Electronic submissions and data review

Information on activities within the electronic submissions space.

Recent updates

• Sponsors advised of transition to eCTD-only
  10 November 2020
• Reminder: Sequences for responses to requests for information
  27 September 2018
• TGA presentation: ARCS webinar, 22 June 2018
  29 June 2018
• eCTD Document Matrix file download updated to version 2.1
  22 June 2018
• Electronic submissions update – Reminder that the transition period for current Australian regional specification ends 30 June 2018
  6 June 2018
• Advance notice – update to an eCTD file download for version 3.1
  5 June 2018
• Automation of validation of eCTD and NeeS sequences
  4 June 2018

Specifications and validation criteria

• Electronic submissions