In recent years, the electronic Common Technical Document (eCTD) has become the application type of choice for regulatory professionals operating in the US, EU, Japan and many other markets, offering them a relatively straightforward way to file small variations on a single application to multiple regulatory bodies. Now the US Food and Drug Administration (FDA) has announced the publication of final versions of several documents outlining specifications used in the eCTD's backbone files.

Background

The eCTD is built on a machine-readable format known as extensible markup language, more commonly known as XML. This format allows a wide variety of programs to read the same data, but requires the XML to be formatted according to certain specifications.

FDA periodically updates its eCTD documents, typically to expand what information is allowed to be submitted under the XML schema. For example, an April 2013 update allowed the submission of limited media content in eCTD applications, while an earlier February 2013 update permitted limited information about related medical devices.

New, Minor Changes

Now FDA is out with several new eCTD updates, including changes to three documents:

• The Comprehensive Table of Contents Headings and Hierarchy (Version 2.2)
• The eCTD Backbone Files Specification for Module 1 (Version 2.2)
• Specifications for eCTD Validation Criteria (Version 3.0)

So what's new? Mostly minor or cosmetic changes, FDA explained in an accompanying Federal Register document. For example, headings for several sections have seen changes, which required changes to be made to the Contents Headings document.

In all, FDA said, most of the main changes had already been proposed in February 2013, part of a "major update" to Module 1 (i.e. the region-specific module) of the eCTD. The new changes, FDA added, are revisions to the February update.

Files submitted using the eCTD Module 1 specification (Version 2.2) will be accepted by FDA starting in June 2014, and the agency said it will give at least 30 days advance notice to industry before the changeover.

Federal Register Document

eCTD Important Notices