NEW ADVANCEMENTS IN DRUG MASTER FILES GUIDELINES

ABSTRACT 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. There are five types of DMFs, the most common being a Type II DMF followed by a Type III DMF. It should be noted, however, that only four DMFs (types II-V) are still actively submitted as the Type I DMF has been phased out. The Drug Master File filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details. In this review I discussed the regulatory requirements for DMF submission and Mechanism of a Drug Master File. KEYWORDS: Drug Master File, BLA, CMC, eCTD