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Frequently Asked Questions (FAQs) on DMF Filing

A list of frequently asked questions on DMF filing is mentioned below - 

What is Drug master file used for?

A Drug Master File (DMF) is used to provide confidential detailed information about materials, facilities, processes, specifications, container-closure system and stability used in the manufacturing, processing, packaging, and storing of one or more human drugs.

Where can I find drug master files?

You can follow the below order in FDA official site to find the drug master files - 

Home > Drugs > Development & Approval Process | Drugs > Forms & Submission Requirements > Drug Master Files (DMFs) > List of Drug Master Files (DMFs)

What are the types of Drug master file?

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information

What is EDMF or ASMF?

European Drug Master File (EDMF) also known as Active Substance Master File (ASMF) is to allow valuable confidential intellectual property or 'know-how' of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the Applicant or Marketing Authorization (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance.

What is difference between ANDA and DMF?

An Abbreviated New Drug Application (ANDA) is an application to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, for of a generic drug product approval in USA market. Where the main objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Abbreviated New Drug Application (ANDA) approval.

What is the difference between DMF and dossier?

Drug Master File (DMF) is part of 3.2.S (Drug substance) of the dossier which contains information regarding API only, whereas the dossier is the collection of detailed documents containing information about a particular drug product for submission to a Regulatory body.

What is DMF review?

As per USFDA, 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.

Is filing of DMF is mandatory?

It is not mandatory to file a DMF. But it is helpful to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product.

Is a DMF Holder required to appoint a U.S. Agent?

Although there is no regulation that requires DMF Holders to appoint an Agent, the Agency strongly recommends appointment of a U.S. Agent for companies outside of the U.S.

What is DMF Form 3938?

DMF Form 3938 provide a standardized fillable electronic form for Drug Master File (DMF) submissions and allow for automated pull of DMF information into FDA databases.

Who Should Use DMF Form 3938?

The DMF Holder and/or the U.S. Agent and/or a 3rd Party Contractor.

What is the difference between DMF and ASMF?

Active Substance Master File (ASMF) formerly known as European Drug Master File (EDMF) is adopted by EMA where Drug Master File (DMF) is adopted by USFDA. But the contents of both are almost same. 

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