The short answer

Therapeutic Goods (Charges) Amendment Bill 2026: what it would change and who it affects

The Therapeutic Goods (Charges) Amendment Bill 2026 is a government bill that amends the Therapeutic Goods (Charges) Act 1989 to allow annual charges to be prescribed for grouped biological entries in the Australian Register of Therapeutic Goods (ARTG). Introduced on 2 July 2026 by the Assistant Minister for Health and Aged Care, the bill is a companion to broader TGA reforms and passed the House of Representatives on 12 August 2026 and was introduced and read a first time in the Senate the same day, where the second reading was moved. It is now before the Senate, with a Senate committee report due 1 September 2026. It has not yet been enacted. According to the official summary on the Parliament bill page, the bill was introduced with the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 and enables annual charges to be prescribed for the inclusion of grouped biologicals in the Australian Register of Therapeutic Goods.

This is a federal system guide. State constitutions, parliaments and local-government laws can allocate comparable functions differently.

The useful question is not only “what is the rule?” but also “who administers it, which document controls it, and when might it change?” That distinction prevents an accurate general explanation from becoming wrong advice in a particular election, chamber or policy setting.

Evidence review

What the bill is and why it was introduced

The Therapeutic Goods (Charges) Amendment Bill 2026 was introduced into the House of Representatives on 2 July 2026 by Rebecca White MP, Assistant Minister for Health and Aged Care. It is a government bill under the Health, Disability and Ageing portfolio.

The bill amends the Therapeutic Goods (Charges) Act 1989 — the legislation that sets the charging framework for therapeutic goods regulation in Australia. It does not amend the Therapeutic Goods Act 1989 itself; that change is being made by a companion bill, the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026. The official summary on the Parliament bill page confirms the bill was introduced with that companion bill.

The core purpose is narrow but practical: to permit annual charges to be imposed for "grouped biologicals" — a new category of entry on the Australian Register of Therapeutic Goods (ARTG). Without this amendment, the existing charging framework would not accommodate the grouped entry model the companion bill creates.

Evidence review

The grouped biologicals mechanism

Currently, each biological therapeutic good must have its own separate ARTG entry, attracting separate annual charges. The companion bill empowers the Secretary of the Department of Health to determine that similar biologicals may be grouped together and share a single ARTG entry.

A "biological" in this context means a therapeutic good that is derived from or produced by a living organism — such as vaccines, blood products, cellular therapies and recombinant proteins. Grouping similar biologicals simplifies the regulatory pathway.

The effect for industry is lower administrative and fee costs, because a manufacturer or sponsor no longer needs to maintain and pay for multiple ARTG entries for closely related products. For the TGA, it reduces duplication in the register and streamlines assessment processes.

Evidence review

Current parliamentary status

The bill was introduced and read a first time in the House of Representatives on 2 July 2026, and the second reading was moved the same day. The House agreed to the second reading on 12 August 2026 after consideration in the Federation Chamber, and the bill was read a third time the same day, so it passed the House of Representatives on 12 August 2026 without amendment.

The bill was introduced and read a first time in the Senate on 12 August 2026, with the second reading moved the same day. It is now before the Senate. It was referred to the Senate Community Affairs Legislation Committee for inquiry on 2 July 2026, with the committee required to report by 1 September 2026.

Before the bill becomes law it must complete second reading debate and passage in the Senate and receive Royal Assent from the Governor-General.

Evidence review

Who is affected

The bill directly affects sponsors and manufacturers of biological therapeutic goods who will benefit from the grouped entry pathway and the associated charging structure. It also affects the Therapeutic Goods Administration, which will need to implement the new charging categories.

Indirectly, healthcare providers and consumers may be affected through any improvements in the regulatory environment — for example, if reduced costs encourage more biological products to be registered in Australia, or if streamlined regulation accelerates access to certain biological medicines.

The bill does not change the safety, quality or efficacy standards that biologicals must meet. Those requirements remain governed by the Therapeutic Goods Act 1989 and associated regulations.

Evidence review

Evidence base and uncertainty

The bill is supported by an Explanatory Memorandum that explains the interaction between the charging amendment and the grouped biologicals framework. The Minister's second reading speech, delivered on 2 July 2026, frames the bill as a technical adjustment that enables the broader TGA reform package.

There are no published Bills Digest, regulatory impact statement or independent costings for this specific charging amendment, which is typical for a bill of this narrow scope. The substantive policy case for grouped biologicals rests with the companion bill, not this one.

The main uncertainty is whether the Senate committee inquiry will raise any issues about the charging rates to be set by regulation. The bill itself does not prescribe dollar amounts — it enables regulations to set the annual charges. The level of those charges will matter to industry and has not yet been published.

Evidence review

Chamber record cross-check — 2 July 2026

The House of Representatives Live Minutes record for 2026-07-02 lists Therapeutic Goods (Charges) Amendment Bill 2026. That listing is evidence of chamber activity on the sitting day, but it is not by itself evidence that the bill passed both houses, received Royal Assent or commenced. The linked bill record and the later settled parliamentary record control the current stage. For Therapeutic Goods (Charges) Amendment Bill 2026, readers should distinguish listing, debate, passage, assent and commencement as separate events, and use the cited bill history and explanatory material to check each step.

Common questions

Before you rely on the answer

Does this bill create any new fees for medicines?

No. The bill does not create fees for general medicines. It specifically enables annual charges for grouped biological entries on the ARTG — a narrow category of therapeutic goods derived from living organisms. Standard medicine registration fees are unaffected.

Has this bill passed?

No. As of 5 August 2026, the bill is before the House of Representatives. The second reading was moved on 2 July 2026 and adjourned. It has been referred to a Senate committee, which reports by 1 September 2026.

What happens if the bill does not pass?

If the bill does not pass, the companion Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 could still become law, but the grouped biologicals provisions would operate without a corresponding charging mechanism. The TGA would likely need to use existing charging powers, which may be less suited to grouped entries.

Source spine

Primary material used for this guide

Review trigger: Parliament bill page status changed on 2026-08-13: the bill passed the House of Representatives on 12 August 2026 and was introduced in the Senate the same day (changed_field: status). Review when the Senate Community Affairs Legislation Committee reports (due 1 September 2026), when the Senate passes or amends the bill, upon Royal Assent, or when the official summary changes.

Archive note: This article reviews a proposed bill as at 13 August 2026. The bill passed the House of Representatives on 12 August 2026 and was before the Senate; it had not been enacted. Readers should check the Parliament of Australia website for the current status.

Primary links are provided without affiliate or tracking parameters. Confirm that the source still applies to the bill, sitting date, jurisdiction or reporting period before relying on it.