Drug Master File Submission- Operon Strategist

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.

A 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.

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• Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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