Drug Master Files (DMF) - Basic Facts to be known

Drug Master Files (DMF) - Basic Facts to be known

 

Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted to the appropriate regulatory authority in the intended drug market. DMF containing complete information on an Active Pharmaceutical Ingredient (API) / drug substance, intermediate of drug substance, packaging material, excipient or drug product.

• There is no legal or regulatory requirement to file a DMF.

•  A DMF is never approved or disapproved .

• 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)