TGA Fees and Charges Proposal 2024-25
The Therapeutic Goods Administration (TGA) is seeking feedback on its proposed fees and charges for the 2024-25 financial year. This consultation allows stakeholders to comment on the potential impact of these changes before they are submitted for government approval.
The TGA, responsible for regulating therapeutic goods, operates under a full cost recovery basis as per Australian Government arrangements. This includes application, evaluation, conformity assessment, and inspection fees. The fees and charges cover sectors such as prescription medicines, over-the-counter medicines, complementary medicines, medical devices, blood components, and biologicals.
For 2024-25, the TGA proposes an indexation increase of 4.7% in fees and charges to cover rising costs, particularly in salaries and corporate expenses. This increase also includes cost recovery for the TGA’s Digital Transformation and the Unique Device Identification (UDI) system.
Additionally, changes are proposed for certain fees, such as application audit assessment fees for Class 3 and 4 In Vitro Diagnostic devices (IVDs) and clinical trial notification fees for unapproved medical devices. The TGA also proposes reducing the higher annual charge for specific prescription medicines due to well-established risk management programs.
Stakeholder consultations held in late 2023 revealed general support for the annual indexation increase but concerns about the cumulative effect of additional charges, especially on smaller sponsors.
The TGA encourages broad stakeholder feedback, which will inform the final proposal to the Government. The regulatory impact of these changes is considered to be within agreed parameters, and no further impact analysis is deemed necessary.
Once considering feedback and subject to Ministerial approval, the revised fees and charges will be published on the TGA website and take effect from 1 July 2024. If you would like to provide feedback, this can be done on the TGA website before 23/02/2024.
Guidance on the vigilance system for CE-marked devices and the Device Specific Vigilance Guidance (DSVG) Template
February 19, 2024
Highlights from the 24th Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) in Berlin, Germany
October 18, 2023