Every year, the Therapeutic Goods Administration (TGA) undertakes a comprehensive targeted consultation by engaging with peak therapeutic industry bodies in regard to the TGA fees and charges being proposed for the upcoming financial year, including TGA application fees for pharmaceutical products/biologicals, chemicals, and medical devices.
- The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA’s public health responsibilities.
- To recover its costs, the TGA must collect charges and fees.
- A fee is charged for a service, such as a product evaluation.
- By nature, these fees represent a type of ‘industry tax’.
- In essence, TGA charges are a form of tax imposed on the regulated industry, applied annually, based on a 1 July to 30 June financial year in Australia.
- The latest TGA fees and charges schedule covers the period of 1 July 2022 through 30 June 2023.
TGA fees and charges for 1 July 2022 to 30 June 2023
The TGA updated its fees and charges on 1 July 2022.
- A Summary of TGA fees can be found by clicking here.
- Read the detailed TGA industry consultation paper for the 2022-2013 financial year by clicking here (Published January 2022).
2022 TGA application fees and charges (examples)
Annual Charges for Prescription Medicines
Annual charges for prescription medicines (TGA – Fees & Charges, Table 1)
- These charges are in the Therapeutic Goods (Charges) Regulations 2018
- Table 1 (below) was excerpted from the TGA’s 2022 Fee Schedule (TGA Fees & Charges) for illustrative purposes
TGA Charges for Priority Review Pathway for Prescription Medicines
Fees & Charges for Priority review pathway for prescription medicines (TGA Application Fees & Charges – Table 3)
- These applications have both an application fee and an evaluation fee.
- These fees are in Schedule 9, Therapeutic Goods Regulations 1990.
- Table 3 (below) – excerpted from 2022 TGA Schedule (Fees & Charges) as an example
Other relevant 1 July 2022 to 30 June 2023 fees and charges can be found by visiting the TGA’s website (click this link for the 1 July 2022 TGA fee schedule).
Note that the charges and fees published by the TGA each year, after the industry consultation period, is a summary of fees and charges, but is not an exhaustive list.
History of TGA fees and charges (Resources)
- TGA Consultation document regarding changes to fees and charges (2021-2022)
- TGA Consultation document regarding changes to fees and charges (2020-2021)
- TGA Consultation document regarding changes to fees and charges (2019-2020)
- TGA Consultation document regarding proposed changes to fees and charges (2018-2019)
Historical examples of TGA fee changes (2018 example)
On 7 June 2018, the Australian Government approved an increase of 1.9 % to most TGA fees and charges, subject to rounding and a minimum increase of $10 to the low fee items. The 2018-19 fees and charges schedule applied to applications submitted to the TGA on or after 1 July 2018. TGA fee changes approved in 2018 included:
- the introduction of an application fee of $530 for the inclusion of Class I medical devices;
- annual charges for provisionally registered prescription medicines;
- changes to fees and charges that apply to manufacturers of medicines (GMP fees and charges); and
- $100 increase of annual charges for listed medicines to $1,120.
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