Public Consultation - TGA fees and charges proposal 2025-26

Overview

Consultation: Fees and Charges Proposal 2025-26

The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on the TGA’s proposed fees and charges for the 2025-26 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed changes to fees and charges prior to seeking approval from the Government for any changes.

The TGA, within the Department of Health and Aged Care, protects the health and safety of the community by regulating therapeutic goods for safety, efficacy, performance and quality. The TGA recovers its costs mostly from sponsors and manufacturers of therapeutic goods in accordance with Australian Government Charging Framework. The Therapeutic Goods Act 1989 provides the legal authority for the TGA to charge for its regulatory activities. The Therapeutic Goods (Charges) Act 1989 provides the legal authority to levy annual charges on sponsors and manufacturers of medicines, biologicals and medical devices.

Responding to the public consultation

The consultation is open from Friday, 31 January 2025 to Friday, 28 February 2025. Submissions in response to the consultation paper can be made through the link below during this time period. You can right click on the consultation paper below and open a new tab to access the paper while going through the online survey.

Members of peak industry bodies that the TGA held bilateral meetings with (listed in the consultation paper) are encouraged to present their comments through the respective peak body so that the industry body can present consolidated industry feedback to the TGA.

Enquiries

Any questions relating to submissions should be emailed to TGAFeesAndCharges@health.gov.au

Why your views matter

The TGA has a long standing practice of targeted consultation with industry bodies in relation to the proposed changes to fees and charges for the next financial year. The TGA requests the peak bodies to bring any proposals for fees and charges to the attention of their members.

The TGA also publishes a public consultation paper on fees and charges to provide an opportunity for organisations who are not members of industry bodies (that the TGA meet with), other stakeholders and the wider community to comment on the proposed fees and charges.