Question:
Can you please confirm the process for converting a paper IND to eCTD?
Response:
For transitioning to eCTD format from paper or non-eCTD format, the first submission would be coded according to the currently active regulatory activity.
If you are transitioning your unapproved original application, you would code the us-regional.xml file as "original-application" as the submission-type for the first submission with a detailed explanation in the cover letter.
If you are transitioning an approved original application, you would use "other" as the submission-type. If you are transitioning with the submission of a new supplement, you would use the appropriate supplement type (e.g. labeling supplement).
It's recommended that your transitioning eCTD sequence be
identified as a general correspondence submission in the cover letter and FDA
Form, stating the application will be submitted in eCTD format from this date
forward.
The FDA form should list the submission type as General
Correspondence (Other). The bold print on the top of the cover letter should
say the correct submission type (General Correspondence, Amendment, etc.).
In
the body or at the end of the cover letter, you could state the following:
"As per the advice received from Office of Business
Informatics, this eCTD submission sequence is intentionally being coded as
"other" in the us-regional.xml and serves as a first-level submission
type in the Electronic Common Technical Document (eCTD) format. This eCTD
sequence is intentionally being submitted as "other" to establish the
eCTD hierarchal structure and will allow second-level submission types such as
amendments and resubmissions to be related to it." You should adjust the
wording in your cover letter to match your specific situation.
If unable to submit a fully completed fillable form with an
electronic digital signature, it is possible to submit the complete fillable
form (not scanned) without the signature, along with a second 1571 form that
uses another method for signatures (e.g., a scanned signature).
When including a second complete 1571 form (it can be
scanned), do not include "1571" anywhere in the file name. We
recommend that you use a filename such as "signed-form.pdf" or
similar. The filled form should be named
"1571.pdf". This will allow our automated systems to correctly find
your fillable form, read it, and process your submission appropriately. The
project manager will be able to find your signed form near your filled form, in
the module 1 forms section of the eCTD.
Both of these forms should be placed in section 1.1.1 for eCTD
submissions.
