- DMFs must be submitted using the electronic common technical document (eCTD) format, with some exceptions (e.g., Type III DMFs). See draft guidance for industry Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Rev.7).
- Reminder: Failure to submit an annual report could result in the termination of your DMF.
- DMFs exempted from the eCTD format requirement (i.e., Type III DMFs) or for which the DMF holder has received an eCTD waiver can be submitted to CDER via CDER NextGen or ESG. These exempted DMFs should be submitted in an appropriate alternative electronic format (e.g., separate PDF files following the CTD structure).
Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They:
- Allow parties to reference material without disclosing DMF contents to those parties.
- Are not required by statute or regulation.
- Are neither approved nor disapproved. Instead, FDA reviews the technical contents of DMFs in connection with the review of applications that reference them (e.g., NDAs, ANDAs, INDs, BLAs).
See the draft guidance for industry Drug Master Files for detailed information about preparing and submitting DMFs and to learn about FDA’s DMF review process. (When final, this guidance will represent FDA’s current thinking on DMFs.)
The following DMF web pages cover additional information about DMFs and their submission:
- List of DMFs
- Types of DMFs
- Submission Resources
- Related Information
- Frequently Asked Questions (FAQs) (coming soon)
Please contact firstname.lastname@example.org with all DMF-related submission questions. Include the DMF number, if applicable.
Physical Media Submissions (only accepted if submission is over 10 gigabytes):
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Road
Drug Master File Staff
Beltsville, MD 20705-1266
10903 New Hampshire Avenue
Building 71, Room G112
Silver Spring, MD 20993-0002