An Active Substance Master File (ASMF) is the currently recognised term in Europe, formerly known as European Drug Master File (EDMF) or a US-Drug Master file (US-DMF) in the United States. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details.ĭrug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. Typically, a drug master file is filed when two or more firms work in partnership on developing or manufacturing a drug product. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. There is no regulatory requirement to file a DMF. ( May 2009) ( Learn how and when to remove this template message)ĭrug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. Please help to improve this article by introducing more precise citations. This article includes a list of general references, but it lacks sufficient corresponding inline citations.
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