What is proposed
Australia’s Therapeutic Goods Administration opened a public consultation on its proposed 2027–28 fees and charges on 19 October 2026. Comments are due by 16 November 2026.
The TGA is seeking feedback on the potential effects of its proposed charges before requesting Government approval for changes. The consultation notice does not establish an approved fee increase.
The regulator recovers most of its costs from therapeutic-goods sponsors and manufacturers. Its fee and annual-charge framework covers medicines, biologicals and medical devices, making the consultation relevant to device and IVD businesses planning their Australian regulatory budgets.
Who can respond and when
Sponsors, manufacturers and other interested stakeholders can respond through the online survey before the consultation closes on 16 November 2026. Members of peak industry bodies that participated in bilateral meetings with the TGA are encouraged to channel comments through those bodies so they can provide consolidated feedback.
For device businesses, a useful response would identify which proposed charges affect their activities and explain the operational or budget impact. That assessment should use the consultation paper rather than assume a uniform percentage increase.
Sources
- Primary official sourcePublic Consultation - TGA fees and charges proposal 2027-28 (opens in a new tab)Therapeutic Goods Administration