For the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for Type III Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format. With the deadline extended till May 5, 2020, the first and foremost question every applicant should ponder upon is, what are the DMF Type III requirements and how is the data built, validated and published accurately for effective electronic submissions. Post the deadline, all DMFs which are not submitted in this format will be rejected.

If a DMF already exists in paper format with the FDA, it doesn’t need to be resubmitted in the eCTD format. However, post the new target date all new submissions including any amendments, supplements, and reports pertaining to existing Type III DMFs will have to be submitted in the eCTD format. The DMF holders may continue to hold the same DMF numbers as before, with some minor changes. For instance, if the previous DMF number was 5678, the DMF holder would now have to pad left with two zeros. Thus, 5678 would be converted into 005678, when the DMF is converted into eCTD format; but would essentially remain the same number.


In case of confidential information, or if the manufacturer wants to withhold certain proprietary information from the applicant or sponsor, all such information may then be placed in a Type III DMF and incorporated into the application, accompanied by an authorizing letter from the manufacturer.


According to the DMF Guidance, DMF holders are recommended to update their DMFs annually. FDA also sends “Overdue Notice Letters” (ONLs) to DMF holders for DMFs that have not been regularly updated in the last three years. If a DMF holder fails to respond to an ONL, his/her DMF may be closed by the FDA.

Even with complete knowledge of all the Regulatory updates regarding DMFs, sometimes, compiling, validating and publishing the data would be a difficult task unless you start preparing for submissions before time. In addition, if your current DMF is in paper format, converting it into eCTD will be challenging especially while keeping pace against the extended deadline. Act now to be compliant.


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