On April 7, 2017, the FDA announced that it is format by one year to May 5, 2018. The compliance date for submitting NDAs, BLAs, and ANDAs electronically remains unchanged.
The requirement to submit DMFs using the electronic common technical document (eCTD) format is part of FDA’s overall effort to more efficiently review drug applications. eCTD standardizes how industry submits applications, amendments, supplements, and reports. Implementing electronic DMFs will improve the efficiency of the DMF review process making it easier for FDA to review applications supported by DMFs, and meet their associated PDUFA and GDUFA performance goals.
The FDA has a number of resources to help DMF holders understand eCTD format and how to submit using eCTD:
- Guidance Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document (eCTD) Specifications
- Drug Master Files (DMFs) website
- Fact sheets:
- Recorded webinars and courses:
The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM.
Email: CDERSBIA@fda.hhs.gov
Phone: 1-866-405-5367
Phone: (301) 796-6707
Website: http://www.fda.gov/cdersbia
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