From 1 November 2021, the Australian Therapeutic Goods Administration (TGA) begins a staged transition to Electronic Common Technical Document- only for all prescription medicines.
Stage 1 of the transition to eCTD-only has just started for all regulatory submissions in Australia. From this date, the following drug applications must be submitted to the Therapeutic Goods Administration (TGA) using the eCTD:
- New Chemical Entity Medicine (Type A)
- New Biological Entity Medicine (Type A)
- New Biosimilar Medicine (Type A)
- New Combination Medicine (Type B)
Although the majority of the applications of stage 1 are already provided to TGA within eCTD format, requests for exemptions will be assessed by the TGA on a case-by-case basis.
For further information you can contact us at: [email protected]
