A Regulatory Perspective on the Us and European Drug Master File (Dmf) Frameworks

Abstract

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.