The Therapeutic Goods Amendment Bill 2025 replaces subsection 63(4) of the Therapeutic Goods Act 1989 to permit regulations made under that Act to apply, adopt or incorporate any matter contained in an instrument or other writing “as in force or existing from time to time,” notwithstanding subsection 14(2) of the Legislation Act 2003. The new text explicitly allows incorporation with or without modification and to treat external materials as dynamic references.
This change shortens the administrative path for technical or standards-based material to become part of the regulatory framework for therapeutic goods. It matters to manufacturers, sponsors, standards bodies and the Therapeutic Goods Administration (TGA) because it alters how standards are referenced, updated, accessed and enforced — with consequences for legal certainty, transparency and compliance costs.
At a Glance
What It Does
The bill substitutes subsection 63(4) to allow regulations under the Therapeutic Goods Act to incorporate external instruments or writings and to treat those documents as in force or existing from time to time. It explicitly operates despite subsection 14(2) of the Legislation Act 2003 and permits incorporation with or without modification.
Who It Affects
This change directly affects the TGA, medical device and medicine sponsors and manufacturers, standards organisations whose documents may be referenced, and legal/compliance teams that must track and implement evolving external standards. Indirectly it affects healthcare providers and patients through how quickly technical requirements can change.
Why It Matters
By enabling dynamic incorporation, the bill speeds adoption of technical standards without reissuing primary regulations, but it shifts the burden of tracking changes to regulated parties and raises transparency and scrutiny issues because referenced materials can change without Parliament re‑approving the exact text.
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What This Bill Actually Does
The bill makes one targeted change to the Therapeutic Goods Act: it rewrites subsection 63(4) so that regulations may adopt or incorporate material from external instruments or other writings and treat those materials as if they are in force 'from time to time.' Practically, that means a regulation can point to a standard, guidance document or other external text and say the current version of that text (and future versions) form part of the regulatory requirements.
The amendment expressly overrides subsection 14(2) of the Legislation Act 2003. That reference matters because the Legislation Act sets out general rules about how instruments become law and how they must be published.
By stating 'despite subsection 14(2),' the bill carves out an exception for the Therapeutic Goods Act's regulations, giving them broader permissive power to incorporate external material dynamically.For regulated entities, the change reduces the need for the TGA to amend regulations each time a technical standard is updated; instead the regulation can point to an external standard and rely on that standard's amendments to take effect automatically. That creates a faster pathway for updating technical requirements but means companies must monitor the sources of those standards continuously.
It also raises questions about access: if the external instrument is behind a paywall or not widely distributed, regulated parties and the public may find it harder to know what the law requires at any given time.The bill’s other clauses are procedural: a short title, a commencement provision that brings the Act into force the day after Royal Assent and the schedule that carries the amendment. The substantive policy effect therefore rests solely on the new wording of subsection 63(4) and its interaction with existing publication and transparency norms in the Legislation Act.
The Five Things You Need to Know
The bill replaces subsection 63(4) of the Therapeutic Goods Act 1989 with language permitting regulations to apply, adopt or incorporate external instruments or other writings 'as in force or existing from time to time.', It explicitly states the new power operates 'despite subsection 14(2) of the Legislation Act 2003,' creating a statutory exception for the Therapeutic Goods Act's regulations.
The substituted provision allows incorporation either 'with or without modification,' giving regulators flexibility to adapt external material when referencing it.
Commencement is immediate: the Act takes effect the day after it receives Royal Assent, so the new incorporation power will be available to the TGA as soon as the Act commences.
The amendment is narrowly framed in Schedule 1 and does not itself set criteria for access, notification, or parliamentary oversight of the externally incorporated materials.
Section-by-Section Breakdown
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Short title
Establishes the Act’s formal name as the Therapeutic Goods Amendment Act 2025. It is procedural but signals that the measure is an amendment act rather than a standalone reform package.
Commencement timing
Specifies the Act comes into force the day after Royal Assent. That immediacy matters because any regulatory instruments drafted or revised by the TGA after commencement can rely on the new incorporation power without further legislative action.
New incorporation power for Therapeutic Goods regulations
Replaces the old subsection with wording that lets regulations under the Therapeutic Goods Act adopt external instruments or other writings 'as in force or existing from time to time' and permits modification when incorporating. By expressly operating 'despite subsection 14(2) of the Legislation Act 2003,' it creates an exception to general rules limiting incorporation by reference. Practically, this provision gives the TGA a straightforward mechanism to bind regulated parties to standards or texts maintained outside the primary statute, enabling faster technical updates but shifting how legal text will be accessed and interpreted.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Therapeutic Goods Administration (TGA) — Gains administrative flexibility to update technical requirements by referencing external standards rather than amending regulations each time, reducing drafting and legislative lead time.
- Standards organisations (e.g., standards-development bodies) — See faster uptake of their technical standards into enforceable regulation, increasing the market relevance and influence of their documents.
- Large manufacturers and sponsors with robust compliance teams — Benefit from quicker regulatory alignment with evolving technical norms because the path to legal effect for updated standards is shortened.
- Patients and clinicians (potentially) — May benefit indirectly when safety or performance standards can be updated and enforced more quickly in response to new evidence or technology.
Who Bears the Cost
- Small and medium-sized manufacturers — Face higher compliance risk and monitoring costs because they must track changes in externally referenced materials that can alter legal obligations without separate regulatory amendments.
- Parliamentary scrutiny bodies and parliamentarians — Lose some visibility and direct control over the exact text that becomes binding since the Act allows dynamic incorporation, complicating oversight.
- Legal advisers, courts and tribunals — Confront greater interpretive complexity when deciding which version of an incorporated instrument applies at a given time and whether modifications were validly applied.
- Public and patient advocates — May face reduced practical access to binding regulatory requirements if incorporated materials are behind paywalls or not centrally published, raising transparency and accountability costs.
Key Issues
The Core Tension
The central dilemma is between regulatory agility and democratic/legal safeguards: the bill speeds the incorporation of technical standards into binding rules, but it does so by moving authoritative legal content outside primary legislation and the usual publication regimes, which raises legitimate concerns about transparency, parliamentary oversight and legal certainty.
The amendment trades off legislative certainty for regulatory agility. Allowing regulations to incorporate external material 'as in force from time to time' reduces friction for updating technical rules, but it also means the binding legal text can move outside the statute and into documents that may not be freely or centrally accessible.
That raises concrete problems: which version applies at a particular date; how will the TGA notify regulated parties of changes; and what happens when an incorporated standard is subject to copyright or commercial distribution restrictions?
The bill also creates a tension between the Legislation Act’s publication and validation regime and the Therapeutic Goods Act’s new exception. The Legislation Act sets norms to preserve transparency and parliamentary oversight; carving out an exception concentrates decision-making in delegated instruments.
Implementation choices (for example, whether the TGA will publish copies of incorporated materials, establish version-tracking, or require public notices) will determine whether the efficiency gains materialise without undermining legal clarity and access to law. Finally, courts may face disputes about how and when an incorporated text is enforceable — particularly where a referenced document is modified by a third party and that modification has material effects on safety or compliance obligations.
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