Drug Establishments Must Use eCTD Format for U.S. FDA Drug Master File (DMF) Submissions Beginning May 5, 2018
*Update: In January 2019, FDA extended the eCTD compliance date for Type III DMFs to May 5, 2020.
Beginning May 5, 2018, the U.S. Food and Drug Administration (FDA) will require electronic common technical document (eCTD) format for all new Drug Master File (DMF) submissions, including reports and amendments. FDA states that it will reject DMF submissions not in eCTD format following this deadline.
What is eCTD?
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.
How Do I Send an eCTD Submission?
eCTD submissions 10GB or smaller must be sent through FDA’s Electronic Submissions Gateway (ESG). Prior to accessing ESG, a user must request an application number from FDA, register for an ESG account, and configure their computer to communicate with the gateway. FDA advises users to perform a series of tests prior to submission. The process for ESG access may require several weeks.
Alternatively, you can make the process quick and easy by having a Regulatory Specialist, such as Registrar Corp, convert your DMF submissions to eCTD format and submit them to FDA through ESG. 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.