June 1st – 5th 2026
Inform Items
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The TGA is hosting a webinar to provide an update on its proposal to share commercially sensitive therapeutic goods data with relevant government agencies on a confidential basis, aimed at strengthening health emergency preparedness and addressing supply chain vulnerabilities.
The webinar is intended for stakeholders who participated in the TGA’s early 2026 public consultation on this proposal, and will cover how the proposal has been refined in response to feedback received. It is co-hosted by the TGA (Department of Health, Disability and Ageing) and the Office of Supply Chain Resilience (Department of Industry, Science and Resources). Register here: Supporting health emergency preparedness and response to supply chain vulnerabilities – proposed release of TGA-held data to government authorities
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The 2026–27 Federal Budget includes $15.8 million to advance national clinical trials reform in Australia, marking a significant milestone in progressing this agenda. The funding will support a six-month ramp-up phase focused on:
- Going to market to select and appoint a delivery partner for the National One Stop Shop (NOSS)
- Developing an accreditation scheme for Human Research Ethics Committees (HRECs)
- Advancing related reform initiatives, including a review of the National Standard Operating Procedures (SOPs)
- Extending the Australian New Zealand Clinical Trials Registry (ANZCTR)
The overall vision and scope of the national clinical trials reform program (including NOSS) remain unchanged.
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UDI Update – The TGA has released their May 2026 UDI Newsletter, covering several updates across guidance, database resources, and fees.
The UDI timeframes guidance has been refreshed with additional examples, clearer transitional arrangements, and improved guidance on ‘sponsor control’ for existing and consignment devices. A set of new AusUDID pages has also been added to the TGA’s UDI Hub, consolidating practical resources on data elements, access, roles and responsibilities, submission methods, and troubleshooting.
From 1 July 2026, a streamlined UDI Consent to Supply (CtS) process and revised fee structure will take effect — $80 for the first ARTG entry and $10 for each additional entry. These reduced fees apply to applications submitted on or after 1 July; no refunds will be issued for fees paid before this date.
Sponsors are also reminded that certain AusUDID data elements are conditionally mandatory depending on other data provided. Full details are available in the Australian UDI Data Dictionary.
Finally, the UDI team will be rolling out a system update to the AusUDID across two windows — Pre-Production on Tuesday 9 June (5:00–9:15pm AEST) and Production on Thursday 11 June (5:00–9:15pm AEST). The update includes an enhanced search function, improved download experience, a new ‘Manage Data’ tab, updated bulk upload and NPC submission channels, and improved TGA synchronisation. Release notes will be published on the afternoon of 9 June.
Action Items
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The TGA is seeking targeted feedback on proposed additions to its UDI audit selection guidance, specifically around how UDI requirements will be applied to new Class IIb and Class III device applications from 1 July 2026. Members are encouraged to submit comments via the RegConnect consultation page by COB Tuesday 9 June to be incorporated into MTAA’s response.
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The IMDRF has opened public consultation on its draft Technical Framework for Artificial Intelligence Life Cycle Management (Document N93). Members with feedback are encouraged to share input via RegConnect by 3 July.
- The IMDRF Quality Management Systems Working Group is seeking feedback on its draft Guidance on the Control of Products and Services Obtained from Suppliers, ahead of finalisation for publication. Members are encouraged to share views by 29 June.
Have a lovely long weekend everyone!
