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|
Team Masuu has qualified and experienced Regulatory Operations professionals who provide end to end eCTD publishing support and services throughout the life-cycle of product
For more details please reach us at firstname.lastname@example.org.