Therapeutic Goods Administration (Australia) to transition all regulatory submissions to eCTD-only, starting in 2021

 

As of 1 November 2021, the Therapeutic Goods Administration (TGA) will initiate a staged transition to electronic Common Technical Document-only (eCTD-only) for all prescription drugs.

As part of this transition, Australia will adopt best practice standards that are currently applied worldwide. The use of eCTD provides benefits to both sponsors and regulators and will improve lifecycle management and navigation capabilities.

The transition date to eCTD will be done in the following stages:

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

If a sponsor is not able to meet the transition deadline(s) applications for waivers will be assessed by the TGA on a case-by-case basis. The majority of stage 1 and stage 2 applications are already submitted in eCTD format. Longer timeframes have been proposed to ensure that the mandate of the eCTD does not hinder the drugs in the development pipeline.

Do you look for a submission management solution or require help publishing your submissions? Contact us now!

Source: https://www.tga.gov.au/sponsors-advised-transition-ectd-only

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