DMF Submissions, eCTD format, USFDA, EDMF, ASMF Submissions

Drug Master File (DMF) is a file that is used to provide confidential and detailed information about facilities, and processes used in the manufacturing, processing, packaging, and storing of one or more human drugs. A DMF is not a substitute for any Drug Application, or Export Application. It is not approved or disapproved. Technical content of a DMF is reviewed only in connection with the review of a Drug Application, or an Export Application. The DMF usually cover the Chemistry, Manufacturing and Controls (CMC) of a component of a drug product, for example, drug substance, excipient, packaging material. DMFs are of five 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• Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 5, 2018, the United States Food and Drug Administration (USFDA) mandated new DMFs as well as documentation for existing DMFs must be submitted using the Electronic Common Technical Document (eCTD). DMF submissions that are not submitted in eCTD format after this date will be rejected.

European Drug Master File (EDMF)

Active Substance Master File (ASMF) procedure, which 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 at the same time allowing the Applicant or Marketing Authorization (MA) holder to take full responsibility for the medicinal product and the quality and 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.

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

• the Restricted Part (RP) - contains the information that the EDMF holder regards as confidential.

Regional DMFs

The DMFs generated for other regions than the USA and Europe are covered under Regional DMFs for the following countries: Canada, Turkey, Brazil, Korea, South Africa, Australia, Syria, Saudi Arabia. Regional guidelines of the respective countries must be followed for generation and submission of the Regional Drug Master Files.