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FDA’s New Module 1 is a Bridge to eCTD 4

Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group that developed the Regulated Product Submissions (RPS) standard. This post is the third in a series on the Next Major Version (NMV) of eCTD, eCTD 4, which is based on the RPS standard.

The evolution of the Electronic Common Technical Document (eCTD) has been a progression. More features and functionality become available to users as new versions are introduced. User adoption of eCTD also increases year over year.

FDA Module 1 v2.3 (DTD 3.3) is a bridge to eCTD 4. A number of functionality enhancements set for inclusion in eCTD v4 first appeared in the new FDA M1 but were not present in FDA eCTD M1 (DTD 2.01).

The shared features, presently implemented in FDA M1 v2.3 (DTD 3.3) and included in eCTD 4, are coded metadata, in the form of Controlled Vocabularies, and Grouped Submissions.

As I’ve stated previously, the implementation of eCTD 4 will not be a big change in the way your eCTD software tools work. The software will simply give users the functionality to take advantage of new features like Grouped Submissions.

Controlled Vocabularies

The upgrade to FDA M1 v2.3 (DTD 3.3) enabled receipt of Advertising and Promotional submissions at both the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) in eCTD format.

More descriptive metadata was also a part of the M1 upgrade and gave sponsors the ability to more accurately classify the types of promotional materials they were submitting and the intended audience.

When building an M1 v2.3 (DTD 3.3) Ad Promo sequence, regulatory professionals could choose Consumer or Professional as the Audience Type. Each selection is tied to a code. For example, Consumer Audience Type is us_promo_material_auidence_type_1. These codes are specified regionally by regulators such as the FDA and European Medicines Agency (EMA).

While there are only two (2) choices for US Promotional Material Type, there are 46 codes for US Promotional Material Type that span the conventional (Direct Mail, Print Ad), digital media (Website, Mobile), and even old world (House Organ).

More metadata and more codes will be introduced as part of the FDA’s implementation of eCTD v4 including US FDA Category Event (to support two-way communication), US Media Type, Regulatory Review Time, and US Regulatory Status. You can see these codes and categories for yourself by downloading the US FDA Module 1 Implementation Package 1.0.

Point being, these Controlled Vocabularies (CV) are foundational to eCTD v4 and first appeared in FDA M1 v2.3 (DTD 3.3). Vendors who correctly implemented the new M1 have already done the heavy lifting in terms of development.

Grouped Submissions

Grouped Submissions is another concept that made its debut when FDA began accepting eCTD M1 v2.3 (DTD 3.3) submissions on June 15, 2015. The concept will boost productivity by eliminating redundancies and is a major feature of eCTD v4.

Grouped Submissions, in eCTD v4 language, eliminates the need to submit multiple, identical submission units to different applications. The FDA eCTD v4 Implementation Guide v1.0 states, “All contents in the Submission Unit relate to all Submissions in the Submission Unit.”

The FDA eCTD v4 Implementation Guide v1.0 provides a real world example of a Grouped Submission for a Labeling Supplement. Labeling Supplement contents are submitted to NDA 456789, NDA 567890, and 678901. Remember, as was the case with M1 v2.3 (DTD 3.3), if metadata combinations do not agree, a validation error is triggered. In this example, all submissions have the same application code (NDA, us_application_type_1) and the same submission code (Labeling Supplement us_submission_type_4).

Taking the example further, the sponsor submits an amendment to the previously submitted grouped Labeling Supplement. Remember, with a Grouped Submission, lifecycle operations on files affect all applications in the group. Guidance released for the rollout of M1 v2.3 (DTD 3.3) notes that Grouped Submissions can be ungrouped at any time.

The one instance where content doesn’t need to be the same for Grouped Submissions, and it applies to new FDA M1 and eCTD v4, are the FDA forms that should accompany each submission.


Controlled Vocabularies (CV) and Grouped Submissions, two concepts integral to the implementation of eCTD v4 not just at FDA, but at other agencies such as the EMA, were already rolled out as part of last year’s FDA M1 update. For vendors who have correctly developed and implemented the new technology, the climb to eCTD v4 is not that steep. Simply put, the enhanced standard will introduce new features and functionality. Sponsors already submitting Ad Promo and Grouped Submissions will also have a head start in using the new technology to its full advantage.

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By: Jason Rock

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