DMF filing procedure in US, Europe and Canada: A Review

  • Krishnasis Chakraborty Long Island University


DMF widely known as Drug Master File, is a kind of confidential document which covers all comprehensive, accurate and precise information about Active Pharmaceutical Ingredient (API) or Finished Product Dosage Form (FP). The Drug master file consist of two parts, one the applicant’s part which covers all the information that the license holder needs to review about quality of drug product & other one is the restricted part which covers all the confidential information about the manufacturing process that can only be presented in front of health authorities. 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 present study is to brief an overview of DMF filing in different countries which are USA, Europe and Canada. In USA, Canada the drug master file is known as DMF and in EUROPE, known as ASMF (Active Substance Master File).

Keywords: Drug master file (DMF), ASMF, Master file (MF), API, IND, NDA, ANDA, FDA, eCTD, LOA


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How to Cite
Chakraborty, K. “DMF Filing Procedure in US, Europe and Canada: A Review”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 2, June 2020, pp. 7-14, doi:10.22270/ijdra.v8i2.385.