Drug Master File

In this article, we are going to learn about DMF and types of drug master files etc. By the end of this article you are going to the requirement of DMF in regulatory submission i.e. its purpose and also the contents of each drug master file

Always question WHY? if you ask why, then you are in a learning mindset

Generally, a drug master file is a supporting document to an IND, NDA, ANDA and it’s not a substitute.  A drug master file is checked only when it is referenced in any application or other DMF.

So, why we are using Drug Master Files?

A Drug Master File is a submission to regulatory authorities like FDA, it contains confidential and detailed information about Chemistry Manufacturing and controls i.e. CMC information of a drug product or its component.

DMFS types: There are five types of DMFS previously and currently only 4 types are there as of now. Type -1 DMF is withdrawn  as per FR notice Jan 12, 2000, Type -1 DMF elimination done by July 10 ,2000.

TYPE-1 Contains Plant information is withdrawn

Current types of DMF:

Type -2:  Drug substance, drug product and intermediates, materials used in their manufacturing

Type -3: Packaging information

Type -4: Excipients’

Type -5:  It contains information which is not covered by Type-1 to Type -4 drug master files

There is no legal requirement to file a drug master file and it is used to submit the CMC information that the FDA reviews and it’s not a substitute for any applications and is used as a supporting document.