Life Sciences Regulatory Updates for Oceania: 2026

Australia and New Zealand are introducing changes that will significantly impact life sciences companies for 2026. Australia’s reforms include new medicine labelling standards, mandatory adverse event reporting for medical devices by healthcare facilities, and the rollout of an eCTD 4.0 pilot program. Meanwhile, New Zealand’s Rule of Two accelerated approval pathway promises faster market access for medicines already approved by two trusted regulators. These updates reflect a broader trend toward digitalization and efficiency, requiring companies to adapt quickly to maintain compliance and competitiveness.

Australia

Proposed Changes to Labeling of Medicines

Australia’s Therapeutic Goods Administration (TGA) is set to update the labelling requirements for medications following the sunsetting of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) and Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92) in October 2026.

The TGA is proposing new rules with changes that will update the substances and warnings that must be declared, improve label information to keep consumers informed, clarify rules for medicine sponsors and modernize the standards. The proposed changes are still in the consultation phase; however, they will come into effect in the near future.

In anticipation of the upcoming labeling updates, companies should proactively analyze existing packaging against outgoing and proposed standards. Early participation in TGA consultations and being ready with timely update of artwork and packaging will help avoid supply chain bottlenecks.

Reporting of Medical Device Adverse Events by Healthcare Facilities

From 2023 to 2024, only a small proportion of medical device-related adverse events were reported to the TGA from healthcare settings, in comparison to medical devices manufacturers and sponsors, despite healthcare settings usually being the first place that adverse events are observed. Due to this, the TGA is set to implement mandatory reporting requirements for healthcare facilities beginning in March 2026.

CEOs, or equivalent, of healthcare facilities including public and private hospitals, are responsible for reporting adverse effects. Failing to do so will result in civil penalties. Exemptions will be made for facilities not covered under the Therapeutic Goods Act 1989 or the declared facilities in the Private Health Insurance Act 2007. These reports will be managed under the ASDER data stream, which will be used in signal detection to help inform prioritization and investigation processes from IRIS reports.

Because of this update, manufacturers will need to reinforce post-market surveillance systems, align internal processes to analyze facility-generated trends, and conduct staff training to ensure timely response to safety issues, thereby reducing compliance risks.

eCTD 4.0 Pilot

Like many regulators around the globe, the TGA is set to launch a technical pilot of eCTD 4.0 in 2026 for document submission. eCTD 4.0 uses lifecycle management and tracking, along with single submission units and metadata, to improve submission management. Thus far, the TGA has published the eCTD v4.0 AU module 1 and regional information in preparation for the first phase of the technical pilot.

In anticipation of this, companies should begin upgrading publishing platforms to support eCTD v4.0, register for the pilot program by contacting TGA, update SOPs and templates to include structured metadata and lifecycle documentation, and train regulatory teams on new XML and workflow requirements.

New Zealand

Rule of Two Accelerated Medicine Access

The Medicines Amendment Bill, amending the Medicines Act 1981, included a Rule of Two verification pathway for medicine approval in New Zealand. This shortens the verification application of a medicine to 30 days if the product in question has been approved by two recognized overseas regulatory authorities.

This expedited pathway applies to drugs approved in Australia, the United States, Canada, the United Kingdom, the European Union, Singapore and Switzerland. The pathway begins with the drug sponsor submitting the application form, followed by screening based on provided information, evaluation, and then the applicant will be notified of the response. Additionally, the full assessment pathway and the abbreviated assessment pathway remain available.

To prepare for this new approval pathway, companies should review their product portfolios to identify eligible drugs, compile concise dossiers aligned with Medsafe standards, initiate early engagement to confirm eligibility and timelines, and ensure that manufacturing and distribution systems are aligned to support rapid market entry. More information can be found on the official release and on the Medicines Amendment Act.

Where to Start

To navigate these changes successfully, companies must prioritize readiness through strong documentation practices, early engagement with regulators, and process alignment to meet new standards. Implementing an eQMS can significantly support this effort by centralizing document control, automating version management, and ensuring audit-ready compliance records. By combining proactive planning with digital quality systems, organizations can position themselves to take advantage of faster approvals and improved market access in 2026 and beyond. To find out more about how an eQMS can help manage compliance with regulatory updates, and to keep up with other life sciences news, visit our Resource Center.