The eSubmission Change Management Board and the Human Harmonisation Maintenance Group (HHMG) have adopted the updated eCTD validation criteria. The eCTD criteria have been updated in line with published EU Module 1 v3.0 following public consultation. The NeeS validation criteria have been updated to align to the updated eCTD validation criteria. The eCTD validation criteria v6.0, the NeeS validation criteria v4.1 and related release notes are available here. If you have any questions regarding further development or require clarification on these documents, please contact: EUM1spec@ema.europa.eu.
