Submitting eCTD in Advance of a Milestone Application
Many people erroneously believe that your first eCTD submission is restricted to a major milestone application – Investigational New Drug (IND) application, Biologics License Application (BLA) or New Drug Application (NDA). That’s simply not the case. It’s 100% possible to file pre-NDA meeting requests, meeting packages and meeting minutes via eCTD in advance of the original NDA submission.
FDA eCTD Mandate: One Year and Counting
Almost five years ago, I wrote a post outlining the process for converting a paper application into an eCTD application with FDA. As the saying goes, the more things change, the more they stay the same. Here we are in 2016, and, to the surprise of some and the consternation of many, paper applications are still alive and well. However, their days are numbered, with FDA’s eCTD mandate for certain application types set to take effect one year from today.
Rolling eCTD Submissions a Good Fit for Expedited FDA Programs
A rolling submission is done in waves. Sponsors submit completed sections for review, as opposed to waiting for the entire application to be finished. Smaller portions, as opposed to one large submission, are well suited for projects granted accelerated review timelines. We’re seeing that the means to pull off a rolling submission are available and the awarding of expedited pathway designations is motivating sponsors to proceed with a sense of urgency.
Japan and eCTD: What We Know
Japan’s Pharmaceutical and Medical Devices Agency (PMDA), one of the earliest adopters of eCTD, adheres to a number of unique business rules which create a unique implementation of the eCTD specifications. Information available on eCTD best practices is also limited for this region, primarily due to lower levels of submission activity. What do we already know about submitting eCTDs in Japan and what can we expect later this decade as they implement eCTD v4.0?
FDA to Postpone Major Electronic Initiatives
The requirement to submit certain drug applications in electronic format is at least three years off, and the target date for the implementation of the new Module 1 has been extended yet again according to representatives of the U.S. Food & Drug Administration.