Friday 10 January 2014

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)

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