A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that contains critical information regarding the facilities, techniques, or materials used in the production, packaging, or storage of any human drug. Although filing a DMF is not necessary, the manufacturer may decide to do so. DMFs are often submitted to support an investigational new drug application (IND), a new drug application (NDA), an abbreviated new drug application (ANDA), another DMF, an export application, or a combination of these.
A Drug Master File (DMF) is a document that contains detailed information on an Active Pharmaceutical Ingredient (API) or a final drug dosage form. It is known as the European Drug Master File (EDMF), Active Substance Master File (ASMF), and US-Drug Master File (US-DMF) in Europe and the United States.
A master file is a confidential document that covers detailed information about facilities, processes and articles used in the manufacturing, processing, packaging, and storing of biologic, drug, and device products. Master files may also cover other types of information including toxicology and shared system Risk Evaluation and Mitigation Strategies (REMS).
Master files may be referenced in applications submitted for both drugs, biologics, and medical devices.
There are four different types of master files:
• Type I: Manufacturing site, facilities, and procedures
• Type II: Drug substance, intermediates, and preparation materials
• Type III: Packaging materials
• Type IV: Excipients, colorants, flavors, and essences
• Type V: FDA-accepted reference information
While the Type I master file was phased out in 2000, the other master file types continue to be numbered sequentially. The FDA form 3938, a cover letter, and administrative and technical data are required for DMF submissions. The FDA website offers a number of templates to help with the administrative data that has to be prepared for a DMF filing. Complete administrative and technical information should be included in the initial submission, while information on updates and modifications should be included in later submissions.
A transmittal note, administrative details regarding the submission, and the particular data to be included in the DMF as outlined in this section should all be included with every DMF submission. The DMF needs to be written in English. Anytime material is submitted that is written in a language other than English, a precise, certified translation into English must be included as well. Every page in every copy of the DMF needs to be numbered sequentially and dated. Every submission should have an updated table of contents.