Drug Master Files (DMF) - Basic Facts to be known
- There is no legal or regulatory requirement to file a DMF.
- The agency will review information in a DMF only when an IND sponsor, an applicant for an NDA, ANDA, or Export Application, or another DMF holder incorporates material in the DMF by reference.
- There are no “Open” and “Closed” part of a DMF in the US, as there are in Europe. All parts are considered “closed.”
- EDMF is currently named as ASMF (Active Substance Master File)