Drug master File (DMF) is a submission to the US FDA, AU-TGA, EU, HC that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs. eCWAY-eCTD SOLUTIONS is a Solution to create DMF for electronic submission in regulatory agencies. Regulatory are going mandatory in submission of DMF in eCTD format (eDMF) and has issued dates for submissions.

ASMF (Active Substance Master File Procedure):

The mandatory format for ASMF submissions for human medicines is now eCTD or structured NeeS. The use of eCTD will become mandatory for all for centralized procedure human ASMF submissions from 1 July 2016.

The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application or amendments and supplements to any of these.

Active Substance Master File (ASMF) allow valuable confidential intellectual property or ‘knowhow’ of the manufacturer of the active substance to be protected, while at the same time allowing the Applicant or Marketing Authorization (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance.