GLOBAL eCTD IMPLEMENTATION TRACKER Track eCTD versions, pilots, voluntary acceptance, mandatory dates and regulatory changes worldwide.
Regions tracked20
Specs33
Links103
Updated2026-11-07
V4.0

Markets where eCTD v4.0 is Piloting

Markets grouped by their current eCTD v4.0 implementation stage. Dates carry source-confidence badges; expand a row for the full timeline.

Markets where eCTD v4.0 is Piloting


AUAustraliaTGA · Therapeutic Goods AdministrationPilotingNo official dateStarted H2 2025
Technical pilot
Started H2 2025 (ongoing · per TGA)
Voluntary
2029 (per ICH table)
Mandatory
TBD
Mandatory scope
TBD
Open

In force · Voluntary · eCTD v4.0