Drug Master File (DMF) Submission Guideline

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The Drug Master File is a document that is prepared by the medical device maker/manufacturer, in which he/she provides confidential information about the product to USFDA. This document is a submission to the Food and Drug Administration (FDA) that provides the regulatory authority with confidential, detailed information about facilities, processes or articles used in the manufacturing, packaging, processing, and storing of one or more human drugs.

Drug Master File (DMF) is neither approved nor rejected; it is reviewed by FDA when referenced by an applicant in a regulatory submission.

DMF Preparation and DMF Submission:

The Main Objective of the Drug Master File (DMF) is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal products. Beginning on May 5, 2018, new Drug Master Files, as well as all documents submitted to existing Drug Master Files, must be submitted using the Electronic Common Technical Document (eCTD). The Drug Master File (DMF) submissions that are not submitted in eCTD format after this date will be rejected. In the United States, there are 5 types of Drug Master File.

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Drug Master Files classified are as follows:

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 (Note: There appears to be some confusion regarding when a Type III Drug Master File (packaging material) should be submitted. It is not required that packaging information is submitted to the FDA in a Drug Master File.

 

This information may be provided to the applicant by the manufacturer of a packaging component or material of construction and may be included directly in the application.

Any information that a manufacturer does not wish to share with the applicant or sponsor may be placed in a Type III Drug Master File and incorporated into the application by a letter from the manufacturer to the applicant which authorizes reference to the Drug Master File.)

  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation.
  • Type V FDA Accepted Reference Information.
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The manufacturer shall maintain the quality management system to make sure that the product meets the requirement. ISO 15378 can be implemented to demonstrate the compliance. Depending on the nature and usage of the primary packing material, the extent of the implementation shall be decided.  The Drug Master File shall include information about the manufacturing unit and the information about the quality management system. The FDA may review the file in the context of the submitted product and the suitability of its usage for the product.

Operon Strategist helps and assists you in the preparation and submission of all types of Drug Master Files (DMFs). The data compilation and submission happens at the operon site and the raw data shall be provided by the client as per expected and guided formats.