Overview

The Drug Master File (DMF) is used to provide confidential and detailed information about facilities and processes used in the manufacturing, processing, packaging, and storing of one (01) or more human drugs. A DMF is not a substitute for any drug application or export application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of a drug application or an export application. DMF filing usually covers the Chemistry, Manufacturing, and Controls (CMC) of a component of a drug product; for example, drug substance, excipient, and packaging material. DMFs are of five (05) types:

• Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

Beginning May 05, 2018, the United States Food and Drug Administration (USFDA) mandated that the new DMFs as well as the documentation for existing DMFs must be submitted using the electronic Common Technical Document (eCTD). DMF submissions that are not submitted in the eCTD format after this date will be rejected.

European Drug Master File (EDMF)

The Active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or 'know-how' of the manufacturer of the active substance (ASM) to be protected while allowing the applicant or the Marketing Authorization Holder (MAH) to take full responsibility for the medicinal product, and the quality & quality control of the active substance. National Competent Authorities/EMA thus have access to the complete information that is necessary for an evaluation of the suitability of the use of the active substance in the medicinal product.

The Active Substance Master File (ASMF), commonly known as the European Drug Master File (EDMF), is a submission made to the European Competent Authorities and/or the EMEA in support of the Marketing Authorization Application [MAA] or Marketing Authorization Variation [MAV] of a medicinal product. The ASMF/EDMF shall be prepared in the Common Technical Document (CTD) format.

The scientific information in the EDMF should be physically divided into:

• The Applicants Part (AP) - Contains the information that the EDMF holder regards as non-confidential to the applicant/MAH
• The Restricted Part (RP) - Contains the information that the EDMF holder regards as confidential

Regional DMFs

The DMFs generated for regions (excluding the USA and Europe) are covered under regional DMFs for the following countries: Canada, Turkey, Brazil, Korea, South Africa, Australia, Syria, and Saudi Arabia. Regional guidelines of the respective countries must be followed for DMF filing and submission.