Links to selected regulatory authorities and related bodies are shown below. This section will be expanded soon, as we are currently completing a survey of eCTD-related information on websites from the individual EU member states.

ICH - ESTRI index page

US FDA - eCTD index page

US FDA - SPL index page

EMEA eSubmission index page

EU CMDh Best Practice Guide on the use of eCTD in the MRP/DCP

EU Heads of Agencies (includes links to many individual European authorities)

Australia

Canada