EXPLANATORY STATEMENT
Therapeutic Goods (Charges) Act 1989
Therapeutic Goods (Charges) Amendment (2026 Measures No. 1) Regulations 2026
The instrument increases annual charges for therapeutic goods to support cost recovery.
The Therapeutic Goods (Charges) Act 1989 (the Act) imposes annual charges on the registration, listing and inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (the Register), and on the licensing of manufacturers of therapeutic goods other than medical devices. The Therapeutic Goods Administration (the TGA), which is part of the Department of Health, Disability and Ageing, is responsible for administering the Act.
Subsection 5(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing the amounts of charges. Subsection 5(2) of the Act provides that the regulations may prescribe different charges in relation to different classes of goods or, in the case of annual licensing charges, for different steps in the manufacture of therapeutic goods.
Section 4 of the Act provides that annual charges of prescribed amounts are payable in respect of therapeutic goods on the Register, manufacturing licences, and conformity assessment body determinations that are in force at any time within a financial year. In addition, under subsection 4(1A) of the Act, where one or more therapeutic goods are “grouped” and each of the “grouped” therapeutic goods is covered by a single registration or listing number, a prescribed single annual charge will apply for maintaining all the registered or listed goods covered under the same group.
The purpose of the Therapeutic Goods (Charges) Amendment (2026 Measures No. 1) Regulations 2026 (the Amendment Regulations) is to amend the Therapeutic Goods (Charges) Regulations 2018 (the Charges Regulations) to apply an increase of between 6.1 and 6.3 percent to the annual charges set out in those regulations for the 2026-27 financial year, from 1 July 2026.
The increase is made up of an indexation-based increase as well as additional increases that are necessary to ensure full recovery of the known cost increases to the TGA’s costs-recovered activities in 2026-27. The indexation component of the increase is calculated using a formula applied to TGA fees and charges in most previous years. The formula averages the Australian Bureau of Statistics’ Consumer Price Index (CPI) and Wage Price Index (WPI). For the year to September 2025, the CPI was 3.2% and the WPI was 3.4%, producing an indexation figure of 3.3%.
An additional increase beyond simple indexation rates is also factored into the final percentage increases to the annual charges set out in the Charges Regulations for 2026-27. Each year, the TGA reviews its charges to ensure they are set at appropriate levels and that cost recovery for each therapeutic industry sector is adequate and appropriate. Necessary adjustments are made by considering known cost increases, including annual staff entitlement increases and other cost movements. In 2026-27, the TGA expects the costs of its costs-recovered activities to increase by $11.3 million. To ensure the financial sustainability of the TGA’s costs-recovered activities, it is necessary to fully recover this cost increase for 2026-27. To achieve this, an additional increase of 3.1% for all annual charges is necessary. This is added to the above calculated indexation rate to produce a total percentage increase of 6.4% for all of the TGA’s annual charges for 2026-27.
However, in practice, the increases to the annual charges set out in the Charges Regulations are between 6.1% and 6.3%, depending on the kind of charge. This is because the additional increases to annual charges from 2023-24 and 2024-25 for the TGA’s digital transformation and Unique Device Identification (UDI) programs have been excluded from the base amount used to calculate the 2026-27 indexation-based increase for annual charges. As the increases for the digital transformation and UDI programs varied across medicines, medical devices and biologicals, each class of goods has a slightly different adjusted percentage increase for 2026-27.
The Amendment Regulations complement the Therapeutic Goods Legislation Amendment (Fees) Regulations 2026 which, among other things, increases most fees for therapeutic goods for 2026-27 by 4.8%.
Details of the Amendment Regulations are set out in the Attachment A.
The Amendment Regulations are compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.
The Act specifies no conditions that need to be satisfied before the power to make the Amendment Regulations may be exercised. The Amendment Regulations are a legislative instrument for the purposes of the Legislation Act 2003.
The Amendment Regulations commence on 1 July 2026.
Consultation
The TGA undertook public consultation to obtain stakeholder feedback on increases to charges, with a consultation paper released on the TGA website and submissions sought over a three-week period from 6 February 2026 to 27 February 2026. The TGA received 21 submissions. Stakeholders were presented with two options for the annual updates to charges – Option 1 (a 6.1-6.3% increase) and Option 2 (a 4.3% increase). Three respondents supported Option 1, and 12 respondents supported Option 2. Six respondents did not support either option, with some arguing for increases to charges to be limited to indexation only or not increased at all. After considering submissions, Option 1 was selected because it was considered critical to ensuring full cost recovery of the costs of administering the therapeutic goods regulatory scheme given rising costs, the need to avoid reducing service delivery to industry, and the efficient operation of the TGA’s activities.
