In the industry there is lot of confusion about content and format of DMF annual report.
Important – DMF annual reports are NOT used for reporting changes in the drug master file. Amendments are used for reporting changes in the DMF.
1.Cover letter – Annual report should contain the formal cover letter stating the submission contains annual report , referring the DMF number.
2.Tabular summary of amendments since last annual report.- We recommend providing tabular summary with date of amendments and brief information about the purpose of amendments. However, if there are no amendments submitted since last annual report, a statement “no amendments are submitted since last annual report” can be added in the annual report.
3.List of parties to whom LOA (Letter of Authorization ) is issued till date. Incase of authorization are not issued to any companies such statement should be added. In the each DMF annual report complete list if all the authorized parties must be added.
4. List of parties whose authorization letter is withdrawn (if applicable)
When the DMF annual report should be submitted ?
Generally, annual reports should be submitted on the anniversary (after one year ) of original DMF filing.
Failure to submit annual report in timely manner may result in the DMF deactivation, since annual reporting filing is mandatory requirement to maintain “Active” status of your DMF.
FDAbasics can offers services for annual report compilation and submission in the eCTD format including submission to FDA through our ESG gateway.
If you have any questions regarding DMF filing , please contact us.