This being the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for the submission of Type III Drug Master Files (DMFs) in electronic Common Technical Document (eCTD) format. With the deadline extended till May 5, 2020, the prime question every applicant should think about is what the requirements of DMF Type III are and how is the data developed, validated and published accurately for successful electronic submissions. All DMFs in this format submitted after the deadline will be rejected.A re-submission in the eCTD format is not required if a DMF is already present in pen and paper with the FDA. However, once the new target date has passed, all fresh submissions, as well as any amendments, supplements, and reports concerning existing Type III DMFs are to be submitted in the same eCTD format. The same DMF numbers will be held by the DMF holders as before, with only minimal changes. For instance, if previously the DMF number was 5678, the DMF holder would now have to add two zeros at the beginning. Thus, 5678 would change into 005678, when the DMF gets converted to its eCTD format; but would basically remain the same number.

PLACE CONFIDENTIAL DATA IN TYPE III DMF

In case of any confidential data, or if the manufacturer desires to retain certain proprietary information from the applicant or sponsor, all such details may then be enlisted in a Type III DMF and included in the application, complemented by an authorizing letter from the manufacturer.

ANNUAL UPDATION OF DMFs

The DMF Guidance recommends the DMF holders to update their DMFs annually. If the DMF has not been updated regularly in the past three years then FDA sends “Overdue Notice Letters” (ONLs) to DMF holders. In case of failure to respond to an ONL DMF by a holder then his/her DMF may be closed by the FDA.

Often compiling, validating and publishing the data of a DMF becomes difficult despite proper knowledge of the regulatory updates when you do not start preparing for submissions before time. Moreover, if your present DMF is in paper format then transforming it into an eCTD would be really difficult, keeping in mind the deadline and the pace at which you need to work. Start now to be on track.