New eCTD Requirements for FDA DMFs
As of May 5, 2018, the U.S. Food and Drug Administration (FDA) requires electronic common technical document (eCTD) format for Type II, Type IV, and Type V drug master file (DMF) submissions, including:
- New DMFs
- Annual Reports
- Amendments
- Supplemental Reports
FDA states that it will reject non-eCTD DMF submissions of these types. Registrar Corp can submit documentation in eCTD to FDA on your behalf.
What is a Drug Master File?
Drug companies submit DMFs to FDA to provide confidential information about facilities, processes, or articles. The DMF holder can then authorize others to use the information within the DMF submission in support of NDA, ANDA, and other submissions to either agency without disclosing the information to anyone other than FDA.
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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.
When do FDA eCTD Requirements take Effect?
Type II, Type IV, and Type V DMF submissions to FDA must be in eCTD format as of May 5, 2018. eCTD format will be required for type III DMF submissions beginning May 5, 2020. FDA recommends using eCTD format to file Type III DMF submissions now despite the extension.
Should I Convert My Existing DMF to eCTD?
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 in eCTD. 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 File 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.
