U.S. FDA eCTD Requirements for Drug Master Files (DMFs) 

24/7 Live Assistance with U.S. FDA Regulations: www.registrarcorp.com/livehelp
Beginning May 5, 2018, the U.S. Food and Drug Administration (FDA) will require DMFs and DMF submissions (amendments, annual reports, etc.) to be filed in electronic common technical document (eCTD) format. Any paper submissions filed on or after this date will be subject to rejection. There will be no waivers or exemptions for submitting DMFs in eCTD.