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FDA Unveils New Changes to eCTD Submission Formats

Posted 14 February 2014 | By Alexander Gaffney, RAC

If you weren't paying attention closely late last week, you might easily have missed a small but important announcement made by the US Food and Drug Administration (FDA). By the end of 2014, it says, it expects to be able to receive submissions referencing version 3.1 of the electronic Common Technical Document (eCTD)-a change that will primarily affect regulated pharmaceutical marketing.

Pharmaceutical Marketing Changes

The announcement, made on its eCTD Validation Specifications webpage, refers specifically to Module 1 of the eCTD, which is used to communicate un-harmonized administration and prescribing information about a drug. Modules 2, 3, 4 and 5 are all used to transmit harmonized information between regions which utilize the eCTD (the US, EU and Japan). Module 1, by contrast, is meant to convey information for each of those respective regions on an individual basis. It is, in other words, the one part of the eCTD meant to include that which cannot be harmonized.

FDA said it plans to give industry at least 30 days' advance notice before implementing the changes, known as Module 1 Specifications 2.3.

The "minor changes … reflect the re-designation of 'Prereview of television advertisements' from 503B to 503C," FDA explained in a statement. "Since adoption of the eCTD standard, it has become necessary to update the administrative portion of the eCTD (Module 1) to reflect regulatory changes, to provide clarification of business rules for submission processing and review, to refine the characterization of promotional marketing and advertising material, and to facilitate automated processing of submissions."

"The eCTD heading, ' Promotional materials submitted pursuant to section 503B' is being changed to, ' Pre-dissemination review of television ads,'" FDA added.

The changes are expected "by the fourth quarter 2014," FDA said.

Other Changes

In addition, FDA said it has published "revised final versions" of four eCTD documents:

  • "The eCTD Backbone Files Specification for Module 1," version 2.3 (which includes the U.S. regional document type definition (DTD), version 3.3);
  • "The Comprehensive Table of Contents Headings and Hierarchy," version 2.3
  • "Specifications for eCTD Validation Criteria," version 3.1
  • "Example Submissions using eCTD Backbone Files Specification for Module 1," version 1.3. 

Technical files supporting those documents are also available, FDA said.

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