Darryl Clarke

FDA begins accepting eCTD submissions with the New Module 1 version 2.3

Darryl Clarke

On June 15th 2015 the FDA started accepting eCTD submissions with the new Module 1 version 2.3, though it will not be mandatory till 2017.  Some of the benefits to industry will be, an updated Comprehensive Table of Contents with more granularity and more clarity in headings. The ability to submit grouped submissions, this will save time and effort by allowing one submission to multiple applications that share the same information. The FDA expects sponsors to invent creative and unexpected uses for grouped submissions. The Agency is open to creativity that advances the intent of grouped submissions. Ideas would likely be shared through non-binding technical guidance as best practices. The opportunity to streamline the FDA Form 2253 submission process and submit Advertising and Promotion submissions in eCTD format through Electronic Submission Gateway (ESG) is now available.

How many companies are ready to submit their 2253 submissions with the new Module 1? Will this be a long transition for most companies?

Using the new Module 1 is optional, unless you wish to send in a grouped submission or an advertising/promotional material submission electronically. Once an application uses the new version, you cannot go back to the old format.
There are also benefits to the FDA with the new Module 1, the ability to accept FDA Form 2253 and non FDA Form 2253 submissions in eCTD format via the ESG. Product application information is in one location, will be quickly available for all reviewers as needed. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) submissions now more closely aligned

Here are some of the changes to the Module 1 Version 2.3. The Document Type Definition – (DTD) has a few new elements, Application Set, Application ID (this will be the products D-U-N-S (Data Universal Numbering System) number, Application contacts and Submission Description. Regulatory and technical contact information will help to alleviate communication headaches and help eSubs support identify the appropriate contact for submission issues. For example, the technical contact should be prepared to discuss eCTD publishing and processing errors. There are also some new terms including Grouped submissions, Regulatory Activities and Attribute list. With the new terms there are also some terms removed. Date of submission, Product Information, related sequence number and the UTIL folder has also been removed.

How many companies will start using the new Module 1 for all submissions? Or will most companies wait till it becomes mandatory?

This is just another step as the industry moves toward the ICH eCTD 4.0. It is still another few years before eCTD 4.0 will be rolled out but this new Module 1 version 2.3 will help prepare the industry for the future changes.