Filing of DMF in US, Canada & Europe

  • S P Yamini Kanti M.pharm
  • Neha Jain
  • Amrish Chandra
  • Vikesh Kumar Shukla

Abstract

DMF (Drug master file) is a kind of confidential document which contains complete, factual and correct information about active pharmaceutical ingredient or finished drug dosage form. A DMF can be used by holder who establishes the file or by one or more parties in support of their files or applications. The Drug master file consist of 2 parts:- (a) the applicant’s part – that contains all the information that the license holder needs to review about quality of drug product & (b) the restricted part – which contains all the confidential information about the manufacturing process that can only be presented in front of authorities. The purpose of this article is to present an overview of DMF filing in different countries which are USA, CANADA, and EUROPE. In USA, CANADA the drug master file is known as DMF only but in EUROPE it is known as ASMF (active substance master file).

Keywords: DMF filing, US, EUROPE, CANADA, ASMF, MAA, IND, NDA, ANDA, BLA

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How to Cite
Kanti, S. P. Y., N. Jain, A. Chandra, and V. Shukla. “Filing of DMF in US, Canada & Europe”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 1, Mar. 2019, pp. 6-12, doi:https://doi.org/10.22270/ijdra.v7i1.295.