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Again, FDA has updated the Providing Regulatory Submissions in Electronic Format guideline. Now, the requirement to submit DMF Type III (Packaging Material) electronically (in eCTD format only) become effective 60 months after May 5, 2015 (May 5, 2020).

For DMF Type III, applicant must electronically submit any amendments, supplements, and reports, even if the original submission was submitted to FDA prior to implementation of the electronic submission requirements i.e. May 5, 2020.

Timetable for the Initial Implementation of the Electronic Submission Requirement;

Submission Type Final eCTD Guidance Published on eCTD Requirement Begins From Time Taken After Final eCTD Guidance
NDA, ANDA and BLA May 5, 2015 May 5, 2017 24 Months
Commercial IND and DMF other than DMFs Type III May 5, 2018 36 Months
Type III DMFs (Packaging Material) May 5, 2020 60 Months

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