Sponsor speech Supports
Rebecca White
Rebecca White supports the bill, saying it will allow grouped biologicals to share a register entry and reduce costs and regulatory burden for industry.
Read in Hansard ↗Therapeutic Goods (Charges) Amendment
Current status
This bill is currently before Parliament.
Policy area
Health, care & disability
What does this bill do?
Sponsors — businesses responsible for therapeutic products — can group similar biological products under one register entry and pay one annual chargeA yearly industry fee funding regulatory work..
Why was it introduced?
The government said grouping similar biological products would reduce duplicated paperwork and multiple annual charges for industry. The Therapeutic Goods Administration, the national medicines and medical-products regulator, consulted around 40 stakeholders from 6 to 20 November 2025 and reported overall support. The government expects the combined reforms to reduce the regulator’s revenue by $0.2 million over three years from 2027–28.
Broader context
Existing rules made sponsors register similar biological products separately and pay annual charges for each inclusion, while TGA charges were designed to recover the cost of post-market monitoringSafety and compliance checks after approval.. After targeted consultation in November 2025 supported grouping to reduce duplication, Rebecca White MP introduced the bill on 2 July 2026 to let similar products share one register entry and charge, with the change tied to companion medicines-shortages legislation that would create those grouped entries.
Key criticism
The evidence pack does not contain criticism from an opposition or crossbench speaker. Rebecca White (Australian Labor Party) introduced the bill, outlined its purpose and said it would reduce industry costs and paperwork before the debate was adjourned.
Who supported it?
Rebecca White MP introduced this bill. Supportive speeches so far have come from Labor.
Introduced in House 02 July 2026
At second reading in House 02 July 2026
Not yet reached Senate —
Not yet law —
Did it become law?
Not yet
Final passage
No final vote yet
The bill has not yet completed passage through Parliament.
Days since introduction
36 days
Updated 07 Aug 2026.
Meaning
What does this bill do?
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Sponsors — businesses responsible for therapeutic products — can group similar biological products under one register entry and pay one annual chargeA yearly industry fee funding regulatory work..
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Sponsors with a grouped entry must pay the full annual chargeA yearly industry fee funding regulatory work. if that entry operates at any time during the financial year.
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Sponsors will have their charge set through regulationsDetailed legal rules made under an Act., with the amount reflecting the monitoring work required for each product class.
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Sponsors and industry groups must be consulted before charge amounts are set. Either house of Parliament can reject the regulationsDetailed legal rules made under an Act..
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Sponsors will face the new charge from the first financial year starting on or after the changes begin.
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Sponsors will not face these changes unless the related medicines-shortages law also begins.
Show source excerpts
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After “a biological”, insert “, other than grouped biologicals,”. 2 After subsection 4(1AA) (1AB) If the inclusion of one or more grouped biologicals, being biologicals covered by a single biological number, in the Register under Part 3‑2A of the Therapeutic Goods Act has effect at any time during a financial year, an annual charge of such amount as is prescribed is payable in respect of all of the biologicals concerned.
Therapeutic Goods (Charges) Amendment introduced text -
2 After subsection 4(1AA) (1AB) If the inclusion of one or more grouped biologicals, being biologicals covered by a single biological number, in the Register under Part 3‑2A of the Therapeutic Goods Act has effect at any time during a financial year, an annual charge of such amount as is prescribed is payable in respect of all of the biologicals concerned.
Therapeutic Goods (Charges) Amendment introduced text -
2 After subsection 4(1AA) (1AB) If the inclusion of one or more grouped biologicals, being biologicals covered by a single biological number, in the Register under Part 3‑2A of the Therapeutic Goods Act has effect at any time during a financial year, an annual charge of such amount as is prescribed is payable in respect of all of the biologicals concerned.
