(Note: This post is part of a multi-part series on the CTD this fall)

The eCTD guidance is one of the very few that specify requirements for applicants; most include a statement that the guidance represents the agency’s current thinking and are not binding on any party. Under eCTD guidance, most types of submissions must be made electronically in order for them to be accepted by the divisions.

Section 745(a) of the FD&C Act requires that submissions under section 505(b), (i), or (j) of the FD&C Act2 and submissions under section 351(a) or (k) of the Public Health Service Act (PHS Act)3 be submitted in electronic format specified by the agency beginning no earlier than 24 months after FDA issues a final guidance specifying an electronic submission format. These sections refer to the following types of submissions to CDER/CBER:

1. NDAs
2. ANDAs
3. BLAs
4. Commercial IND applications (for products that are intended to be distributed commercially)
5. All subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect
6. Master files, such as DMFs, which are considered to be submissions to an IND, an NDA, an ANDA, or a BLA

According to the eCTD web page, electronic submission standards will be optional but encouraged for the following categories:

1. Noncommercial INDs, such as investigator-sponsored INDs and expanded-access INDs
2. Submissions for blood and blood components, including source plasma
3. Submissions for promotional materials for human prescription drug

What’s the current guidance, you ask? We’ll discuss that in my next post in the series. Meanwhile, read more about the program at the main eCTD web page.

Reach out to me if you want to know more or discuss your medical product development challenges.

katrina@krogersconsulting.com

linkedin.com/in/katrinarogers

https://calendly.com/katrinarogers

Text Copyright © 2019 Katrina Rogers

Follow the links below to read each part of the series.

Electronic Regulatory Submissions Part 1

Electronic Regulatory Submissions Part 3

Electronic Regulatory Submissions Part 4

Electronic Regulatory Submissions Part 5

Electronic Regulatory Submissions Part 6

Electronic Regulatory Submissions Part 7

Electronic Regulatory Submissions Part 8

Electronic Regulatory Submissions Part 9

Electronic Regulatory Submissions Part 10

Electronic Regulatory Submissions Part 11

Electronic Regulatory Submissions Part 12

Electronic Regulatory Submissions Part 13

Electronic Regulatory Submissions Part 14

Electronic Regulatory Submissions Part 15

Electronic Regulatory Submissions Part 16