Therapeutic Goods Amendment
Current status
This bill is currently before Parliament.
Policy area
Health, care & disability
What does this bill do?
The bill would make one technical amendment to the Therapeutic Goods Act 1989The Commonwealth law for regulating therapeutic goods in Australia. This bill would amend subsection 63(4) of that Act., replacing subsection 63(4).
Why was it introduced?
The bill was introduced to fix a narrow wording gap in subsection 63(4) of the Therapeutic Goods ActThe Commonwealth law for regulating therapeutic goods in Australia. This bill would amend subsection 63(4) of that Act.. The explanatory memorandum says the current provision refers to regulationsDetailed legal rules made under an Act of Parliament. This bill is about what Therapeutic Goods Act regulations may refer to. incorporating material from instruments, but does not expressly refer to other writingWritten material that is not described as an instrument. The bill would expressly allow Therapeutic Goods Act regulations to refer to this kind of material.. The government says adding other writingWritten material that is not described as an instrument. The bill would expressly allow Therapeutic Goods Act regulations to refer to this kind of material. would align the provision with other parts of the Therapeutic Goods ActThe Commonwealth law for regulating therapeutic goods in Australia. This bill would amend subsection 63(4) of that Act. and the Legislation Act 2003, and may help Australia's therapeutic goodsHealth-related goods regulated for matters such as quality, safety, efficacy or performance and timely availability. rules stay up to date with technical or scientific material used in major markets such as the European Union and the United States.
Broader context
This is a small regulatory-maintenance bill rather than a broad health-policy reform. The Therapeutic Goods ActThe Commonwealth law for regulating therapeutic goods in Australia. This bill would amend subsection 63(4) of that Act. already provides national controls for therapeutic goodsHealth-related goods regulated for matters such as quality, safety, efficacy or performance and timely availability. and vaping goods, and the amendment focuses on how regulationsDetailed legal rules made under an Act of Parliament. This bill is about what Therapeutic Goods Act regulations may refer to. can refer to external material. The government's stated reason is practical: some therapeutic-goods rules may need to track technical, scientific or overseas benchmark material as it changes, while still going through consultation, disallowanceA parliamentary process that can stop a legislative instrument from continuing to operate. The explanatory memorandum says regulations using this power would remain subject to that process. and impact-analysis processes.
Key criticism
The local source bundle does not contain substantive public criticism, opposition speeches, scrutiny concerns or media coverage about this bill. The official explanatory memorandum itself flags two limits: regulationsDetailed legal rules made under an Act of Parliament. This bill is about what Therapeutic Goods Act regulations may refer to. using the amended power would still go through consultation, disallowanceA parliamentary process that can stop a legislative instrument from continuing to operate. The explanatory memorandum says regulations using this power would remain subject to that process. and impact analysis, and referenced writing is expected to be freely available where possible but may not always be freely available where technical or scientific benchmark documents are involved.
Who supported it?
Prime Minister Anthony Albanese MP introduced this bill.
Did it become law?
Not yet
Final passage
No final vote yet
The bill has not yet completed passage through Parliament.
Days since introduction
323 days
Updated 10 June 2026.
Meaning
What does this bill do?
-
The bill would make one technical amendment to the Therapeutic Goods Act 1989The Commonwealth law for regulating therapeutic goods in Australia. This bill would amend subsection 63(4) of that Act., replacing subsection 63(4).
-
It would make clear that regulationsDetailed legal rules made under an Act of Parliament. This bill is about what Therapeutic Goods Act regulations may refer to. under the Therapeutic Goods ActThe Commonwealth law for regulating therapeutic goods in Australia. This bill would amend subsection 63(4) of that Act. can apply, adopt or incorporateA legal drafting method where regulations use material from another document instead of restating all of that material in the regulation itself. material from an instrumentA formal legal or technical document that regulations may apply, adopt or incorporate by reference. or other writingWritten material that is not described as an instrument. The bill would expressly allow Therapeutic Goods Act regulations to refer to this kind of material., as that material exists or changes from time to time.
-
The current subsection already refers to instruments, but the explanatory memorandum says it does not expressly cover other writingWritten material that is not described as an instrument. The bill would expressly allow Therapeutic Goods Act regulations to refer to this kind of material. on the same basis.
-
The government says the change would better align subsection 63(4) with other Therapeutic Goods ActThe Commonwealth law for regulating therapeutic goods in Australia. This bill would amend subsection 63(4) of that Act. provisions and with the Legislation Act 2003.
-
The explanatory memorandum says the change may help keep Australia's therapeutic goodsHealth-related goods regulated for matters such as quality, safety, efficacy or performance and timely availability. rules up to date with key jurisdictions such as the European Union and the United States, reducing the risk that sponsors delay bringing products to Australia.
-
The explanatory memorandum says regulationsDetailed legal rules made under an Act of Parliament. This bill is about what Therapeutic Goods Act regulations may refer to. using this power would still be subject to Legislation Act consultation and disallowanceA parliamentary process that can stop a legislative instrument from continuing to operate. The explanatory memorandum says regulations using this power would remain subject to that process. requirements, impact analysis, and no specific financial implications are expected from the bill.
Show source excerpts
-
Therapeutic Goods Act 1989 1 Subsection 63(4) Repeal the subsection, substitute:
Therapeutic Goods Amendment introduced bill text -
the regulations may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.
Therapeutic Goods Amendment introduced bill text -
Currently subsection 63(4) only refers to matters contained in an instrument in this respect, and does not refer to matters in other writing.
