Comparative Review of Drug Master File (DMF) Filing Procedures in the United States, European Union, and India

The Drug Master File (DMF) plays a vital role in global pharmaceutical regulation by enabling the submission of confidential manufacturing and quality information to regulatory authorities while safeguarding proprietary knowledge. Despite its shared purpose, the structure, review process, and regulatory expectations for DMFs differ significantly across major pharmaceutical markets. This project aims to systematically compare the DMF filing procedures followed in the United States, the European Union, and India, with a focus on regulatory frameworks, submission formats, review mechanisms, lifecycle management, and transparency requirements.A qualitative, descriptive, and comparative methodology was employed, based on a detailed review of official regulatory guidelines issued by the U.S. Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and the Central Drugs Standard Control Organization (CDSCO), supported by peer-reviewed literature and regulatory publications. Key similarities and differences among the U.S. DMF system, the European Active Substance Master File (ASMF) and Certificate of Suitability (CEP) pathways, and India’s evolving DMF framework were analyzed.The findings highlight substantial divergence in procedural philosophy, particularly with respect to review timing, applicant–holder communication, and regulatory transparency. The study underscores the need for jurisdiction-specific regulatory strategies and emphasizes opportunities for improved harmonization to reduce development timelines and regulatory burden. Overall, this review provides practical insights for regulatory professionals, API manufacturers, and pharmaceutical companies engaged in global drug development and registration.