Abstract

A REVIEW ON PREPARATION OF DRUG MASTER FILE FOR REGULATORY APPROVALS

Balusupati Lakshmi Kanth*, Vaka Naga Durga Bhavani, M. V. Nagabhushanam, Santosh Kumar Ch, Brahmaiah Bonthagarala, G. Ramakrishna and Y. Ratna Sindhu

ABSTRACT

A drug master file (DMF) is a confidential, detailed document submitted by Active Pharmaceutical Ingredient (API) manufacturers to the U.S. Food and Drug Administration (FDA). A DMF contains the chemistry, manufacturing, and controls of a drug component. A drug master file is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details. The DMF contains factual and complete information on a drug product’s chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product. The pharmaceutical industry is one of the most regulated industries; no drug would be marketed without the teams of medical researchers and other specialists who worked to make sure it receives regulatory authority’s approval. There is no legal or regulatory requirement to file a DMF. This study gives the information on regulatory requirements of Drug Master Files by Food and Drug Administration (USA), European Medicines Agency (Europe), Ministry of Health Labor and Welfare (Japan), Central Drug and Standard Control Organization (India) and WHO and their comparison.

Keywords: DMF, intellectual property, regulatory authority, FDA, WHO.