The short answer

Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026: What it proposes and who it affects

The Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 is a government bill introduced in the House of Representatives on 2 July 2026. It proposes to amend the Therapeutic Goods Act 1989 to: require medicine sponsors to give 12 months' notice of permanent discontinuations; empower the Secretary to demand supply information from all sponsors; allow common biologicals to share single Register entries; move clinical trial site inspection powers from delegated legislation into primary law; and enable the Medicines Watch List to incorporate external documents by reference. The bill is currently before the House of Representatives and must still pass both chambers before becoming law. It was referred to the Senate Community Affairs Legislation Committee on 2 July 2026, with a report due by 1 September 2026. The portfolio is Health, Disability and Ageing.

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 proposes

The Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 (Bill No. 88/26) was introduced in the House of Representatives on 2 July 2026 by the government, under the Health, Disability and Ageing portfolio. It proposes a single schedule of amendments to the Therapeutic Goods Act 1989 covering five distinct public health measures.

The bill would: (1) strengthen the medicines shortages reporting scheme by requiring sponsors to notify the Secretary of any decision to permanently discontinue a reportable medicine at least 12 months in advance, or as soon as practicable after the decision is made; (2) require sponsors who give such notice to update the Secretary if their plans change; (3) empower the Secretary to require all sponsors of approved medicines to provide information about the availability, shortage or discontinuation of their products; (4) enable the Secretary to determine 'common biologicals groups' so similar biologicals can share a single entry on the Australian Register of Therapeutic Goods (ARTG); (5) move clinical trial site inspection powers from delegated legislation into the primary Act, giving authorised persons clear legal power to enter, search and inspect clinical trial sites; and (6) enable the Medicines Watch List instrument to incorporate other documents as in force from time to time.

A companion bill, the Therapeutic Goods (Charges) Amendment Bill 2026, makes associated amendments to the charges framework. The two bills are designed to operate together. As of 5 August 2026, the bill is before the House of Representatives and has not yet passed either chamber. The official summary on the Parliament bill page confirms the bill was introduced with the Therapeutic Goods (Charges) Amendment Bill 2026 and describes it as amending the Therapeutic Goods Act 1989 to expand arrangements relating to medicines shortages and discontinuations, enable the determination of common biological groups, authorise persons to enter, search and inspect clinical trial sites, enable the Medicines Watch List to incorporate other documents as in force from time to time, and make consequential and technical amendments.

Evidence review

The medicines shortages problem

Medicines shortages have been a persistent challenge for Australia's health system. The Therapeutic Goods Administration (TGA) currently operates a Medicines Shortages Reporting System, but the existing framework has gaps. Under current law, sponsors are not always required to give advance notice of permanent discontinuations, and the Secretary's information-gathering powers are limited.

The bill's 12-month notification requirement for permanent discontinuations represents a significant tightening. The EM notes that where a sponsor cannot give 12 months' notice — for example, because a manufacturing problem arises suddenly — they must notify 'as soon as practicable' after the decision is made. Sponsors must also update the Secretary if circumstances change, such as if the discontinuation is no longer planned or the timing shifts.

The new power for the Secretary to demand supply information from all sponsors — not just those who have already reported issues — is designed to give the TGA a more complete picture of medicine availability across the market. This could help identify emerging shortages before they become critical.

Evidence review

Common biologicals groups and regulatory streamlining

Biological medicines — those derived from living organisms — are increasingly important in modern healthcare. The bill proposes to let the Secretary determine 'common biologicals groups', allowing similar biologicals to share a single ARTG entry. According to the EM, this is intended to 'avoid duplication and reduce costs and regulatory burden for industry'.

Rather than each similar biological product needing its own separate registration, they could be grouped, reducing paperwork without compromising safety oversight. This is a deregulatory measure aimed at making the Australian market more attractive for biologicals manufacturers while maintaining TGA oversight.

Evidence review

Clinical trial inspection powers moved to primary legislation

The bill proposes to move the powers for authorised persons to enter, search and inspect clinical trial sites from delegated legislation into the Therapeutic Goods Act itself. The EM states this is to 'confer clear legal power' and ensure that unapproved therapeutic goods used in clinical trials comply with exemption and approval schemes and are safe for participants.

Currently these inspection powers sit in regulations. Moving them into the primary Act gives them greater legal certainty and parliamentary visibility. The EM emphasises this is about ensuring the safety of clinical trial participants — a growing consideration as Australia competes to attract clinical trials.

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Medicines Watch List and other amendments

The Medicines Watch List, made under section 30EJ of the Therapeutic Goods Act, lists medicines for which a shortage would be of critical impact. The bill would allow this instrument to incorporate other documents 'as in force from time to time'. This means the Watch List could reference external clinical guidelines or lists that update automatically, keeping the instrument current without requiring a new legislative instrument each time a referenced document changes.

The bill also makes 'minor consequential and technical amendments, including to improve consistency, remove outdated provisions and correct errors', according to the EM. These are housekeeping measures that accompany the substantive reforms.

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What happens next

The bill passed the House of Representatives on 12 August 2026 without amendment: the second reading was agreed to on 12 August after consideration in the Federation Chamber, and the bill was read a third time the same day. It was introduced and read a first time in the Senate on 12 August 2026, with the second reading moved the same day, and is now before the Senate.

The bill was referred to the Senate Community Affairs Legislation Committee on 2 July 2026, with the committee's report due by 1 September 2026. The companion Charges Bill must also pass for the full framework to operate. Stakeholders in the pharmaceutical industry, healthcare sector and clinical research community may make submissions to the committee inquiry.

Evidence review

Chamber record cross-check — 2 July 2026

The House of Representatives Live Minutes record for 2026-07-02 lists Therapeutic Goods Amendment (Medicines Shortages and Other Measures) 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 Amendment (Medicines Shortages and Other Measures) 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 give the government power to force pharmaceutical companies to keep supplying medicines?

No. The bill requires sponsors to notify the TGA of planned discontinuations — it does not compel them to continue supply. The 12-month notice requirement is about giving the health system time to find alternatives, not about forcing companies to stay in the Australian market.

What is a 'common biologicals group'?

It is a new category the Secretary could create to allow similar biological medicines — for example, different brands of the same type of insulin derived from living organisms — to share a single entry on the Australian Register of Therapeutic Goods. This reduces regulatory duplication and costs.

When would these changes take effect?

Not yet determined. The bill must first pass both the House of Representatives and the Senate, then receive Royal Assent. The commencement table in the bill sets out dates that range from Royal Assent to a date fixed by Proclamation. As of 5 August 2026, the bill is before the House of Representatives and under inquiry by the Senate Community Affairs Legislation Committee.

How does this bill relate to the TGA's existing shortages powers?

The bill builds on the existing Medicines Shortages Reporting Scheme by adding mandatory 12-month notification for discontinuations, broader information-gathering powers, and a more flexible Medicines Watch List. It does not replace the existing scheme — it strengthens it.

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. House Live Minutes and Senate Dynamic Red are consolidated here as point-in-time chamber records; they do not replace the later corrected Hansard or canonical bill 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.