Drug master file of United States and europirean countries

Abstract

A Drug Master File is a confidential document used to provide detailed information about facilities, processes or

articles used in the manufacturing process, packaging and storing of one or more human drug. The Drug Master File

may be utilized either by the holder who establishes the file, or by one or more additional parties in support of their

application.The Drug Master File filing allows a firm to protect its intellectual property from its partner while

complying with regulatory requirements for disclosure of processing details. The review includes various types of

Drug Master Files, the important aspects in filing and processing. In this presentation we did individually study about

the rule & regulations which are followed for drug approval process in USA, Europe. This comparative study of

dossier compilation given a brief idea about the difference in regulatory requirements for drug approval process

among USA, EU. In this presentation we have also discussed about dossier. Process of reviewing and assessing the

dossier of a pharmaceutical product containing its detailed data (administrative, chemistry, pre-clinical and

clinical) and the permission granted by the Regulatory Agencies of a country with a view to support its marketing /

approval in a country i.e., Product licensincing. We have provided few case studies of the Drug Master file for few

drug products and binders and excipients collected from different companies.