TGA Digital Transformation - Exploring the Beta version of the new TGA business services portal

Speaker Key:

• TL     Professor Tony Lawler
• CB    Chris Bedford
• CT    Cindy Toms
• AM  Alysha Martens
• MD  Michael Davis
• LT    Lisa Tepper
• JF    Jennifer Frisby

00:00:00

CT              Thank you and good afternoon, everyone. So as mentioned, I am the Assistant Secretary of the Digital Branch, and I will be your host for today. And the purpose of today’s webinar is to share with you our beta release and seek your feedback as well as answer any questions that you may have. 

                   So we will be with you for about 90 minutes, starting with an introduction from our Deputy Secretary, Professor Tony Lawler, followed by a walkthrough of the beta, which is a demo version of the new TGA portal, and this portal will replace T-Biz. 

                   So the demo will be led by Alysha Martens and Michael Davis. Following this demo, I will invite Chris Bedford, Lisa Tepper and Jennifer Frisby to join the speakers in a panel format for question-and-answer session at the end. So please drop your questions into the Slido as we go through the presentation. 

00:00:50

                   And thank you to those who’ve already pre-submitted questions as part of registering for the webinar. We will respond to as many as we can in the Q&A. And anything we don’t get to or have to take on notice, we will make sure we publish and provide those to you after the webinar. 

                   So the webinar is part of our engagement and feedback strategy for the beta release. So I want to welcome you all officially to beta testing and thank you for your time today, as your feedback is really critical to how we shape the future digital experience. 

                   Our testing period commenced in November, so we’re a couple of weeks into it now, and will run through to February 2026. This is a really important milestone for this work, and subject to the beta testing, we’re hoping to have a production version of the new TGA portal available in mid- to late 2026. 

                   So there will be a few different ways to engage and explore the beta release. Obviously, this webinar is one, which you’re all in now. We will also publish the webinar on the TGA website for anyone who’s not able to attend today or if you would like to re-watch it. 

00:01:55

                   We are conducting facilitated user research sessions. These are small group testing sessions with industry representatives from our industry working group as well as other key organisations. And during these sessions, those participants will be able to log in using a test account that is created for them, and then guided through the portal to explore its functionality. 

                   In those sessions, we are engaging about 45 to 50 people, including 15 people who don’t currently use the T-Biz portal. It’s really important we get feedback from both experienced users but also from users that aren’t as familiar with the system because it’s those users that really help us design how intuitive the system is. 

                   We are enabling some small group sessions for experienced users. And this will be independent run-throughs. They’ll be able to log in and explore the portal by themselves. But due to security requirements, we do have to limit this option to just that small group of users. But for those not involved in the targeted testing, there is still plenty of ways to get involved and provide your feedback. 

                   We’ll be releasing demonstration videos on the TGA website on 16th December. These videos will walk you through the new portal, from logging into it to each of the different areas which Alysha will demonstrate today and showcase the functionalities of the new system. The videos will also be published on the behind-the-scenes case management system and a proposed new GMP Clearance form that we encourage you to provide feedback on as well. 

00:03:28

                   So there’ll be many opportunities and surveys to fill out, including one today. So please do fill them out as you go along. It’s really important that we capture your thoughts. And grateful for the time that you spend with us in providing this feedback. 

                   The feedback today actually has been quite positive. We’ve been doing beta demonstrations with our regular industry engagements. And thank you to those that have already participated so far and provided us some really helpful feedback, which we can action. And with that, I will hand over to Tony to say a few words. 

TL               Thanks very much, Cindy. I’m excited, along with the rest of the team, to be here today to share with you our most recent work on digital transformation. So it’s really worth recognising that this is a milestone moment for the TGA. As you’re all aware, our current digital systems are ageing and not as flexible as they need to be. And this means that we can’t support industry needs, a changing regulatory environment or, indeed, our own staff in a sufficiently agile way. 

                   So the team has been working on building new digital solutions and have been engaging with industry to shape and inform that build as we go. Thank you to everyone who’s attended testing sessions and provided feedback over the last few years. The changes that they made to the design that you’ll see today have been heavily influenced by industry feedback as well as feedback from our internal business partners. 

00:04:53

                   What we have designed and are showing today are testament to the work and effort from you all. And we look forward to a more stable, usable and efficient system for both our staff and our users. 

                   Now, I know you’re eager to see the demonstration, but I do want to take a moment to share some of the thinking that’s gone into building these new systems. As we transform the TGA’s digital systems, we ensure that we’re designing systems that we can build once and reuse across multiple services and business processes. Improving our data management processes and changing how information can be shared across all relevant areas has been a priority for us. 

