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Abstract

A REVIEW OF DRUG MASTER FILE AND ACTIVE SUBSTANCE MASTER FILE APPROVAL PROCESS AND THEIR COMPARISION

M.S.L. Divya, S.N. Swaroopa, R. Sanjana and Dr. Daka Nagarjuna Reddy*

Abstract

Maintaining a DMF is vitally important in both the medical and pharmaceutical industries. It is not compulsory that a Drug Master File need to be submitted by law (or) Food and Drug Administration directive, and entirely the submissions are at the discretion of the owner. A Drug Master File is primarily used for providing regulatory compliance by proving the quality, safety, efficacy of the Pharmaceutical Product to meet the required standards. Regarding the Active Substance Master File, European Drug Master File procedure is used to support the regulatory requirements of the active drug substance, while simultaneously enabling the applicant (or) Marketing Authorization Holder to wholly function. The present study aims to provide insight into the overall approval process and their comparison on different essential aspects.

Keywords: DMF, Regulatory Compliance, Confidential, MA, ASMF, Letter of Authorization.


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