Regulatory Support for Pharmaceuticals

Voluntary submissions to the FDA that provide confidential details about drug manufacturing processes, facilities, and storage of human drug products.

What It Is and Why It’s Needed

Drug Master Files (DMF) are submissions intended to provide confidential and detailed information about the processes, manufacturing, facilities, packaging and storing of human drug products to the Food and Drug Administration (FDA). 

 

DMF submissions are voluntary and enable parties to reference information without needing to disclose the actual DMF data to those involved. The FDA does not approve or reject DMFs; rather, the agency performs a technical review of the DMF contents as part of the evaluation of applications that reference the DMF. 

What We Do

Regulatory Intelligence

We keep you informed about the latest regulatory requirements to ensure compliance.

Submission Support

We assist in preparing, publishing, and submitting Drug Master Files (DMFs).

Appointed Agent

We can act as your appointed agent if your company is located outside the United States

Overview of The Regulation

The FDA has released a draft guidance document that outlines the procedure for preparing and submitting DMFs. There are four types of DMFs, as listed below:

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.

The provisions for DMF fees established under the Generic Drug User Fee Amendments (GDUFA) apply specifically to Type II DMFs for drug substances (active pharmaceutical ingredients (APIs)) used to support Abbreviated New Drug Applications (ANDAs). However, these provisions do not apply to other Type II DMFs that are used to exclusively support New Drug Applications (NDAs) or Investigational New Drugs (INDs). 

The Electronic Common Technical Document (eCTD) standard format is applicable to DMFs. A complete list of eCTD section headings is available in the Comprehensive Table of Contents Headings and Hierarchy. Before submitting the DMF files, it is necessary to request a pre-assigned application number from either the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). Additionally, it is required to set up an Electronic Submission Gateway (ESG) account. 

The DMF in the eCTD format, along with the FDA Form 3938, must be submitted through the ESG to the appropriate centre (CDER or CBER). Submissions that are 10 GB or smaller must be submitted via the ESG, whereas submissions larger than 10 GB may be submitted either physically (e.g., USB drive) or via the ESG. After the initial submission, all subsequent amendments, annual reports, and letters of authorization must be submitted electronically.