Drug Master File
A Drug Master File (DMF), in Europe and European Drug Master File (EDMF) or new Active Substance Master File (ASMF) called, is a document in which the pharmaceutical manufacturing and quality assurance of drugs to a Food and Drug Administration for the purpose of drug approval documents can be. The rarely used German-language name is active ingredient master documentation .
There is no legal obligation for a drug manufacturer to create a drug master file and submit it to the authorities. Drug Master Files are often then used when the drug manufacturer and the company that produced the drug with the drug will place on the market, many companies are. With the help of a drug master file, the manufacturer can avoid disclosing confidential information about the manufacture of the drug to his business partner in such cases.
Drug Master Files are usually from an open part ( open part , also applicant's part ) and a confidential part ( restricted part ). In the open part, which is also accessible to the person placing the drug on the market, essential details for analysis and quality control are documented that the person placing on the market needs in order to fulfill his obligations as the holder of the drug approval. In the confidential part, the drug manufacturer documents, for example, the exact synthesis routes of the drug or the process development for production, which often contain manufacturer secrets, which are only accessible to the drug authorities. Both parts of the document are created and maintained by the drug manufacturer and checked by the drug authority. The applicant and distributor only refers to the drug master file in his application for approval after the drug manufacturer has given permission in an authorization letter.
Drug master files for medicinal products for human use are usually submitted in the Common Technical Document format.