Companies who are using eCTD for submissions or developing eCTD tools should take note that the ICH M8 group completed an update to the ICH eCTD v4.0 Implementation Package during the ICH June 2018 meeting. The updated implementation package (v1.3) should be posted on the ICH eCTD v4.0 webpage in August 2018.
Concurrently within the CBER-CDER Data Standards program, the FDA is finalizing the initial draft eCTD v4.0 Technical Conformance Guide to harmonize with the ICH standard. The FDA currently uses eCTD v3.2.2. and has prepared a Module 1 Implementation package for planning purposes.
That package may be downloaded here. Core information about the current eCTD program may be found here.
Text Copyright © 2018 Katrina Rogers