On April 7, 2017, the FDA announced that it is extending the compliance date for submitting drug master files (DMFs) in electronic common technical document (eCTD) 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:
- New Requirements for Electronic Submissions of DMFs
- DMF Tip Sheet
- eCTD Submission Requirements: What You Need to Know
- FDA Electronic Submissions Gateway
- Getting Started: Creating an ESG Account
- Recorded webinars and courses:
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