Australia readies itself for eCTD only

Starting on 1 November, Australia’s TGA will begin a staged transition for all prescription medicine to eCTD format only. The following prescription medicine will be affected:

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

The next stage will not start until the 1st of June 2022 and will include:

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

And the final stage of the transition will start on the 1st of November 2022 and will include:

• All remaining prescription medicine data, including master files

There are no changes to the specification or validation criteria given for the transition.

Requests for exemptions will be considered by the TGA on a case-by-case basis for organizations that are unable to use the eCTD format for certain applications.

Other products falling under NeeS (Biological, OTC medicine, Registered Complementary Medicine, Assessed Listed Medicine, Listed Medicine Ingredient) do not currently have an eCTD timeframe yet.