UNIT 5 : Drug Master File (DMF): Structure, Types
his unit explains the concept, purpose, and regulatory importance of the Drug Master File (DMF) in global pharmaceutical submissions. It covers DMF types, country-wise DMF systems, and how confidential information is protected during regulatory review.
Definition
A Drug Master File (DMF) is a confidential regulatory document submitted to a regulatory authority that contains detailed information about facilities, processes, or materials used in the manufacturing, processing, packaging, or storage of a drug.
The primary purpose of a DMF is to allow the holder to protect proprietary information while permitting regulatory authorities to review critical data in support of multiple marketing applications. DMFs are not approved or rejected independently but are reviewed only when referenced in an application such as NDA, ANDA, or IND.
Key Points
Used to protect confidential manufacturing information
Can support multiple applicants and products
Reviewed only upon reference by an application
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