Public Consultation - TGA fees and charges proposal 2024-25

Overview

Consultation: Fees and Charges Proposal 2024-25

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 2024-25 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed 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 industry 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 Thursday, 25 January 2024 to Friday, 23 February 2024. Submissions in response to the consultation paper can be made through the online survey 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.

What happens next

Submissions in response to the public consultation will be considered as part of the decision making of fees and charges for 2024-25. The final outcome of the consultation will be published on the TGA website.

Further to the review submission by the TGA, feedback on submissions will be provided through this website. Public submissions are published in accordance with the permissions provided - see the section on Privacy and your personal information in this consultation.