Similarities and differences in filing for Drug Master File in US, Canada and Europe

  • Unnati Suthar K. B. Institute of Pharmaceutical Education and Research
  • Zuki Patel
  • Vinit Movaliya
  • Niranajan Kanaki
  • Shrikalp Deshpande
  • Maitreyi Zaveri K. B. Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India

Abstract

Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the applicable authority in the intended drug market. The document provides the non-supervisory authority with confidential, detailed information about installations, processes, or papers used in the manufacturing, processing, packaging, and storing of one or further mortal drugs. The DMF form allows an establishment to cover its intellectual property from its mate while complying with non-supervisory conditions for exposure of processing details. There is no non-supervisory demand to file a DMF. Drug Master Files (DMF) is a document containing complete information on an Active Pharmaceutical element (API) or finished drug capsule form. Though there are no non-supervisory conditions to file a DMF, the benefit of its use is inviting. A drug Master Files (DMF) is an voluntary non-supervisory submission and is submitted at the discretion of the DMF holder to help their guests. A DMF is NOT a cover for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. An Active Substance Master File (ASMF) is the presently honored term in Europe, formerly known as European drug Master file (eDMF) or a US- Drug Master File( US- DMF) in the United States.

Keywords: DMF, USFDA, ASMF, EDQM, Health Canada, IND, NDA, ANDA

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References

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How to Cite
Suthar, U., Z. Patel, V. Movaliya, N. Kanaki, S. Deshpande, and M. Zaveri. “Similarities and Differences in Filing for Drug Master File in US, Canada and Europe”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 3, Sept. 2023, pp. 33-38, doi:10.22270/ijdra.v11i3.613.