Quality & Compliance II: Use of Type III Drug Master Files in Product Registrations

Posted 01 December 2009 | By

Drug master files are a mechanism that material or component suppliers can use to share confidential information with health authorities without disclosing that information to the pharmaceutical company. In the US, a "Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs."1 A DMF permits the sponsor to incorporate the information by reference when submitting an application or an amendment or supplement to the application, or to authorize other individuals to rely on the information to support a submission to FDA without having to disclose the information.


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