Starting May 5, 2018, new master files and any submissions to existing master files such as amendments, annual reports and letters of authorization (LOAs)) must be submitted electronically through the FDA’s Electronic Submission Gateway (ESG) in electronic Common Technical Document (eCTD) format. 

Any submissions not submitted electronically in eCTD format after the May 5, 2018 deadline will be rejected. 

What you need to do?

If the current DMF is in paper format with FDA, a full resubmission in eCTD is optional. The requirement is for any new information that needs to be submitted from that point forward. 

There is no change in the DMF number, other than if the existing number is four digits, e.g., 1234, the DMF holder will need to pad left with zeroes to convert the DMF number to a 6‑digit format, e.g., 001234 when the DMF is converted to eCTD format.

In addition, if the DMF holder chooses to resubmit all of an existing paper DMF in eCTD format, and there are any changes in the content of the DMF as a result of the reformatting (e.g., addition of new or updated information), the Cover Letter for the submission will need to specify what areas of information have been updated.

For further information see FDA’s webpage for DMFs which provides details on the format, content and submission standards for master files.

ICON has extensive experience with assisting companies with Drug Master File submissions including an electronic publishing team with eCTD expertise and multiple accounts for ESG submissions.