Convert or Inactivate DMFs Before the May Deadline for Electronic DMFs
​[Posted on: Thursday, January 19, 2017]

Starting 5 May 2017, FDA will require all DMFs be submitted only in the electronic CTD format creating a huge burden on owners of non-critical DMFs. Converting to eCTD format requires special skills, software and resources, the cost of which could be prohibitive to small manufacturers. To avoid the hassle of converting to eCTD format, owners of DMFs can simply inactivate their paper DMFs before the deadline and use other mechanisms to share the information. Alternately, the cost of converting to the eCTD format can be passed on the clients referring the DMF in question. The main purpose of a DMF is for a manufacturer to submit confidential proprietary information to FDA, and then provide a cross-reference authorization to all its clients. That way, the confidential information does not need to be shared with other parties while still being available to FDA in support of the client’s application. There is no legal requirement to submit a DMF; information contained in a DMF can be directly shared with others under confidentiality agreements, business agreements, additional intellectual property costs, patent disclosures or other mechanisms. DMFs are not approved by FDA and are reviewed only when someone seeks to cross-reference the information in a DMF in support of another application such as an IND or an NDA. So, DMFs that are no longer being used in support of other applications practically have no need to exist. The requirement for electronic submission of DMFs is not retrospective so all information submitted till 4th May 2017, does not need to be resubmitted in the eCTD format. However, all future submission to the DMFs such as letters of authorization, annual updates and other changes must be submitted electronically so all DMF holders need to create eCTD formats of their DMFs anyway. Hence this is the time to make a decision regarding keeping a DMF alive or inactivating it. DMFs that are currently being referred have no option but to be converted to eCTD format. New eDMFs should only be created if they contain proprietary confidential information that cannot be shared with other parties even under confidentiality agreements, etc. All non necessary DMFs should be avoided. If a DMF is necessary for business reasons then the additional cost of the eCTD conversion and maintenance will either be absorbed as the cost of doing business or passed on to clients. Whatever you decide, you have a little more than 3 months to do so as after 5th May 2017, FDA will refuse to accept any paper DMF submissions.