From 1 November 2021, the Therapeutic Goods Administration (TGA) will begin a staged transition to Electronic Common Technical Document-only (eCTD-only) for all prescription medicines.
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.
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 May 2023 - eCTD-Only Stage 3:
TGA has postponed stage 3 of mandating eCTD ('All remaining prescription medicine data including master files') until 1 May 2023 to allow sponsors more time to transition due to the disruption of COVID-19 over the past two years. It is still highly recommended that data is submitted in the eCTD format for all prescription medicine submissions, and that sponsors continue in their transition to eCTD.
What if a sponsor can't meet this timeline?
The majority of Stage 1 and Stage 2 applications are already provided to us within the eCTD format. Longer timeframes have been proposed to ensure that the mandating of the eCTD does not hinder medicines within the development pipeline.
Requests for exemptions will be considered by the TGA on a case-by-case basis if you are unable to use the eCTD format for an application.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.