                   Our goal has been to collect information that is provided to us once and to use it across our systems. This approach saves users time, reduces duplication and ensures our systems are AI ready. We’re also working behind the scenes to improve the staff experience in case management, which will improve workflow, productivity and efficiency. 

                   So the team will talk through the benefits of the systems they’re demonstrating in a few moments. So I just want to say that this is a huge step forward in our transformation journey. And I really encourage you all to continue to actively participate in the beta testing and continue to shape our final products and systems. So I’ll now hand over to Alysha Martens, who will talk us through the beta release and demonstrate it for us. 

00:06:12

AM             Thanks very much, Tony. And good afternoon, everybody. So I just wanted to share with you a little bit of history on some of the current state challenges, because what you’ll see shortly in the demo is only a small piece of a much bigger solution that we’ve been working towards. So I wanted to share some of this with you today, as it is often the side of digital uplifts that is most difficult to demonstrate, as much of it sits behind the scenes, but it’s where a lot of the heavy lifting actually takes place. 

                   So as you can see here, there’s multiple initiatives been stood up over the years in an attempt to provide improvements to the experience of both internal and external stakeholders interacting with these systems. These initiatives did not always take into consideration the broader TGA digital landscape and sometimes created bigger problems than the ones they were designed to solve. 

                   So in recognition of this and the need to ensure digital solutions address the right problems and continue to remain fit for purpose as business needs and technical landscapes change, this led to the establishment of the HPR Digital Branch, so many of us that are talking to you today, including Cindy that provided the introduction. This was established in 2023. 

                   So this branch is responsible for ensuring TGA’s digital solutions are fit for purpose and continue to remain fit for purpose as they evolve with changing business needs and technical landscapes. This branch is made up of dedicated digital professionals that continuously assess TGA’s digital landscape and support the development of initiatives that solve the right problems and integrate effectively with the existing landscape. 

00:07:43

                   So while it’s nice to have a modern design interface like the one you will see in the demo soon, we have heard you, through our industry consultations and working groups, that what you really need is for our systems to be reliable so you can complete your tasks without system disruptions. 

                   So alongside providing more designs and user-friendly digital solutions, a lot of the heavy lifting we’re working through is behind the scenes to ensure what you’re interacting with is reliable and allows you to complete the task that you need to complete. 

                   So I’ll just run through a bit of a snapshot of the current state, which I’m sure many of you are familiar with, but some maybe not so much. So what you can see here is some screenshots of the existing system, including the login page, which currently uses a username and password, and you have one login per each organisation. 

                   And there’s often a need to go to sub-portals to progress work with TGA. What we’ve also heard, and is demonstrated by the previous view, was it’s often unreliable and has system outages. So you can see that in one of the quotes captured there. 

00:08:51

                   Just moving along, I guess, to some of the other screenshots that I wanted to share, additionally what we heard from feedback from industry was that the current system designs are unintuitive to navigate, with inconsistent navigation and different views appearing in one typical end-to-end user journey, making it confusing to know if you’ve navigated to the right place, creating quite a fragmented experience. 

                   So with that, this leads us to some of the products which we’ll be demonstrating today, and I just wanted to give a bit of a recap on what these are. So this beta release is an opportunity for us to demonstrate value and progress, both to industry and internal staff, and give all of our stakeholders an opportunity to help inform the future products prior to the live launch. 

                   So where are we at? We had some excellent milestones met for the website. So we updated the information architecture on the website, which was released in the beginning of November. So that improved the structure of the website and how users can access information, and then improvements through grouping similar information together. So if you haven’t already, please go have a look at the website, which is live. 

                   And then the beta components, which we’ll be demonstrating today. So there’s obviously an external facing component of it, which is the new Business Services portal, or what you might know and use today as T-Biz, and then including a prototype of the new GMP Clearance form. 

00:10:18

                   We’ve also got our internal facing component, which my colleague, Michael, on the call will share as part of the demo. So this is our new case management system that supports our staff through better workflow applications received externally. And we’ll provide a brief demonstration of this shortly so you can see how it interacts with what you’ll see on the external facing portal. 

                   Just a quick highlight on some of the features we’ll be looking to go through today on the external facing portal. So where we’ll start the journey in the demo is a departmental-wide front door to help industry access Business Services not only for TGA but across the department. 

                   Improved navigation, so reducing the number of clicks to get to where you need to go. Ability to bookmark frequently accessed forms and applications. Greater visibility on submission progress, where things are up to in our processes. And, of course, improved system reliability. So with that, I will start the demo. 

