EXPLANATORY STATEMENT
Therapeutic Goods (Charges) Act 1989
Therapeutic Goods (Charges) Amendment (2025 Measures No. 1) Regulations 2025
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. Paragraph 5(2)(c) also permits the regulations to prescribe different charges for different kinds of conformity assessment body determinations. These determinations specify that an Australian corporation is an Australian conformity assessment body responsible for monitoring the compliance of Australian and overseas manufacturers of medical devices with conformity assessment procedures set out in Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002.
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 (2025 Measures No. 1) Regulations 2025 (the Amendment Regulations) is to amend the Therapeutic Goods (Charges) Regulations 2018 (the Charges Regulations) to increase the annual charges set out in those regulations for the 2025-26 financial year by 3.06 per cent for medicines and biologicals, 2.96 per cent for Class IIa, IIb and III medical devices other than in vitro diagnostic (IVD) medical devices, 3.02 per cent for IVD medical devices and Class I devices and 3.09 per cent for any other therapeutic goods and for manufacturing licences.
The increases are principally based on an indexation formula used to calculate adjustments to TGA fees and charges in most previous years, comprised of the Australian Bureau of Statistics’ Consumer Price Index (50 per cent) and Wage Price Index (50 per cent) (in this case, for the year to September 2024). However, as additional indexation increases were applied in 2023-24 and 2024-25 to annual charges to reflect recovery of costs associated with TGA’s unique device identification and digital transformation work, minor modifications have been made to reduce the indexation for the 2025-26 financial year to prevent a compounded impact on the indexation of these annual charges. These increases are in line with the TGA’s cost recovery model.
The Amendment Regulations complement the Therapeutic Goods Legislation Amendment (Fees) Regulations 2025 which, among other things, increases most fees for therapeutic goods for 2025-26 by 3.2 per cent indexation rate.
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 2025.
Consultation
In relation to consultation, the TGA held bilateral meetings with 13 key industry representative bodies in November 2024 on proposed changes to TGA fees and charges for 2025-26. The industry bodies included Medicines Australia, the Generic and Biosimilar Medicines Association, AusBiotech, the Medical Technology Association of Australia, Consumer Healthcare Products Australia and Complementary Medicines Australia. Most bodies indicated their support for the proposed increase.
The TGA also undertook public consultation to obtain broader stakeholder feedback, with a consultation paper released on the TGA website and submissions sought over a four-week period from 31 January 2025 to 28 February 2025. The TGA received 13 submissions – 9 from industry representative bodies, 2 from sponsors and manufacturers of therapeutic goods, and 1 from a regulatory affairs consultant and 1 from a consumer. Eleven respondents did not raise concerns, with 2 not supporting the indexation increase. After considering submissions, the indexation increase is proposed because it is consistent with the Australian Government Cost Recovery Guidelines and critical to achieving full cost recovery of administering the 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 (2025 Measures No. 1) Regulations 2025
Section 1 – Name
This section provides for the Regulations to be referred to as the Therapeutic Goods (Charges) Amendment (2025 Measures No. 1) Regulations 2025 (the Amendment Regulations).
Section 2 – Commencement
This section provides for the commencement of the Amendment Regulations on 1 July 2025.
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 increase all annual charges relating to the inclusion of therapeutic goods in the Register, and licences to manufacture therapeutic goods, that are prescribed by the Therapeutic Goods (Charges) Regulations 2018 (the Charges Regulations) for the 2025-26 financial year. The total rate of increase that is applied to each annual charge depends on the kind of therapeutic good or licence to which the charge relates. This is because the overall increase to annual charges for the 2025-26 financial year consists of multiple components, not all of which apply uniformly to all annual charges.
The total effective rate of increase that is applied to each annual charge depends on whether that particular charge was previously subject to additional increases to support the TGA’s cost recovery of its unique device identification (UDI) and digital transformation programs. This is because increases which were applied in the 2023-24 and 2024-25 updates to the Charges Regulations, are excluded from the indexation calculations for 2025-26. Therefore, those charges which were previously subject to additional increases are increased at a slightly lower effective indexation rate.
The indexation increases are based on a composite indexation formula that has been used to calculate adjustments to TGA fees and charges in previous years. The formula combines the Australian Bureau of Statistics’ Wages Price Index (WPI) (50 per cent) (in this case, for the year to September 2024) and Consumer Price Index (CPI) (50 per cent) (also for the same period).
In applying the indexation factor to annual charges, additional increases included in 2023-24 and 2024-25 for cost recovery of the TGA’s UDI and digital transformation program have been excluded from the base amount. Therefore, the percentage increase to annual charges are as follows for charges that relate to:
- medicines and biologicals, 3.06%
- medical devices that are Class II and above (other than In-vitro Diagnostic (IVD) medical devices), 2.96%
- other, non IVD medical devices, and IVD medical devices, 3.02%
- other therapeutic goods, and manufacturing licences, 3.09%
Items [1]-[12] and [24]-[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 Australian Register of Therapeutic Goods (the Register), from 1 July 2025. These amounts are subject to an effective indexation rate of 3.06 percent. This effective indexation rate is based on the 3.2 percent 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.
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 (of a class other than a Class 4 in-house IVD medical device) in the Register, from 1 July 2025. These amounts are subject to an effective indexation rate of 3.02 percent. This effective indexation rate is based on the 3.2 percent 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.
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 2025. These amounts are subject to an effective indexation rate of 2.96 percent. This effective indexation rate is based on the 3.2 percent 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.
Items [18]-[23]
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, from 1 July 2025. These amounts are subject to an effective indexation rate of 3.09 percent. This effective indexation rate is based on the 3.2 percent 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.
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 (2025 Measures No. 1) Regulations 2025
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. Paragraph 5(2)(c) also permits the regulations to prescribe different charges for different kinds of conformity assessment body determinations. These determinations specify that an Australian corporation is an Australian conformity assessment body responsible for monitoring the compliance of Australian and overseas manufacturers of medical devices with conformity assessment procedures set out in Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002.
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 (2025 Measures No. 1) Regulations 2025 (the Amendment Regulations) is to amend the Therapeutic Goods (Charges) Regulations 2018 (the Charges Regulations) to increase the annual charges set out in those regulations for the 2025-26 financial year by 3.06 per cent for medicines and biologicals, 2.96 per cent for Class IIa, IIb and III medical devices other than in vitro diagnostic (IVD) medical devices, 3.02 per cent for IVD medical devices and Class I devices and 3.09 per cent for any other therapeutic goods and for manufacturing licences.
The increases are principally based on an indexation formula used to calculate adjustments to TGA fees and charges in most previous years. The formula is comprised of the Australian Bureau of Statistics’ Consumer Price Index (50 per cent) and Wage Price Index (50 per cent) (in this case, for the year to September 2024). However, as additional indexation increases were applied in 2023-24 and 2024-25 to annual charges to reflect recovery of costs associated with TGA’s unique device identification and digital transformation work, minor modifications have been made to reduce the indexation for the 2025-26 financial year to prevent a compounded impact on the indexation of these annual charges. These increases are in line with the TGA’s cost recovery model.
The Amendment Regulations complement the Therapeutic Goods Legislation Amendment (Fees) Regulations 2025 which, among other things, increases most fees for therapeutic goods for 2025-26 by 3.2 per cent indexation rate.
Human rights implications
As the 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