As per the requirements under the FD&C Act, FDA issued guidance on May 5, 2015 “Guidance on Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” which established a mandatory requirement for eCTD submission for NDA, BLA, IND, ANDA, and DMF. Submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless exempted from the electronic submission requirements.
With the Deadline hardly 25 days away, FDA has given some leeway to DMF holders. As per the latest revision for the guidance released on April 7, 2017 FDA has extended the deadline for DMF submission by a year to May 5, 2018. In response to industry comments and internal review FDA recognizes that there have been challenges with submission of master files in eCTD format, and eCTD uptake data for master files in particular indicated that adhering to the May 5, 2017 date could have led to high rejection rates of master files and thus slower FDA review processes, and, therefore, potential unnecessary delay in the review of some drug applications.
Timetable for the Initial Implementation of the Electronic Submission Requirement
- NDA, ANDA, BLA – 05/05/2017
- Commercial IND, DMF – 05/05/2018
For more information about the revised guidance please visit the link below. Revision 4