A Drug Master File or (DMF) is a confidential submission to the US FDA that provides detailed information about facilities, processes, or components used in the manufacturing, processing, packaging, and storing of drugs.
The DMF is submitted by a manufacturer, supplier, or developer of an API (active pharmaceutical ingredient), excipient, or packaging material, and it allows them to provide information to the regulatory authority without disclosing the information to their customers or competitors.
A DMF is referenced in a drug application, such as an ANDA or NDA Application, by the applicant who intends to use the information contained in the DMF to support their own application. The regulatory authority can then review the information in the DMF as part of the evaluation of the drug application.
The purpose of a DMF is to provide information to the regulatory authority, without disclosing proprietary information to the public, to support the regulatory review process of a drug product. This allows the regulatory authority to evaluate the quality, safety, and efficacy of the drug product without needing to disclose confidential information to third parties.
DMF submissions are not mandatory and DMF applications are neither approved nor rejected by FDA. DMFs are subject to strict confidentiality requirements and are not publicly available.
DMF holders are required to notify FDA of any changes in the contents of DMF, authorized parties, transfer of ownership etc. An annual report must be submitted every year listing all changes since the previous annual report. Foreign DMF holders are required to appoint a US Agent in their submissions.
Types of Drug Master Files:
- 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
Liberty Management Group Ltd. can help you with DMF original and annual report submissions & US Agent service.
Namrata
Regulatory Consultant
support@libertymanagement.us