The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
The New Active Substance Work-Sharing Initiative (NASWSI) is an innovative work sharing procedure for the coordinated assessment of new chemical entity or new biological entity applications, or new indication applications that are submitted to two or more Access agencies.
By participating in this initiative, Access agencies are able to co-ordinate regulatory review procedures, and increase each agency’s capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.
For more information about work-sharing and its benefits for sponsors, see Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium.
New Active Substances approved through work-sharing
The TGA has approved the following medicines through the New Active Substance Work-Sharing Initiative (as of 9 January 2025):