The US FDA is rolling out a new and improved Module 1 in less than three weeks. Are you ready? Here is a regulatory intelligence primer based largely on the information that was divulged at the recent DIA eRI conference in Philadelphia.
1. The US FDA will begin accepting eCTD submissions using the new Module 1 specifications (DTD 3.3) on Monday, June 15, 2015.
2. Using the new Module 1 is optional with a few exceptions. If you plan to submit promotional and advertising materials to CDER OPDP and/or use grouped submissions, you must use the updated specifications.
3. Once an application is converted to the new M1 specifications, you cannot return to an older version.
4. Metadata in the new Module 1 is more robust. The FDA is collecting some of this data now for future initiatives. The DUNS number won’t impact eCTD submissions validation just yet, but is useful to the Agency in the context of mandatory reporting of facility information. Supply the DUNS number of your corporate headquarters.
5. FDA is asking sponsors to include regulatory and technical contacts with each submission. Inclusion of this 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.
6. Updated validation criteria will be phased in as part of the Module 1 update. Validation will affect grouped submissions and promotional and advertising submissions.
7. Technical rejection of grouped submissions. A rejection for any reason will lead to rejection for all applications in the group.
8. Grouped submissions can be “ungrouped” at any time.
9. Be aware of the forms you include in CDER OPDP submissions. Submit only Form 2253 for Promotional labeling and advertising submissions. These submission types do not require a 356h Form.
10. No retirement date for us-regional DTD v2.01 has been set.
11. Sponsors are encouraged to participate in evolution of grouped submissions. 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. There is such a thing as a bad idea.
12. FDA is accepting test M1 submissions. As of DIA eRI 2015, 7 individual sponsors/vendors had participating, submitting 50+ sequences
13. Visibility of Grouped Submissions could be challenging and largely depends on your review tool. The FDA’s own review tool has been updated to support the rollout of Grouped Submissions.
14. Only one sequence in the Grouped Submission contains physical files. The FDA is referring to this sequence as the “true” sequence or application. The XML displays as Sequence Containing Files=True. The “true” sequence is the only sequence that can be uploaded to the ESG.
15. A submission-id is assigned to the first sequence number of each “new” regulatory activity. The submission-id will remain constant (ex: sub ID 1004) to group submissions together into their specific regulatory activity. Sponsors now have the ability to relate pre-submissions to applications using the sub ID and sequence structure.