Medicine rules could keep up with changing standards
This is a one-line fix to the main medicines law. It would let health rules borrow from other written papers as those papers change, such as overseas standards.
Official name: Therapeutic Goods Amendment Bill 2025
- It changes one small part of the law that controls medicines and medical products.
- Medicine rules could copy in rules from any written paper, as that paper is updated.
- The government says this keeps Australian rules in step with Europe and the US.
- The bill was brought in during July 2025 and has not moved since.
Who it affects
- Companies that make or sell medicines and medical devices: Their rules could follow overseas or technical papers as those papers change.
- Patients: The government says matching overseas rules may stop companies holding back new products here.
- Everyone else: Nothing changes in daily life.
Copying standards in is slow
The Therapeutic Goods Act is the main law for medicines in Australia. It also covers medical devices and vapes. The medicines watchdog runs it. That is the national agency that checks medicines are safe and work.
Much of the detail is not in the Act itself. It sits in detailed rules the government writes without a new vote in Parliament.
Sometimes one of these rules needs to use parts of another paper. An example is a world standard for a lab test. Copying the whole thing in takes a long time. So the law lets a rule point to the other paper. Lawyers call this "incorporating by reference".
There is a catch. A general law, the Legislation Act, sets limits on this. It covers how all national rules are made. It says a rule can only point to a paper as it was on one date. To follow the paper as it changes, the main law must clearly allow it.
The one change
Right now, section 63(4) of the Therapeutic Goods Act lets the rules follow "an instrument" as it changes. An instrument is a formal legal paper, such as another set of rules. The section does not mention "other writing". That could be a standard put out by an overseas group.
The bill rewrites section 63(4) so it covers both. The rules could then use any legal paper or other writing as it stands at the time. They could use it as it is, or with changes. The government says this matches other parts of the Act and the Legislation Act.
Say a European group updates a test for a type of medical device. An Australian rule might point to that test. If so, the Australian rule would update with it on its own.
Why the government wants it
The government says this keeps our medicine rules in line with big markets. It names the European Union and the United States.
It says that if our rules are very different, some companies may wait to bring new products here. That could hurt patients.
Any rule that uses this power would still be open for the public to comment on. Parliament could still vote it down. The government expects most of the outside papers to be free to read. It says some technical ones may not be free.
Start date
If it passes, the whole bill would start the day after it becomes law. A bill becomes law when the Governor-General signs it. The Governor-General is the King's representative in Australia.
The bill was brought into the House of Representatives on 22 July 2025, under the Prime Minister's name. That is the house of Parliament where the government sits. That day it had its first reading, the formal first step for a bill.
Since then there has been no debate or vote. To become law it would still need to pass the House of Representatives. It would then need to pass the Senate, the other house of Parliament.
Its journey through Parliament
| 22 Jul 2025 | House of Representatives: Introduced and read a first time |