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May 20 2014

FDA’s New Module 1

Jessica Long, Regulatory Associate/Submissions Specialist

In February of 2014, FDA provided an update to the implementation of the revised Module 1 for eCTD submissions on the heels of a few last-minute modifications. Currently, FDA plans to begin accepting submissions with the new Module 1 in Q4 of 2014. As a more definite timeline seems to be looming on the horizon, let’s take a quick look at the types of changes in this update, as well as the implications for both new and existing eCTD applications.

There are some misconceptions in the industry that FDA has merely added a few more headings into the eCTD hierarchy within their Module 1, but while that has certainly been the case, FDA has also made some pretty substantial changes to the eCTD Backbone Files Specification and the supportive files. The revisions will assist CDER’s Office of Prescription Drug Promotion (OPDP, formerly DDMAC) and CBER’s Advertising and Promotion Labeling Branch (APLB) in their review of promotional material. The updates will also allow greater flexibility for change in the future and ensure compliance with ICH eCTD 4.0, which has not yet been released for implementation.

In a public presentation provided by multiple FDA representatives in September of 2012, Marci Kiester, Associate Director of OPDP explained that her division’s reviewers had been unable to reap the many benefits of eCTD because of some internal technology issues, but also a lack of granularity with regard to Section 1.15 Promotional Material. The current update will provide that granularity, as well as utilize attributes to better categorize the files that are typically sent to OPDP for review. For more detail about the updates to Section 1.15, please see the new Comprehensive Table of Contents Headings and Hierarchy.

The more interesting change to the new Module 1 is some criteria to allow for grouped submissions, which are single submissions to multiple applications that occur simultaneously. This can now be accomplished through FDA’s addition of ‘application set’ to the administrative data of the submission. There are some occasions for which it is necessary to submit the same information to multiple applications, be it a Development Safety Update Report (DSUR) that applies to multiple NDAs, or promotional materials that list multiple products for a particular company.

There are a few implications for the management of life cycle operations with grouped submissions and FDA recommends that the first set of files all be submitted with the operation of ‘new.’ Subsequent submissions can use the ‘replace’ feature to update documents previously submitted, but replacing those documents for one application will replace them for all applications. There are some methods for ‘ungrouping’ these submissions, but a company would be wise to use caution with grouped submissions, as this is an optional feature that can be very helpful, but also requires careful planning to ensure a clear and organized life cycle. FDA was careful to mention that grouped submissions will not eliminate the need for Section 1.4.4 – Cross-reference to Previously Submitted Information.

Another fresh update to Module 1 includes some additional attributes for the XML itself, as provided by the DTD and stylesheets and the updated validation criteria that is sure to follow. Some of the more exciting attributes allow for the input of regulatory contact information, including a spot for a technical contact or U.S. agent; submission sub-types; supplement effective dates; form types (no more pesky Form FDA 3674 in Section 1.2); and more.

A final word about these changes – while transition to the new Module 1 is optional, once the transition is made for a particular application, there cannot be a transition back to the old format. Subsequent submissions must also be completed in the new Module 1, so companies should discuss this with any publishing vendors to ensure they can continue to compile submissions in their preferred format.