edicines regulatory agencies face enormous challenges in supporting and maintaining the safety, quality and supply of therapeutic goods in their respective countries and regions. Professor Anthony (Tony) Lawler, head of Australia’s Therapeutic Goods Administration (TGA), took time out from this work to respond to questions regarding the progress that TGA is making on national regulatory and quality issues and his aspirations for the TGA for 2026.

TL: Feedback so far has been positive. The changes we made were based on user testing and feedback, and we reorganized industry information for easier access based on their needs. We added the Product Regulation section, which organizes content by product type, and introduced Business Services for quick TGA Business Service access. The Safety and Shortages section now has clearer pathways for reporting problems and the What’s New feature lists recent website changes in one place.

Reinforcing this positive feedback, in November 2025, we observed a 5% increase in users reporting being “very satisfied” with our website and a 10% rise in users indicating they are “very likely” to revisit compared to the months leading up to the changes. Qualitative feedback has also been positive, including responses such as “Improvements to the website layout are useful and meaningful” and “Fantastic improvement.”

Websites require ongoing maintenance and regular review, and we continue this work behind the scenes to keep the site healthy, secure, and up to date.

RD: The TGA has called for responses to its “Proposed changes to labeling of medicines supplied in Australia,” with the consultation closing on 23 March. What was the rationale for these changes?

TL: The TGA’s labeling orders for prescription and nonprescription medicines, TGOs No. 91 and 92 respectively, will sunset on 1 October 2026. While these are still effective, some areas for improvement have been identified. These include ensuring that the requirements reflect current accepted practice and meet technological and community expectations through, for example, the use of QR codes. New instruments will replace them before they sunset following robust public consultation, incorporating changes where appropriate.

These proposed changes are designed to ensure that medicines are used correctly and safely by healthcare practitioners and consumers, and to provide clearer guidance to sponsors. For example, we are considering separating the guidance for prescription and nonprescription medicines to improve clarity and ease of use. Consistent with sector feedback, we also intend to include more example labels, demonstrating what is and is not acceptable.

RD: TGA has a long history of productive interactions, achievements, and projects with international regulatory agencies such as the US FDA, EMA, NMPA, and PMDA. Congratulations on your recent appointment as Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA), now comprising more than 40 international medicines regulatory agencies including the World Health Organization as an observer. Could you comment on these important relationships?

TL: Our partnerships and initiatives in key international fora and with regulatory counterparts continue to play an ever-important and expanding role in the way we deliver on our work. Fora such as the Access Consortium, the International Medical Devices Regulators Forum, the International Coalition of Medicines Regulatory Authorities and the Pharmaceutical Inspection Co-operation Scheme are key to this work.

These partnerships allow us to use reliance in decision making where appropriate, strengthen post‑market monitoring, align our regulatory approach with global best practice, and support shared initiatives, joint projects, and active collaboration on key regulatory challenges. The TGA has approved 39 new active substances as part of the Access Consortium, including nine orphan products.

The TGA also continues to partner with National Medicines Agencies in countries across the Pacific and South-East Asia to provide technical support and build regulatory capability. Funding from the Australian Department of Foreign Affairs and Trade enables the TGA to deliver the Indo-Pacific Regulatory Strengthening Program in support of this work.

RD: There is a significant global problem of importation of counterfeit products; for example, the TGA website notes that counterfeit melatonin and botulinum toxin (botox) have been identified in Australia. Is this trend increasing? How does TGA monitor this international traffic? It is notable that the melatonin example is backed up by laboratory analyses; would you discuss TGA’s current capability to undertake these and the extent of testing undertaken?

TL: While fewer than 5% of recent referrals from the Australian Border Force (ABF) to the TGA have been assessed as involving counterfeit or falsified therapeutic goods, we do continue to see these imports occurring. The TGA works closely with the ABF to actively monitor for indicators of counterfeit products within Australia and to disrupt any unlawful activity.

The TGA also employs a range of complementary monitoring strategies to support its compliance activities. These programs are both proactive and responsive, drawing on intelligence, signals, and reports of potential noncompliance. These may come from internal sources, external partners, and members of the public.

Testing of potentially falsified or substandard products is a routine component of the TGA’s regulatory activities. Testing is tailored case by case, based on the specific risks identified. Such testing may be initiated in response to safety concerns, alerts from overseas regulators, or other relevant intelligence. Our laboratories can test a range of components from active ingredients to chemical, physical, and microbial contamination.

RD: What are your aspirations for TGA for 2026?

TL: My key goal for the TGA in 2026 is to be a more adaptive, scalable, globally connected regulator. To meet the growing volume and complexity of our work, we need to scale our operations through targeted resourcing and smarter, more efficient processes. This includes responding more quickly while maintaining regulatory integrity.

A major opportunity is the thoughtful integration of AI, supporting both efficiency and quality, helping us triage, analyze and monitor more effectively, and ensuring that our regulatory decisions remain expert-led and transparent.

The TGA must also deepen its global reliance arrangements across pre-market, post-market, Good Manufacturing Practice (GMP) and compliance. Strengthening harmonization allows us to focus our resources where they have the greatest impact.

Finally, a core aspiration is refining our approach to risk. As regulators, we balance risk across the entire product lifecycle, and in 2026 I want us to be clearer about which risks we manage and which risks we consciously accept. One example is our approach to manufacturing inspections, and the extent to which we rely on trusted international regulatory partners within a structured, risk-based framework. This transparency will help us remain both trusted and effective.