Submissions metrics for the US FDA’s new Module 1 shared with industry at the DIA RSIDM 2016 Forum paint a picture of modest activity for the enhanced specification. As of February 1, 2016, 117 companies submitted a total of 1,639 sequences of varying application and submission types.
Investigational New Drug (IND) applications, which aren’t required in eCTD format until May 5, 2018, led the way with 836 total sequences. The Agency received 140 Drug Master File (DMF) submissions. eCTD DMFs are mandatory as of May 5, 2017.
Promotional Labeling & Advertising submissions ranked second in volume (314 sequences) for activity by submission type. Implementation of the new M1 stipulated that eCTD Ad Promo submissions to CDER must use the v2.3 specification. Again, the data is for the period up to February 1, 2016.
M1 v2.3 introduced the submission id concept used to relate sequences to regulatory activities, a submission sub-type (based on application type and submission type), contact information (technical and regulatory), DUNS number and supplement effective date.
New submission types and metadata were added in the Ad Promo section. For example, a sponsor is now able to select consumer or professional as the promotional material audience type.
Grouped submissions is another major element added in the new M1 v2.3 specification. Functionality for grouped submissions allows a sponsor to re-use documents and submit one-to-many. The concept will be extended to Modules 2-5 when eCTD v4.0 is implemented. At the 6-month mark, only 3 successful grouped submissions were filed to the FDA and the Agency has not released more current data.
FDA began accepting submissions built on the v2.3 specification (DTD 3.3) on June 15, 2015.