*Update: In January 2019, FDA extended the eCTD compliance date for Type III DMFs an additional 12 months (May 5, 2020).
On April 25, 2018, the U.S. Food and Drug Administration (FDA) extended the deadline for the mandatory use of electronic common technical document (eCTD) format for type III Drug Master File (DMF) submissions by one year. eCTD format will now be required for type III DMF submissions beginning May 5, 2019.
Type II, type IV, and type V DMF submissions to FDA must be in eCTD format beginning May 5, 2018. Additionally, FDA recommends using eCTD format to file Type III DMF submissions despite the extension. eCTD submissions must be filed through FDA’s Electronic Submissions Gateway (ESG). The process to obtain access to ESG can take several weeks, so it is prudent for businesses to begin working toward compliance as soon as possible.
You can make compliance easy by having Registrar Corp manage your DMF submissions. Our Regulatory Specialists use FDA’s ESG to submit new DMFs to FDA in eCTD format as well as convert existing DMFs to eCTD to make future updates, reports, and amendments easier. If you are not certain if your DMFs qualify for the extension, Registrar Corp can verify your classifications at no cost.
For more information, contact us by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.