This bill is currently before Parliament.
Health, care & disability
Sponsors of similar biologicalA therapeutic product covered by the biologicals rules. products can pay one annual chargeA fee payable for a financial year. when those products share one entry in Australia’s therapeutic goods register.
The government says grouping similar biologicalA therapeutic product covered by the biologicals rules. products under one register entry will reduce duplication, costs and paperwork for industry. The Therapeutic Goods Administration, the health department body that regulates therapeutic goods, consulted around 40 stakeholders from 6 to 20 November 2025. The government expects this bill and the related reforms to reduce that agency’s revenue by $0.2 million over three years from 2027–28.
Before 2026, similar biologicalA therapeutic product covered by the biologicals rules. medicines had to have separate entries in the Australian Register of Therapeutic GoodsThe register where regulated therapeutic goods are recorded., so sponsors paid multiple annual charges even where products could be grouped and the TGA still needed to recover post-market monitoringSafety and compliance checks after market entry. and compliance costs. After targeted stakeholder consultation in November 2025 supported grouping, Rebecca White MP introduced this bill on 2 July 2026 alongside related medicines-shortage reforms; the House passed it on 12 August, but its charging changes depend on that related Act commencing.
The evidence pack contains no criticism from an opposition or crossbench speaker. Its parliamentary material records only the bill’s introduction, the government’s explanation and the adjournment of debate.
Rebecca White MP introduced this bill. Supportive speeches so far have come from Labor.
Did it become law?
Not yet
Final passage
No final vote yet
The bill has not yet completed passage through Parliament.
Days since introduction
96 days
Updated 06 Oct 2026.
Meaning
Sponsors of similar biologicalA therapeutic product covered by the biologicals rules. products can pay one annual chargeA fee payable for a financial year. when those products share one entry in Australia’s therapeutic goods register.
Sponsors with a grouped entry owe the annual chargeA fee payable for a financial year. if that entry is active at any time during the financial year.
Sponsors will have their charge set through regulationsDetailed rules made under an Act. — detailed rules made under an Act — rather than in the bill itself.
Sponsors can expect charges to reflect the cost of safety monitoring and other checks after products enter the market.
Sponsors will face the new charge from the first financial year beginning on or after the measure starts.
Sponsors will see no change unless the related Medicines Shortages and Other Measures Act 2026 also starts.
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
Different levels of post-market monitoring are required for different classes of therapeutic goods depending on the level of risk the good could pose. The amounts of annual charges prescribed in the regulations for the purposes of new subsection 4(1AB) of the Charges Act in respect of the inclusion of grouped biologicals in the Register will reflect the level of pharmacovigilance and post-market work required (and associated costs) and will be set in accordance with the Australian Government Cost Recovery Policy. It is appropriate to leave the setting of the amounts of annual charges for theTherapeutic 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
Before 2026, similar biologicalA therapeutic product covered by the biologicals rules. medicines had to have separate entries in the Australian Register of Therapeutic GoodsThe register where regulated therapeutic goods are recorded., so sponsors paid multiple annual charges even where products could be grouped and the TGA still needed to recover post-market monitoringSafety and compliance checks after market entry. and compliance costs. After targeted stakeholder consultation in November 2025 supported grouping, Rebecca White MP introduced this bill on 2 July 2026 alongside related medicines-shortage reforms; the House passed it on 12 August, but its charging changes depend on that related Act commencing.
TGA consults stakeholders on grouping biologicalA therapeutic product covered by the biologicals rules. medicines
The TGA consulted around 40 stakeholders, who supported grouping similar biologicalA therapeutic product covered by the biologicals rules. medicines under one Register entry to reduce duplication and costs.
Therapeutic Goods (Charges) Amendment explanatory memorandum ↗Rebecca White MP introduces the bill
The bill was introduced in the House alongside related medicines-shortage reforms to allow grouped biologicalA therapeutic product covered by the biologicals rules. medicines to share one Register entry and annual chargeA fee payable for a financial year..
Hansard ↗House passes the bill
The House agreed to the third reading, completing passage through that chamber while the charging changes remained dependent on commencement of the related medicines-shortage Act.
Parliamentary timeline ↗Legislative route
The bill was formally presented to the chamber and read a first time, which starts its parliamentary journey.
Introduced and read a first time
A minister or sponsoring member moved the second reading, opening the main debate on the bill's purpose and principles.
Second reading moved
Referred to Committee (02/07/2026): Senate Community Affairs Legislation Committee; Report due 01/09/2026
Report due 01 Sep 2026
APH bill page notesThe bill reached this recorded parliamentary step.
The bill reached this recorded parliamentary step.
Referred to Federation Chamber
The bill reached this recorded parliamentary step.
Second reading debate
The chamber agreed to the bill at second reading, meaning it accepted the bill in principle and allowed it to continue.
Second reading agreed to
The bill reached this recorded parliamentary step.
Reported from Federation Chamber
The chamber agreed to the bill at third reading, which completed passage through that chamber.
Third reading agreed to
The bill was formally presented to the chamber and read a first time, which starts its parliamentary journey.
Introduced and read a first time
A minister or sponsoring member moved the second reading, opening the main debate on the bill's purpose and principles.
Second reading moved
Key criticism
The evidence pack contains no criticism from an opposition or crossbench speaker. Its parliamentary material records only the bill’s introduction, the government’s explanation and the adjournment of debate.
The explanatory memorandum says feedback from around 40 consulted stakeholders was generally positive, and no concerns were raised about allowing regulationsDetailed rules made under an Act. to set the grouped charge.
Further sources
Votes
No recorded votes have been found yet for this bill.
Parliamentary debate
Start here — lead voices
White supports the bill, saying it will allow annual charges for grouped biologicalsSimilar biological products sharing one register entry. and, with related reforms, reduce industry costs and regulatory burden.
Read in Hansard ↗All speeches by bloc
1 speaker · 1 support
“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
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.
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.
House · Second reading debate
Second reading debate
The bill reached this recorded parliamentary step.
House · Referred to Federation Chamber
Referred to Federation Chamber
The bill reached this recorded parliamentary step.
House · Second reading debate
Second reading debate
The bill reached this recorded parliamentary step.
House · Second reading agreed to
Second reading agreed
The chamber agreed to the bill at second reading, meaning it accepted the bill in principle and allowed it to continue.
House · Reported from Federation Chamber
Reported from Federation Chamber
The bill reached this recorded parliamentary step.
House · Third reading agreed to
Third reading agreed
The chamber agreed to the bill at third reading, which completed passage through that chamber.
Senate · 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.
Senate · 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