European Drug Master File (EDMF): An Overview

European Drug Master File (EDMF): An Overview

Registration ID: IJNRD_183987

Published ID: IJNRD2211116

DOI: Click Here to Get

Atish S. Mundada , Shruti Shinde

European Drug Master File (EDMF), European Medicine Agency (EMA), Health Authorities (HAs), Active Pharmaceutical Ingredients (APIs), European Economic Area (EEA), Marketing Authorisation Application (MAA), Marketing Authorisation Variation (MAV)

The submission of a drug master file (DMF) by the active ingredients manufacturer (AIM) is one of the methods of providing confidential data on a drug substance to licensing authorities. A European Drug Master File (EDMF) is a reference source that provides drug evaluators with confidential information about the active ingredients. The European drug master file (EDMF) allows AIM to provide the description of three types of active ingredients: new active ingredients, off-patent active ingredients, and pharmacopoeial ingredients. EDMF contains sensitive information and hence it is split into two sections: an applicant section and a restricted section. The submission of the initial EDMF and any subsequent updates, is always done as a part of a new marketing authorisation application (MAA) or marketing authorisation variation (MAV).The present review article will give detail insight into the EDMF, its contents and submission process.

Published Paper   E-Certificate

"European Drug Master File (EDMF): An Overview", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.7, Issue 11, page no.b155-b161, November-2022, Available :https://ijnrd.org/papers/IJNRD2211116.pdf

Volume 7 Issue 11, November-2022

Pages : b155-b161

Paper Reg. ID: IJNRD_183987

Published Paper Id: IJNRD2211116

Downloads: 000121217

Research Area: Pharmacy

Country: Nashik, Maharashtra, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2211116.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2211116

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJNRD (IJ Publication) Janvi Wave

This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition

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