Therapeutic Goods (Charges) Amendment introduced text -
As a legislative instrument, the regulations prescribing the amounts of annual charges in respect of the inclusion of grouped biologicals in the Register will be subject to the requirements of the Legislation Act 2003, including those relating to consultation and parliamentary scrutiny. Before prescribing amounts of annual charges, the TGA will consult relevant stakeholders, such as sponsors and industry peak bodies. In addition, the regulations will be required to be tabled in Parliament and will be subject to disallowance by either House. This provides an additional mechanism for parliamenta
Therapeutic Goods (Charges) Amendment explanatory memorandum -
Item 3 – Application provision This item provides that new subsection 4(1AB) of the Charges Act applies in relation to the financial year starting on or after the commencement of this item.
Therapeutic Goods (Charges) Amendment explanatory memorandum -
1. The whole of this Act At the same time as the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Act 2026 commences. However, the provisions do not commence at all if that Act does not commence.
Therapeutic Goods (Charges) Amendment introduced text
Context
Broader context for this bill
Existing rules made sponsors register similar biological products separately and pay annual charges for each inclusion, while TGA charges were designed to recover the cost of post-market monitoringSafety and compliance checks after approval.. After targeted consultation in November 2025 supported grouping to reduce duplication, Rebecca White MP introduced the bill on 2 July 2026 to let similar products share one register entry and charge, with the change tied to companion medicines-shortages legislation that would create those grouped entries.
- 6–20 Nov 2025
TGA consults on grouping similar biologicals
Feedback from about 40 stakeholders was positive and supported grouping similar biologicals under one Register entry to reduce duplication.
Therapeutic Goods (Charges) Amendment explanatory memorandum ↗ - 02 July 2026
Companion bill would create grouped biological entries
The related Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 would enable similar biologicals to share a single Register entry, making this charging bill dependent on that legislation commencing.
Therapeutic Goods (Charges) Amendment explanatory memorandum ↗ - 02 July 2026
Rebecca White MP introduces the bill
The bill was introduced in the House of Representatives to allow regulationsDetailed legal rules made under an Act. to set an annual chargeA yearly industry fee funding regulatory work. for one or more grouped biologicals covered by a single biological number.
Parliamentary timeline ↗
Legislative route
How did it move through Parliament?
House Senate
Introduced 02 July 2026
The bill was formally presented to the chamber and read a first time, which starts its parliamentary journey.
Introduced and read a first time
Second reading opened 02 July 2026
A minister or sponsoring member moved the second reading, opening the main debate on the bill's purpose and principles.
Second reading moved
Community Affairs review 02 July 2026
Referred to Committee (02/07/2026): Senate Community Affairs Legislation Committee; Report due 01/09/2026
Report due 01 Sep 2026
APH bill page notesKey criticism
The main case against this bill
The evidence pack does not contain criticism from an opposition or crossbench speaker. Rebecca White (Australian Labor Party) introduced the bill, outlined its purpose and said it would reduce industry costs and paperwork before the debate was adjourned.
The government’s explanatory memorandum says consultation feedback was broadly positive and that no concerns were raised about allowing regulationsDetailed legal rules made under an Act. to set the grouped-product charge. It also says the bill places no upper limit on that charge, while Parliament can reject the regulationsDetailed legal rules made under an Act. that set it.
Further sources
Votes
Recorded votes
No recorded votes have been found yet for this bill.
Parliamentary debate
Who spoke, and what they said
Start here — lead voices
All speeches by bloc
Labor
1 speaker · 1 support
Labor
1 speaker · 1 support
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Rebecca White ★ Rebecca White supports the bill, saying it will allow grouped biologicals to share a register entry and reduce costs and regulatory burden for industry.
“The amendments made by this bill, together with the associated amendments in the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026, will reduce costs and regulatory burden for industry.”
Read the full speech in Hansard ↗
Record
Full record
- Status
- Before Reps -- Collected from the APH bill page.
- Originating house
- House of Representatives
- 02 July 2026
House · Introduced and read a first time
Introduced
The bill was formally presented to the chamber and read a first time, which starts its parliamentary journey.
- 02 July 2026
House · Second reading moved
Second reading opened
A minister or sponsoring member moved the second reading, opening the main debate on the bill's purpose and principles.
Senate Community Affairs Legislation Committee
Report due 01 Sep 2026
Referred to Committee (2 July 2026): Senate Community Affairs Legislation Committee; Report due 1 Sept 2026
APH bill page notes