Mary Waters, Consultant
At the DIA Regulatory, Submission and Information Management (RSIDM) conference held in Bethesda, MD, February 2018, the FDA directly stated that they would not delay the implementation of the eCTD DMF mandate again.
If your company/organization has taken a ‘wait and see’ approach to determine how they will comply with this mandate – maybe just hoping for another delay or even possibly a repeal – your time is just about up! If this your organization, you need to make something happen NOW!
Previously, the FDA allowed additional time to transition over from paper to electronic to allow DMF holders to prepare. That said, beginning on May 5, 2018, all new DMFs, as well as all documents submitted to existing DMFs, must be submitted using the electronic Common Technical Document (eCTD).
DMF submissions that are not submitted in eCTD format after this date will be rejected.
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