Modernising our digital systems

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.

Moving to a modern, cloud-based platform will improve reliability, reduce downtime, and deliver better overall performance. Additional features and functionality will continue to be added to the live system as part of our commitment to continuous improvement.

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
• strengthen data protection and cybersecurity to support safe, reliable engagement with industry.

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.

We are working towards launching our new TBS system changes in 2026, delivering immediate benefits to all external users.

We are finalising the technical scope based on the feedback during Beta and consulting with industry, including discussions with the Industry Working Group on release timing and how best to support the transition. We will share further detail as planning progresses.

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

From November 2025 to 28 February 2026, a Beta (demonstration) version of the refreshed TGA business services and a prototype of the GMP clearance form was released to gather meaningful feedback from our industry and internal users.

We created targeted and open opportunities for feedback for industry, to assist in refining the product ahead of the full launch. A broad range of industry users connected with the Beta demonstration release through various methods:

• targeted testing with industry representatives through facilitated workshops
• demonstrations at regular industry engagement forums
• open feedback via a public webinar (available for viewing online afterwards)
• online demonstration videos and an online survey.

Feedback from Beta release

Overall feedback on the Beta portal was positive across all forums and engagements, where we heard high satisfaction on the build look and feel and with our engagement approach. The public webinar attracted around 400 attendees, with a satisfaction rating exceeding 85%.

“It was good to have this opportunity for industry users to see the new TGA initiatives outside the smaller working group. This should be the practice when TGA rolls out new initiatives and/or processes.”

- webinar participant

Feedback gathered across all forums reported positive impressions and an improved user experience. 68% of survey respondents indicated they had a positive overall experience and 71% agreed that the new portal is an improvement on the current TGA Business Services system.

Users consistently found the design intuitive and easy to use, with 86% of survey respondents saying the portal was easy to navigate and 92% reporting that logging in was straightforward.

“The idea of the forms library is great. But it needs to be better categorised and laid out so that forms can be found more easily. Also consider renaming it to reflect that this is what would be used to create a new draft.”

- online survey participant

Submission tracking was also viewed favourably with 76% satisfaction from survey respondents, where some noted that more detailed tracking information would further improve usability.

The GMP clearance application form prototype was mostly well received. Users noted the form contained additional questions, but overall reported increased confidence that this would help ensure their application is complete and accurate. It was reported that there are opportunities to find efficiencies in the GMP form by grouping questions, ensuring context is tailored to the users cohort and providing further guidance material.

The feedback also highlighted practical ways to improve the experience for users, including:

• improve naming conventions
• review content grouping and categorisation
• improve filtering of forms by business area
• improve consistency of actions for managing drafts
• improve context and provide more guidance within the GMP clearance application form to improve its ease of use.

We’re now working through the feedback to prioritise and sequence the delivery of enhancements in future releases.

Some enhancements, particularly those related to ‘Forms and Submission’ have already been actioned and will be delivered as part of the release to update the Office of Drug Control (ODC) business service portal in late May 2026.

Work is occurring in parallel on an update to the ODC service.

Because ODC and TGA use the same underlying digital platform, successful changes from ODC can be re-used in the TGA release. This helps deliver benefits sooner and reduces delivery risk.

This re-use of digital components is in line with government digital experience policy and our design approach, building technology once and using many times.

Visit ODC.gov.au for more information

The enhancements being delivered for ODC will flow into the TGA release. For example:

• There will be improvements to naming conventions – among other naming changes “Forms Library” will now be known as “New draft”, as this was providing confusion for many users.
• Filtering functionality across the dashboards will be improved, making it easier to identify relevant forms for your organisation.

Based on the feedback received, search functionality will be strengthened throughout the year and made more intuitive in the TGA service when it is released.

The Beta demonstration videos and webinar are still available for interested users to view, and can be accessed via Learn about our digital platform.

We have co-designed changes to our digital system in partnership with industry and users to ensure feedback and testing directly shaped development.

Throughout the design we have conducted user research at multiple stages and are grateful to those industry members who so generously offered their time to dive into their current workflows and challenges.

Our HPRG Digital Industry Working Group actively collaborates with us to guide product design from an industry user perspective. The Working Group includes a mix of industry representatives, people who use the digital system in their day‑to‑day work, peak bodies and professional associations, and experts with digital, technical, and policy knowledge.

We also work closely with a broad network of internal and external partners to deliver the TGA digital transformation. Engaging regularly with industry bodies, consultative committees and peak bodies both directly and through TGA consultative forums allows us to share updates gather feedback and support readiness.

There will be further rounds of testing and engagement as we continue to rollout.

You can access resources to support you with system changes at Learn about our digital platform, as our rollout progresses. You can watch our recent webinar and videos of the Beta (demonstration) release.

We will continue to share resources here in the lead up to the rollout.

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.