Therapeutic Goods Amendment explanatory memorandum -
This would align subsection 63(4) with similar provisions in the Therapeutic Goods Act, including for example subsection 10(4), and with the terms of subsection 14(2) of the Legislation Act.
Therapeutic Goods Amendment explanatory memorandum -
It may be necessary for regulations made under the Therapeutic Goods Act to make provision for matters contained in an instrument or other writing as existing from time to time... to ensure that Australia's regulatory scheme for therapeutic goods remains up to date and not out of alignment with other key jurisdictions, such as the European Union and the United States.
Therapeutic Goods Amendment explanatory memorandum -
any proposed amendments to the regulations... would be subject to the requirements in the Legislation Act in relation to consultation and the disallowance process, and the impact analysis process. Financial Impact Statement There are no specific financial implications resulting from the Bill.
Therapeutic Goods Amendment explanatory memorandum
Context
Broader context for this bill
This is a small regulatory-maintenance bill rather than a broad health-policy reform. The Therapeutic Goods ActThe Commonwealth law for regulating therapeutic goods in Australia. This bill would amend subsection 63(4) of that Act. already provides national controls for therapeutic goodsHealth-related goods regulated for matters such as quality, safety, efficacy or performance and timely availability. and vaping goods, and the amendment focuses on how regulationsDetailed legal rules made under an Act of Parliament. This bill is about what Therapeutic Goods Act regulations may refer to. can refer to external material. The government's stated reason is practical: some therapeutic-goods rules may need to track technical, scientific or overseas benchmark material as it changes, while still going through consultation, disallowanceA parliamentary process that can stop a legislative instrument from continuing to operate. The explanatory memorandum says regulations using this power would remain subject to that process. and impact-analysis processes.
- 1989
Therapeutic goodsHealth-related goods regulated for matters such as quality, safety, efficacy or performance and timely availability. law sets national controls
The explanatory memorandum describes the Therapeutic Goods Act 1989The Commonwealth law for regulating therapeutic goods in Australia. This bill would amend subsection 63(4) of that Act. as the law establishing national controls for the quality, safety, efficacy or performance and timely availability of therapeutic goodsHealth-related goods regulated for matters such as quality, safety, efficacy or performance and timely availability. used in or exported from Australia, as well as controls for vaping goods.
Explanatory memorandum ↗ - Before 2025
Subsection 63(4) names instruments only
The explanatory memorandum says the existing subsection 63(4) lets regulationsDetailed legal rules made under an Act of Parliament. This bill is about what Therapeutic Goods Act regulations may refer to. incorporate material from instruments, but does not expressly refer to other writingWritten material that is not described as an instrument. The bill would expressly allow Therapeutic Goods Act regulations to refer to this kind of material. on the same basis.
Explanatory memorandum ↗ - 22 July 2025
Government introduces other-writing amendment
The bill was introduced in the House of Representatives to add other writingWritten material that is not described as an instrument. The bill would expressly allow Therapeutic Goods Act regulations to refer to this kind of material. to the material that Therapeutic Goods ActThe Commonwealth law for regulating therapeutic goods in Australia. This bill would amend subsection 63(4) of that Act. regulationsDetailed legal rules made under an Act of Parliament. This bill is about what Therapeutic Goods Act regulations may refer to. can apply, adopt or incorporateA legal drafting method where regulations use material from another document instead of restating all of that material in the regulation itself. as in force or existing from time to time.
Parliament of Australia ↗ - 22 July 2025
Explanatory material emphasises safeguards
The explanatory memorandum says regulationsDetailed legal rules made under an Act of Parliament. This bill is about what Therapeutic Goods Act regulations may refer to. relying on the amended power would still be subject to Legislation Act consultation and disallowanceA parliamentary process that can stop a legislative instrument from continuing to operate. The explanatory memorandum says regulations using this power would remain subject to that process. requirements and the impact-analysis process.
Explanatory memorandum ↗
Legislative route
How did it move through Parliament?
Introduced 22 July 2025
The bill was formally presented to the House of Representatives and read a first time.
Introduced and read a first time
Key criticism
The main case against this bill
The local source bundle does not contain substantive public criticism, opposition speeches, scrutiny concerns or media coverage about this bill. The official explanatory memorandum itself flags two limits: regulationsDetailed legal rules made under an Act of Parliament. This bill is about what Therapeutic Goods Act regulations may refer to. using the amended power would still go through consultation, disallowanceA parliamentary process that can stop a legislative instrument from continuing to operate. The explanatory memorandum says regulations using this power would remain subject to that process. and impact analysis, and referenced writing is expected to be freely available where possible but may not always be freely available where technical or scientific benchmark documents are involved.
This does not prove the bill faced no criticism; it means the supplied local sources do not include enough criticism material to write fact-grounded criticism cards.
Further sources
Votes
Recorded votes
No recorded votes have been found yet for this bill.
Parliamentary debate
Who spoke, and what they said
No speeches were found for this bill.
Record
Full record
- Status
- Before Reps -- Collected from the APH bill page.
- Originating house
- House of Representatives
- Bill type
- Government bill -- The APH metadata lists the bill as a government bill in the Prime Minister portfolio.
- Source coverage
- Official sources only -- The local source bundle contains the introduced bill text and explanatory memorandum, but no collected speeches, divisions, amendments, scrutiny notes or media context.
- 22 July 2025
House · Introduced and read a first time
Introduced
The bill was formally presented to the House of Representatives and read a first time.