Authority: Subsection 5(1) of the Therapeutic Goods (Charges) Act 1989
ATTACHMENT A
Details of the Therapeutic Goods (Charges) Amendment (2026 Measures No. 1) Regulations 2026
Section 1 – Name
This section provides that the title of the Regulations is the Therapeutic Goods (Charges) Amendment (2026 Measures No. 1) Regulations 2026 (the Amendment Regulations).
Section 2 – Commencement
This section provides for the commencement of the Amendment Regulations on 1 July 2026.
Section 3 – Authority
This section provides that the Amendment Regulations are made under the Therapeutic Goods (Charges) Act 1989.
Section 4 – Schedules
This section provides that each instrument that is specified in a Schedule to the instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and that any other item in a Schedule to the instrument has effect according to its terms.
Schedule 1 – Amendments
Therapeutic Goods (Charges) Regulations 2018
The Amendment Regulations apply increases to all annual charges relating to the inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (the Register), and licences to manufacture therapeutic goods, that are prescribed by the Therapeutic Goods (Charges) Regulations 2018 (the Charges Regulations) for the 2026-27 financial year. The applied increase is made up of an indexation-based component as well as an additional increase to ensure full recovery of the known cost increases to the Therapeutic Goods Administration’s (the TGA) costs-recovered activities for the 2026-27 financial year.
The indexation-based proportion of the increase is calculated using a formula applied to TGA fees and charges in most previous years. The formula averages the Australian Bureau of Statistics’ Consumer Price Index (CPI) and Wage Price Index (WPI). For the year to September 2025, the CPI was 3.2% and the WPI was 3.4%, producing an indexation figure of 3.3%. However, the actual applied indexation rate to the TGA’s annual charges will be slightly lower than 3.3 percent. This is because the additional increases to annual charges from 2023-24 and 2024-25 for the TGA’s digital transformation and Unique Device Identification (UDI) programs will be excluded from the base amount used to calculate the 2026-27 indexation-based increase for annual charges. As the increases for the digital transformation and UDI programs varied across medicines, medical devices and biologicals, each class of goods will have a slightly different adjusted indexation rate for 2026-27 of between 3.0 and 3.2%.
As well as the indexation-based component of the proposed increases, an additional 3.1% increase to all charges is proposed. This is necessary to ensure known cost increases to the TGA’s costs-recovered activities—such as application assessments, regulatory compliance and monitoring, and laboratory testing services—are fully recovered, to support the financial sustainability of these activities. The increase in the costs of these activities is mainly driven by rising workforce costs, higher corporate overhead costs and increased laboratory maintenance expenses. The total increase applied to the TGA’s annual charges would therefore be between 6.1 and 6.3% for 2026-27. The percentage increases to annual charges are as follows for charges that relate to:
- medicines and biologicals—6.3%
- medical devices that are Class II and above (other than In-vitro Diagnostic (IVD) medical devices)—6.1%
- other medical devices, non-IVD medical devices, and IVD medical devices—6.2%
- other therapeutic goods, and manufacturing licences—6.3%
Items [1], [3], [4], [6], [8], [9], [11], [12] and [23]-[27]
These items amend the relevant amounts of annual charges prescribed in the Charges Regulations, in relation to the inclusion of medicines and biologicals in the Register, from 1 July 2026. These amounts are increased by 6.3%. This increase is based on the 3.3% indexation rate derived from the above composite indexation formula, adjusted to account for the exclusion of previous additional increases applied to these annual charges to support the TGA’s cost recovery of its UDI and digital transformation programs, as well as an additional 3.1% increase to ensure known cost increases to the TGA’s costs-recovered activities are fully recovered.
Items [13], [14] and [17]
These items amend the relevant amounts of annual charges prescribed in the Charges Regulations, in relation to the inclusion of Class I medical devices and IVD medical devices (other than Class 4 in-house IVD medical devices) in the Register from 1 July 2026. These amounts are increased by 6.2%. This increase is based on the 3.3% indexation rate derived from the above composite indexation formula, adjusted to account for the exclusion of previous additional increases which applied to these annual charges to support the TGA’s cost recovery of its UDI and digital transformation programs, as well as an additional 3.1% increase to ensure known cost increases to the TGA’s costs-recovered activities are fully recovered.
Items [15] and [16]
These items amend the relevant amounts of annual charges prescribed in the Charges Regulations, in relation to the inclusion of Class IIa, IIb and Class III medical devices in the Register from 1 July 2026. These amounts are increased by 6.1%. This increase is based on the 3.3% indexation rate derived from the above composite indexation formula, adjusted to account for the exclusion of previous additional increases applied to these annual charges to support the TGA’s cost recovery of its UDI and digital transformation programs, as well as an additional 3.1% increase to ensure known cost increases to the TGA’s costs-recovered activities are fully recovered.
