Drug Master File Submission Process

We have discussed the types of drug master files and their purpose in the previous article now we will learn how a DMF is submitted to the FDA in short.

Procedure for DMF submission

• Electronic Common Technical Document (eCTD): DMFs must be submitted electronically in eCTD format.

1. Holder sends the DMF containing a cover letter, administrative information, and technical information to the FDA
2. Once received the central document is staff reviews the DMF for administrative information and then the DMF is entered in the respective database an identification number is assigned to it and a letter is sent to the DMF holder
3. If the holder does not receive any response from the FDA, then he can put a query at dmfquestion@cder.fda.gov.in
4. The letter sent to the holder by the FDA contains the assigned DMF number, type of DMF, and a reminder of any obligations if present.
5. The holder has to submit all changes if any as amendments
6. The DMF holder has to submit annual updates of any significant changes made to the DMF and if there are no changes, a confirming letter of same has to be submitted.

Note:  Letter of Authorization – DMF holders send a letter of authorization in 2 copies to the FDA and one copy to the applicant, and the reason a letter of authorization is required is that it is the only mechanism that triggers the DMF review process.