eCTD is currently FDA’s standard submission format for new drug applications (NDAs), investigational new drug applications (INDs), abbreviated new drug applications (ANDAs), and certain biologics license applications (BLAs). FDA states that DMFs are typically submissions to these applications and, as such, are subject to electronic submission required by section 745A(a) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
After the deadline, FDA will require users to submit DMFs in the eCTD version supported by the FDA Data Standards Catalog. Additionally, an April 2017 FDA guidance document establishes technical specifications for aspects such as submission structure, file formats and versions of submission components, and required locations for datasets and study information.
Existing DMFs that are not in eCTD format, including those in paper form, do not require resubmission; however, additional submissions such as annual reports, supplements, and amendments to these DMFs must be submitted through ESG in eCTD. Existing paper DMFs voluntarily converted to eCTD will retain their current DMF number. Companies typically convert their existing paper DMFs to eCTD to expedite the review process of a NDA or ANDA that references the DMF.
