Australia TGA’s Staged Transition to eCTD-only for Prescription Medicines from 1 November 2020

This transition will see Australia adopt best practice standards that are currently applied across the world. Providing benefits for both sponsors and regulators, the use of eCTD will enhance lifecycle management and navigation ability, making this an effective solution for the compilation, tracking, and evaluation of dossiers.

Transition timeline:
1 November 2021 – eCTD-Only Stage 1:

  • New Chemical Entity Medicine (Type A)
  • New Biological Entity Medicine (Type A)
  • New Biosimilar Medicine (Type A)
  • New Combination Medicine (Type B)

1 June 2022 – eCTD-Only Stage 2:

  • Extension of Indications Medicine (Type C)
  • Major Variation Medicine (Type F)
  • New Generic Product (Type D)

1 November 2022 – eCTD-Only Stage 3:

  • All remaining prescription medicine data including master files

Once sponsors begin using the eCTD for a product, the company must continue to use it for all future submissions.

If a sponsor is unable to use the eCTD format for an application by the timelines, requests for exemptions will be considered by the TGA on a case-by-case basis.

Please refer to the link  for further information:

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