INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016
Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI)
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.
Keywords:
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)
Cite Article:
"European Drug Master File (EDMF): An Overview", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.7, Issue 11, page no.b155-b161, November-2022, Available :http://www.ijnrd.org/papers/IJNRD2211116.pdf
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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
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