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July 2026The Therapeutic Goods Administration (TGA) has updated its Annual Charge Waiver Guidelines with minor editorial changes as of 03 June 2026.
Under the Annual Charges Exemption (ACE) scheme, eligible therapeutic goods may be exempt from annual charges until they generate turnover. This applies to certain registered medicines, biologicals, medical devices, and in vitro diagnostic devices.
Sponsors must demonstrate both financial viability and a clear public health need for the product to remain on the Australian Register of Therapeutic Goods (ARTG). Applications should include evidence on patient population, clinical need, available alternatives, and potential health risks if access is limited.
Waivers are granted only for a specific financial year and must be submitted before the deadline. Applications must be signed by a qualified professional and include complete, accurate information.
The TGA reviews completed applications within 60 days. If refused, sponsors may request a review within 90 days. False or insufficient information may lead to refusal, suspension, or cancellation.
Region: Australia
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