module 1 specification v1.3 (US regional DTD v2.01).

According to the FDA’s Data Standards Catalog, the US Module 1 specification v1.3 (US regional DTD v2.01) will no longer be supported as of March 1, 2022. Effective on this date, all US eCTD applications must follow the US Module 1 specification v2.5 (US regional DTD v3.3) to pass validation.

Differences between v1.3 and v2.5 of the specification include the ability to submit grouped submissions (for certain submission types), as well as Ad Promo submissions.

The WAYS team is transitioning client submissions to the new specification so feel free to reach out if you have questions about the new version of the specification or what it means for your next submission.

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