What is Drug Master File (DMF) and types of Drug master file in pharmaceutical

Drug Master File (DMF) is a confidential data provided by the manufacturer to the Food and Drug Administration (FDA) for review, before approving any product to market in the United States of America (USA).
In this article, we are going to learn about the drug master files, How many types of drug master files and what are the types of drug master files.

Drug master file
Drug master file

What is the Drug Master File (DMF)?

Drug Master File (DMF) is  a document provided by the manufacturer submission to the Food and Drug Administration (FDA) may be used to provide confidential information about facility, processing,or articles used in manufacturing processing, packaging, and storing of the one or more human drug.

By the law or FDA regulation submission of the DMF is not required. DMF submission is the full interest of drug holders.

Which guidelines state about Dug Master File?

  The guideline for DMF is 21 CFR 314.420.
In this chapter, it is mentioned about the submission of DMF.
21 CFR             —Code of federal regulation.
Chapter 1        — Food and Drug Administration.
Subchapter D  — Drug for human use.
Part 314          — Application for FDA approval to market a new drug.
Subpart G       — Miscellaneous Provision
Sec 314.420    —Drug Master File.
      First of all in short we will understand what the is FDA and what is the role of the FDA to clear our understanding.


What is the Food and Drug Administration (FDA)?

Food and Drug Administration (FDA) is federal agency of United States of America (USA) department of health and human services. It is one of the executive department of USA.


What is the role of the Food and Drug Administration (US-FDA)?

        FDA is a government body of the USA established in 1906. FDA is responsible for the protection of public health by ensuring the Quality, Safety, and Efficacy of drugs for human and veterinary purposes in the US market.
USFDA gives approval for new products to market the product in the US by confirmation of product quality.

Drug Master File
Drug Master File


How many types of Drug Master Files (DMF)?

According to their functionality, there are a total of five types of Drug Master File in pharmaceutical. 

What are the types of Drug master files?


DMF Type I –

The DMF type I contains information of manufacturing facility, operating procedure, and personnel.

DMF Type II –

The DMF type II contains information about the single drug, single product, drug substance intermediate, and material used in the preparation. 
   Type II DMF includes some of the general points, those are: 
 a. Manufacturing section
 b. Quality control
      i. Input ( Raw material/packing material)
     ii. Intermediate and in process
    iii. Finished drug substance
 c. Validation 
 d. Stability Data
 e. Impurities
 f. Packaging and Labelling

DMF Type III –

The DMF type III contains information on packing material.

DMF Type IV – 

The DMF type IV contains information about helping agents such as excipient, colorant, flavor, and essence.

DMF Type V

In this DMF FDA accepted information. Only when all the above-mentioned DMF is not relevant. Generally, FDA doesn’t accept or strongly discourage the use of type V DMF.
   Type V DMF usually contains clinical data, toxicity data.

These are total of five types of drug master files. 

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What is the advantage of DMF?

DMF is not a regulatory bound document, it’s solely at the discretion of the manufacturer. DMF contains detailed information on the drug. When manufacturers submit DMF it’s intention is that to understand the procedure by reviewing of documents by FDA reviewer to get fast approval of NDA, ANDA of the product.

Why Submission is Needed?

    The main objective of DMF submission is to support regulatory requirements and to prove the Quality, Safety, and Efficacy of the medicinal product for obtaining an NDA, ANDA, another DMF, or as an export application.

Information Of DMF:

In the guideline, some basic information mentioned that needs to follow.
● DMF must be submitted in two copies, one is blue cover and the other in a red cover.
● Each page of each copy of the DMF should be dated and consecutively numbered.
● The paper must have a standard size. The paper length should be Not less than 10 inches and Not more than 12 inches.
●  DMF should be in multiple volumes and each volume should be Not more than 2 inches thick.

Types of Drug Submission in US, Canada & EU: 

The USA– NDA for a new drug, ANDA for Generic and Biologic Licence Application (BLA) for Biologic product.
Canada– New Drug Submission (NDS) for both new drug and biologic products.
EU-Marketing Authority Application (MAA) via the centralized product for digital products. And for other products via the decentralized, mutual recognition or National Authorization is applicable.

Drug master file (DMF)
Drug master file (DMF) 

Video for Drug Master File in short:

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