A Drug Master File, or DMF, is a submission to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. There are four types of DMFs:
- Type II – for drug substance, drug substance intermediate, and materials used in their preparation, or drug product,
- Type III – for packaging material,
- Type IV – for excipient, color, flavor, essence, or material used in their preparation, and
- Type V – for FDA-accepted reference information such as shared system REMs, sterile processing facilities, or toxicology information for a drug substance.
Type I DMFs, which contained information on the manufacturing site, facilities, operating procedures, and personnel not specific to any drug substance were discontinued in 2000 but old documents are still on file. DMF information may be referenced in NDAs, ANDAs, INDs, and BLAs, as well as for premarket approvals for devices and application for new animal drugs.
The holder of a DMF may authorize one or more sponsors to incorporate the confidential information in the DMF into their applications without disclosing that information to the sponsor. The DMF format and submission process is the same as the eCTD, but DMFs are not usually reviewed or approved separately. Instead, the technical contents of a DMF are reviewed in conjunction with the review of applications that reference them. It won’t surprise my readers to learn that DMFs are covered by guidance, which was updated as a draft in October 2019. Type V DMFs may also be used for device-led combination products using device constituent parts that contain electronics or software that are intended to be used as a platform for multiple CDER-led combination products, according to new draft guidance issued alongside the main guidance.
Reach out to me if you want to know more or discuss your medical product development challenges.
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