What is the Origin of Drug Master File?

The concept of a Drug Master File was established by the FDA to create a standardized, confidential repository for sensitive manufacturing information. This system was designed to facilitate the drug review process by allowing API suppliers to provide technical details directly to the agency without disclosing proprietary data to their customers (the drug product manufacturers). The DMF is not an approval document itself but a reference file. Its implementation reflects the increasing complexity of the pharmaceutical supply chain and the need for stringent quality assurance.

What is the Mechanism of Drug Master File?

The primary function of the DMF is regulatory efficiency and quality assurance. When a drug manufacturer submits an application for a finished drug product, they reference the DMF number for the API. The regulatory authority can then review the confidential chemical, manufacturing, and control (CMC) information within the DMF to verify the API's quality, purity, and stability. This mechanism prevents the need for the API manufacturer to repeatedly disclose sensitive data to multiple customers, thereby accelerating the time to market for generic and novel medications.

Drug Master File

Meaning

A Drug Master File (DMF) is a confidential, detailed document voluntarily submitted to a regulatory authority, such as the U.S. Food and Drug Administration (FDA), containing proprietary information about the manufacturing, processing, packaging, and storing of a drug substance. This file provides crucial technical data on the Active Pharmaceutical Ingredient (API) or drug component, which is used to support a third party’s regulatory submission, like a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The DMF system streamlines the drug approval process while protecting the intellectual property of the API manufacturer. It ensures the quality and consistency of raw materials essential for hormonal therapies and other critical medications.

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