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FDA Discusses Upcoming DMF Electronic Filing Requirements

On February 4, 2016, the U.S. Food and Drug Administration (FDA) hosted a webinar regarding upcoming electronic filing requirements for Drug Master Files (DMFs).  FDA will require DMFs, as well as other pharmaceutical applications, to be filed in electronic common technical document (eCTD) format beginning May 5, 2017. Any paper submissions filed on or after this date will be subject to rejection. There will be no waivers or exemptions for submitting DMFs in eCTD.

FDA’s Electronic Submission Gateway

Any DMF submission 10gb or smaller must be submitted using FDA’s Electronic Submission Gateway (ESG).  During the webinar, FDA advised users to set up an ESG account now, as the process can take several weeks.  Each person in an organization that will use the ESG must obtain their own digital certificate.

Electronic submissions must be made in the version of eCTD currently supported by FDA, which is identified in FDA’s Data Standards Catalog.  Users resubmitting an existing paper DMF in eCTD format may keep their existing DMF number. Electronic DMF numbers must be six digits.  If a user’s DMF number contains less than six digits, zeroes should be added to the left.  For example, if the existing number is 1234, the number would be changed to 001234. Users submitting a new DMF must obtain a pre-assigned application number from CDER before making their first electronic submission.

DMFs Filed Before the Compliance Date

DMFs submitted in paper format before May 5, 2017 are not required to be resubmitted in eCTD format.  However, any amendments or updates to the paper DMF will still have to be submitted electronically. DMF holders may choose to convert their paper DMFs to eCTD in order to expedite FDA’s NDA/ANDA review process. If the DMF remains in paper format, FDA NDA/ANDA reviewers will request a paper copy of the DMF for any information needed that is not in electronic format, thus delaying the review. DMF holders that choose to convert their paper DMFs to eCTD format must first convert their DMF to CTD format.

Obtaining an ESG account and navigating FDA’s strict structural requirements for eCTD submissions can be a long and complicated process. Registrar Corp converts DMFs to eCTD and submits DMFs through FDA’s Electronic Submission Gateway at no cost for DMF Agent clients. We also act as the required point of contact for all technical issues associated with electronic DMF submissions. To learn more, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.