https://matjournals.net/pharmacy/index.php/JPDRA/issue/feedJournal of Pharma and Drug Regulatory Affairs (e-ISSN:2582-3043)2025-09-01T05:00:47+00:00Open Journal Systems<p><strong>JPDRA</strong> provide platform to Researchers, Academicians, Scholars, and Professionals in the Pharmacy domain to promulgate their Research / Review / Case studies in the field of Drugs. The journal with a wide scope in the arena of pharmaceutical sciences covers the topics intended to be of interest to a broad audience of pharmaceutical professionals and ideally placed to serve the needs of their readers. The Scope of this Journal includes ICH/GCP, Regulatory Affairs for Medical Devices & Manufacturing Processes, Import and Export of Drugs, Biopharmaceutical Indian Regulations, Good Manufacturing Processes, Drug Mastery File and Dossier, Drug & Biologics Regulatory Affairs, DMF, Ayurvedic Regulations, Medical Diagnostics.</p>https://matjournals.net/pharmacy/index.php/JPDRA/article/view/227A Regulatory Perspective on the Us and European Drug Master File (Dmf) Frameworks2025-09-01T04:56:21+00:00Sadhu Venkateswara Raovenkateshsadhu@gmail.comShaik Afreen Fathimavenkateshsadhu@gmail.comKalpagiri Sanjanavenkateshsadhu@gmail.comPolicharla Amruthavallivenkateshsadhu@gmail.comNadella Sailajavenkateshsadhu@gmail.comPatakamudi Nikhithavenkateshsadhu@gmail.com<p><em>The Drug Master File (DMF) is an important part in making sure that drugs are safe, effective, and kept secret. This page gives a detailed comparison of the DMF regimes in the US and the EU. The article talks about the rules, submission processes, contents, and functions of each framework in the medication approval process. The Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in the European Union, along with national competent agencies, have set up different but complementary ways to handle DMF. Global manufacturers who want to fulfil compliance standards in all areas must have a good awareness of various regulatory ideas. The final section of the manuscript gives pharmaceutical companies who want to make their regulatory submissions more consistent some useful advice.</em></p>2025-09-01T00:00:00+00:00Copyright (c) 2025 Journal of Pharma and Drug Regulatory Affairs (e-ISSN:2582-3043)