Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format with the initial IND submission. However, since FDA assigns a Pre-IND number, which ultimately becomes the IND number, and Module 1 includes at least two places that are appropriate for including Pre-IND documents (either Module 1.12.1 or Module 1.6 for meeting-related documents), we should be able to make these submissions in eCTD format as well. Doing so would allow us to ease into the use of eCTD format, which would be especially useful when working with sponsors who are new to the eCTD format.
So, I recently asked the CDER Electronic Submissions team if it is possible to make Pre-IND submissions in eCTD format. As usual, I received a quick and helpful reply to my query, this time from Regulatory Information Specialist Valerie Gooding.
“Yes, it is possible to submit Pre-IND correspondence in eCTD format.”
She noted that the submission type in the Regional Metadata should be set to “Presubmission,” for any Pre-IND submissions. The initial IND that eventually follows follows should be set as the “Original Application,” regardless of the sequence number.
She confirmed that all Pre-IND meeting-related correspondence should be included in the appropriate Module 1.6 subsections instead of Module 1.12.1
I also asked about how to deal with the FDA forms. Pre-IND submissions don’t require a Form FDA 1571; however, the ESG uses the information in the form to automatically process your submission. A submission without a form will generate a validation error at best, and could cause a rejection of your submission at worst. She recommended that we include a completed but unsigned 1571 in Module 1.1 to help ensure that the submission is processed without problems.
Finally, it’s important to remember that paper copies of your Pre-IND briefing document will still be required, even if you submit the Pre-IND documents in eCTD format. The letter granting your Pre-IND meeting will specify the number of paper copies that you’ll need to send in.
UPDATE (08 December 2011): I received an email from a colleague at a major biopharma company who noted that in three recent Pre-IND meetings with two different FDA review divisions, the Regulatory Project Manager did not require paper copies of the meeting package to be provided. This seems to be a policy that varies by review division, as I’ve not encountered this on some of our recent Pre-IND meetings. However, it is certainly encouraging to see FDA moving away from paper, and let’s hope that this is a trend that continues to spread throughout FDA.
- Transitioning from Paper to eCTD (theectdsummit.com)
- Health Canada Increases Acceptance of eCTD Electronic-only Filings (ask-cato.com)
- Multiple eCTD Sequences in One Day? (ectdtips.com)