Drug 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. There is no regulatory requirement to file a DMF. 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. Typically, a drug master file is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details.
Description
Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. 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 contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.
A drug master file comprises two parts: the Applicant's Part (USA: Open Part), which contains all the information that the license-holder needs to assess the quality and submit a license or amendment application; and the Restricted Part (USA: Closed Part), which contains confidential information about the manufacturing procedure only disclosed to the authorities.
DMFs in the United States
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
In United States there are 5 types of Drug Master file:
Type I Manufacturing Site, Facilities, Operating Procedures and Personnel
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information
DMFs in Europe
The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.
DMF LISTS
IMPORTANT NOTE
The current list contains DMFs RECEIVED by March 31, 2012. However the submitted date is listed for each DMF.
The list of DMFs is current as of March 31, 2012, through DMF 25923. Changes to the DMF activity status, DMF type, holder name, and subject made since the last update of January 11, 2012 are included.
The list is available in Microsoft Excel and in ASCII (tab-delimited).
The current lists are posted (1Q2012) as well as the lists from the last quarter (4Q2011) to permit users to compare lists for updates and changes.
TYPES OF DMFs
The types of DMFs are:
Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable) Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product Type III Packaging Material Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation Type V FDA Accepted Reference Information STATUS OF DMFS
“A” = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date. “I” = Inactive “N” = Not an assigned number “P” = DMF Pending Filing Review The status conveys no information about whether DMF has been reviewed for technical content.