This page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA.
There are no fees associated with submitting or updating DMFs.
How to submit the DMF
It is the TGA's preference to submit the DMF in electronic Common Technical Document (eCTD) or Non eCTD electronic Submission (NeeS) format. The electronic submissions web page provides information and describes the requirements on how to submit these files to the TGA. Please visit Submitting data in the eCTD format and Submitting data in the NeeS format for further information.
Once the DMF is submitted in eCTD format, subsequent submissions should be in the eCTD format in order to maintain a lifecycle.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.