Items [2], [5], [7], [10], and [18]-[22]
These items amend the relevant amounts of annual charges prescribed in the Charges Regulations, in relation to licences for the manufacture of therapeutic goods or related products, and in relation to other therapeutic goods from 1 July 2026. These amounts are increased by 6.3%. This increase is based on the 3.3% indexation rate derived from the above composite indexation formula, adjusted to account for the exclusion of previous additional increases applied to these annual charges to support the TGA’s cost recovery of its UDI and digital transformation programs, as well as an additional 3.1% increase to ensure known cost increases to the TGA’s costs-recovered activities are fully recovered.
ATTACHMENT B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods (Charges) Amendment (2026 Measures No. 1) Regulations 2026
This disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of legislative instrument
The Therapeutic Goods (Charges) Act 1989 (the Act) imposes annual charges on the registration, listing and inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (the Register), and on the licensing of manufacturers of therapeutic goods other than medical devices. The Therapeutic Goods Administration (the TGA), which is part of the Department of Health, Disability and Ageing, is responsible for administering the Act.
Subsection 5(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing the amounts of charges. Subsection 5(2) of the Act provides that the regulations may prescribe different charges in relation to different classes of goods or, in the case of annual licensing charges, for different steps in the manufacture of therapeutic goods.
Section 4 of the Act provides that annual charges of prescribed amounts are payable in respect of therapeutic goods on the Register, manufacturing licences, and conformity assessment body determinations that are in force at any time within a financial year. In addition, under subsection 4(1A) of the Act, where one or more therapeutic goods are “grouped” and each of the “grouped” therapeutic goods is covered by a single registration or listing number, a prescribed single annual charge will apply for maintaining all the registered or listed goods covered under the same group.
The purpose of the Therapeutic Goods (Charges) Amendment (2026 Measures No. 1) Regulations 2026 (the Amendment Regulations) is to amend the Therapeutic Goods (Charges) Regulations 2018 (the Charges Regulations) to apply an increase of between 6.1 and 6.3 percent to the annual charges set out in those regulations for the 2026-27 financial year, from 1 July 2026.
The increase is made up of an indexation-based increase as well as additional increases that are necessary to ensure full recovery of the known cost increases to the TGA’s costs-recovered activities in 2026-27. The indexation-based proportion of the increase is calculated using a formula applied to TGA fees and charges in most previous years. The formula averages the Australian Bureau of Statistics’ Consumer Price Index (CPI) and Wage Price Index (WPI). For the year to September 2025, the CPI was 3.2% and the WPI was 3.4%, producing an indexation figure of 3.3%.
An additional increase beyond simple indexation rates is also factored into the final percentage increases to the annual charges set out in the Charges Regulations for 2026-27. Each year, the TGA reviews its charges to ensure they are set at appropriate levels and that cost recovery for each therapeutic industry sector is adequate and appropriate. Necessary adjustments are made by considering known cost increases, including annual staff entitlement increases and other cost movements. In 2026-27, the TGA expects the costs of its costs-recovered activities to increase by $11.3 million. To ensure the financial sustainability of the TGA’s costs-recovered activities, it is necessary to fully recover this cost increase for 2026-27. To achieve this, an additional increase of 3.1% for all annual charges is necessary. This is added to the above calculated indexation rate to produce a total percentage increase of 6.4% for all of the TGA’s annual charges for 2026-27.
However, in practice, the increases to the annual charges set out in the Charges Regulations are between 6.1% and 6.3%, depending on the kind of charge. This is because the additional increases to annual charges from 2023-24 and 2024-25 for the TGA’s digital transformation and Unique Device Identification (UDI) programs have been excluded from the base amount used to calculate the 2026-27 indexation-based increase for annual charges. As the increases for the digital transformation and UDI programs varied across medicines, medical devices and biologicals, each class of goods has a slightly different adjusted percentage increase for 2026-27.
The Amendment Regulations complement the Therapeutic Goods Legislation Amendment (Fees) Regulations 2026 which, among other things, increases most fees for therapeutic goods for 2026-27 by 4.8%.
Human rights implications
As the Amendment Regulations do not introduce any changes to the Charges Regulations other than to implement the changes outlined above, they do not engage any of the applicable rights or freedoms.
Conclusion
The Amendment Regulations are compatible with human rights as they do not raise any human rights issues.
Mark Butler, Minister for Health and Ageing