Electronic Submission of Drug Master Files (DMFs)
Submitting Drug Master Files (DMFs) electronically is new territory for many DMF holders. On top of the technological learning curve, mandates from the US FDA and Health Canada have created accelerated “must meet” timelines for new DMF submissions, amendments to previously submitted DMFs and resubmissions (Health Canada).
Agile DMF Submissions
Synchrogenix’s Regulatory Services team is able to offer quick turnaround times, easy onboarding, and expert consulting and project management services for electronic (eCTD and non-eCTD electronic or NeeS) DMF submissions to both the US FDA and Health Canada.
Synchrogenix’s Regulatory Services Team applies Agile Product Management methodology to regulatory submissions and has successfully submitted 75% of projects ahead of schedule.
Synchrogenix understands that one of the main drivers of Drug Master Files (DMFs) is confidentiality. We have documented security procedures in place to ensure that your proprietary information is protected during the transmission, production and storage (archival) phases of a project.
Resubmission of Drug Master Files (DMFs)
Regulations governing resubmission of DMFs differ for the US FDA and Health Canada. The following statements are pulled directly from Agency websites or guidance documents.
“Currently, there is not a requirement to submit or resubmit DMFs in an electronic format. However, beginning on May 5, 2017, new DMFs as well as amendments to previously submitted DMFs (i.e., amendments) must be submitted in electronic format, as specified by FDA in the eCTD guidance.”
“As of March 31, 2016, all existing DMFs in paper format must be replaced by a complete DMF conversion in “non-eCTD electronic only” format. Failure to provide the complete electronic copy of the DMF will result in the DMF being suspended (no further access for review will be granted and no updated will be accepted for the DMF).”
Guidance and Resources for Drug Master Files (DMFs)
- New Requirement for Electronic Submission of DMFs
- Official Agency Website – Drug Master Files (DMFs)
- Guideline for Drug Master Files
- Guidance for Industry: Provide Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications