Programme and Process of Regulatory Aspects of Drug Master Files and European Drug Master Files

Abstract

The complexities of the paper documentation required by the FDA to fulfill the needs for even relatively simple submissions mandate the establishment of Drug Master Files with the Bureau of Drugs when feasible to minimize the repetitive submission of routine information. A Drug Master File established with the Bureau of Drugs is a confidential document serving as a reference source for detailed information on a plant facility, plant personnel, chemical process, packaging item or process, manufacture of a raw material and final drug dosage form, equipment, operating procedures, color additives or colorants, clinical studies or animal safety studies, and similar items or processes. The Drug Master File may be utilized either by the “holder” who establishes the file, or by one or more additional parties in support of their application when so authorized by the holder. Typically, a DMF is filed when two or more firms work in partnership on developing or manufacturing a drug product. 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. Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished Drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master File (US-DMF) in Europe and United States respectively.