To see the Beta demonstration videos and have your say, go to Learn about our digital platform.
About the transformation
Our goal is to create a flexible, transparent, and connected regulatory platform that strengthens our ability to protect the health and safety of all Australians.
We’re replacing outdated, hard-to-use systems with new digital tools to improve your experiences, streamline your interactions with us and make it easier for you to meet your regulatory obligations.
These new systems will be more reliable, stable, and easier to adapt to our evolving operating environment.
Through a cycle of ongoing improvement, we will continuously assess, review and build on these systems to ensure they are fit for purpose and meet industry needs into the future.
Our new services are being designed with the user at the centre, are cloud-based and comply with the Australian Government digital policies and user experience standards.
What we are improving
We are introducing a modern system that includes a new Health Business Services portal for single sign in, refreshed TGA business services, smarter case management, and improved data handling. We are aiming for the new system to be available from mid to late 2026, following the release of a Beta demonstration version for feedback in November 2025. Additional features and functionality will continue to be added to the live system as part of our commitment to continuous improvement.
Moving to a modern, cloud-based platform will improve reliability, reduce downtime, and deliver better overall performance
We are also updating our internal business processes to work alongside the improved digital platform.
Through this transformation we aim to:
- reduce regulatory burden
- respond more effectively to the needs of industry, patients, consumers and healthcare professionals
- make faster, more efficient and consistent decisions
- provide more accurate information to health consumers
- lower risks to government service delivery.
A refreshed TGA business services portal
We are introducing a single, digital front door for health industry.
This approach provides users with a single, secure, authenticated access point to manage business with us through the Health Business Services portal.
Users will login to the Health Business Services portal and choose the relevant area they need to engage with (for example, TGA or ODC).
Selecting the TGA service tile directs to the modern TGA services replacing TGA Business Services (TBS).
The new portal will make interactions with the TGA simpler and more efficient, and includes:
- a streamlined login process for faster, easier access
- improved navigation and a redesigned landing page with user-friendly layouts to help you quickly find the functions you need
- a dashboard personalised to you, your forms and submissions
- a new forms library with better search functions and bookmarking for frequently used forms
- a My Submissions section where you can view all submissions lodged with us
- a new dashboard with real-time submission tracking and filters for quick information access.
Smarter case management
We are working behind the scenes to improve the staff experience in case management, which will improve workflow and productivity. We’re exploring opportunities to integrate artificial intelligence (AI) safely and ensure more accurate data processing.
This will:
- enable faster processing of applications
- provide clearer updates of progress to industry
- provide more adaptability to changing regulatory and policy landscapes
- process better more accurate data, supporting better visibility in the portal for industry.
Better data, better decisions
We’re improving how we manage and share data across relevant areas. This includes enhancements to how we collect, store, and use information - supporting faster, more accurate decision-making.
Our goal is to collect your information once and reuse it across systems. This reduces duplication, saves time, and ensures our systems are ready for AI-powered capabilities.
Timeline
We are launching our new system changes in mid to late 2026, delivering immediate benefits to all external users.
Industry can start using the enhanced portal as soon as it goes live and can access:
- the portal
- all your current forms.
Existing forms will be uplifted and improved over time. Ahead of any future launches, we will communicate extensively and undertake further testing rounds to ensure products are sufficiently tailored.
The uplift of existing forms will start with Good Manufacturing Practice (GMP) clearances. We are starting with the services and processes that support our manufacturing evidence management functions, as they are used by around 75% of our sponsors/agents and underpin most of the processes they rely on.
This includes GMP clearances, certificates and licenses, device conformity assessments and device manufacturer evidence.
Beta release: November 2025 to February 2026
A Beta (demonstration) version of the refreshed TGA business services and a prototype of the GMP clearance form was released in November 2025 to gather meaningful feedback from our industry and internal users. The beta period runs for three months (November–February).
There will be targeted and open opportunities for feedback to assist in refining the product ahead of the full launch.
This information will be collected by:
- conducting targeted testing with industry partners through workshops and engagements to refine the product ahead of the full launch.
- seeking open feedback via public webinar and demonstration videos.
Access our video resources and have your say in the accompanying survey at Learn about our digital platform.
Who we work with
We have co-designed changes to our digital system in partnership with industry and users to ensure feedback and testing directly shaped development.
Our HPRG Digital Industry Working Group actively collaborates with us to guide product design from an industry user perspective.
There will be further rounds of testing and engagement as we continue to rollout.
Resources
You can access resources to support you with system changes at Learn about our digital platform, as our rollout progresses. At this page, you can watch our recent webinar, see videos of the Beta (demonstration) release and access a survey to have your say.
Contact
If you would like to be part of future testing and feedback, please sign up to our user research group at Join our user research group.
If you would like to join our mailing list for regular program updates, or have any further questions please contact our team at TGADigitalStakeholders@health.gov.au.