DMF (Drug Master File) is a confidential & detailed submission to FDA.
There are several steps involved in filing a DMF with the US FDA:
1. Determine the Type of DMF
Identify the type of DMF you need to file (Type II, III, IV, or V).
2. Prepare the DMF Document
- Cover Letter: Include a cover letter containing the type of DMF, the specific content included, and contact information.
- Administrative Information: Provide the DMF holder’s and US Agent’s contact details.
- Technical Content: This varies depending on the type of DMF. It includes manufacturing processes, specifications, testing methods, stability data, and other technical details.
- References and Appendices: Include all relevant references, supporting documents, and appendices.
3. Format of Document
The DMF must be prepared according to the FDA guidelines on electronic submissions using the eCTD format.
4. Compile the Submission
- Ensure all sections are complete and properly formatted.
- Compile the document into eCTD format.
5. Obtain a Pre-Assigned Number
Request a pre-assigned application number for DMF from the FDA.
6. Submit the DMF
Submit the DMF electronically via the FDA’s ESG portal.
7. Pay the Fee
Type II DMF Submission from an API Manufacturer for a generic drug application need to pay FDA fees. There is no FDA fee for other types of DMF submissions.
8. Acknowledge Receipt
Once submitted, FDA will acknowledge receipt of the DMF.
9. Annual Updates and DMF amendments
- Submit annual updates and amendments as needed.
- Keep the FDA informed of any changes to the DMF’s content or contact information.
Liberty Management Group Ltd. can help you DMF submissions & US Agent service.
Namrata
Regulatory Consultant