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U.S. FDA Drug Master File Requirements

U.S. FDA CITATION: 21 C.F.R. § 314.420 (2015)FDA DMF Certificate

Drug companies can submit a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) or Health Canada to provide confidential information about facilities, processes, or articles. The DMF holder can then authorize others to use the information within the DMF submission in support of NDA, ANDA, and other submissions to either agency without disclosing the information to anyone other than FDA or Health Canada.  See examples of DMF types filed with FDA here.

FDA requires Type II, Type IV and Type V DMF submissions to be in electronic common technical document (eCTD) format as of May 5, 2018.

Registrar Corp offers guidance on the structure and format of eCTD submissions. Our Regulatory Specialists will:

  • File a new DMF with U.S. FDA or Health Canada in eCTD
  • Update or Amend an existing DMF with U.S. FDA or Health Canada
  • Convert existing DMFs to eCTD
  • Serve as your Agent for U.S. FDA Communications
  • Reactivate inactive DMFs with U.S. FDA or Health Canada and convert them to eCTD

For assistance with eCTD DMF submission requirements, simply complete the form below.