                   All righty. So where we are now, I’ve just gone through the steps of logging in. For the purposes of this demo, I’ve skipped that step, because it’s just using a demo login account. But where I’ll land is the Health Business Services portal home page, which gives me an option to sign in or register. I’ve hit sign in, entered my credentials for the purpose of the demo today and, once authenticated, has landed me here, which is the Health Business Services landing page, which gives me access to the relevant services across the department. 

00:11:59

                   So I won’t talk too much about the other services that are here today. So you can see Office of Drug Control, Tobacco Control and, of course, the Therapeutic Goods Administration service tile. So for the purposes of this demo, we’re just going to be focussing on this service tile here. 

                   So on clicking view service, this will take me to the TGA landing page. So this is what the updated TGA Business Services, or T-Biz, might look like, and this is what we’ve been taking to our facilitated beta sessions, which have already gotten some excellent feedback, as Cindy mentioned. 

                   So what you can see here is more easy navigation to get to where you need to go. So we’ve got the nav menu down the left here, which provides the relevant access to all the existing functionality you can access today in T-Biz, just in a more intuitive manner, and we’ve also got the tiles view. So everything that you can see here today is supported, and web content accessibility meets all the web content accessibility standards and, we’re hoping, provides a more intuitive user experience. 

                   So where I’m going to start my journey today is through the forms library. So if I were to be looking for a service application or form to complete with the TGA, this is where I’d typically start my journey. So on clicking here, this will land me into this screen. So what’s different about this from the current state is we often heard from industry users it’s quite tricky to find what you’re looking for, and there’s some services that are captured in T-Biz, some on the website, some in other sources. 

00:13:37

                   So what’s different about this page is we’re ensuring that all of the different forms that we provide at TGA can be accessed from a consolidated place, which is the forms library. Additionally, this has better search and functionality to filter certain results. So if a lot of the forms here aren’t relevant to you, you can find the more targeted forms that are more relevant to your day-to-day business. 

                   This can also be toggled to a list view, so you have ease of access to be able to go through in a little bit more ease, rather than the tile view, depending on your preference. One additional feature that is quite different to the existing system is this bookmark tab. So if I come to the T-Biz portal to complete the same forms maybe multiple times, I can bookmark these for ease of access. 

                   So for the purpose of this demonstration, we’ll be using the GMP Clearance application form as an example, because this demonstrates the new portal form technology that we’re looking to implement and roll out across all the different services. 

                   So just to reiterate that with the forms library, you will still be able to access all the services that you can today in T-Biz and in various other sources. They’ll still be made available. But we’ll be incrementally updating each of those forms so they start looking like what you might see here today in the demo. 

                   So I’ve clicked the GMP Clearance application form, and this takes me now to what we’re calling a twilight page. And this page gives me enough detail to help me to support starting the application, ensuring that it’s the right application for me. 

00:15:14

                   So it tells me key details that I might need to have handy to support me in completing this application. It tells me how much it costs to complete the application. And it also provides me handy links to any guidance or supporting material that I might use in reference when I’m completing this application. 

                   So I’ve clicked start, and this has landed me to the portal form. And what’s different about this portal form, besides just the look and feel because it’s quite different to the ones that you might see at the moment in the existing T-Biz portal, but also the way the form is set up in its navigation. 

                   So from the left hand panel here, you can see the relevant sections that are left to complete for each of the parts of the form. So it’s a little bit more intuitive on sections remaining and what’s to come next. It also includes more intuitive lookups and ease of reference, so if there’s things that you would normally need to type in or provide from other places. As Tony was mentioning, we’re looking that you tell us once to reuse many times. Where we can apply lookups that are relevant, we’ll do so to reduce that duplicate of entry. 

                   So if I’ve gone through, completed all the mandatory fields for this application and hit submit, I then would expect to see this in the submission dashboard. So this dashboard is quite different to what you might see in T-Biz today. The initial layout has some of the similar columns that you would see, but we’re looking to provide more information in this view than you would otherwise get in the existing T-Biz dashboard. 

00:16:49

                   So in this view, an important one for us was to include a workflow step. So this is more detail around where things are up to in our processes. So if I click on the example for today’s demonstration, this will take me to a page that looks like this. 

                   Now, this page provides a progress tracker, which then details the different steps that the application or submission is up to in our internal facing processes. So we’ve heard that from various industry working groups, from the various beta and alpha testing and concept testing we’ve done with industry. And this was one of the big pieces that we knew we had to get right to support industry outcomes. 

                   So what Michael will demonstrate in a moment is how this view is translated in our internal facing systems, because each of these steps here are configurable, so they’re more meaningful to each of the application types that are presented as part of the portal. 

                   And obviously, for this demo, it’s just demonstration data, so some of these are pretty generic, but we’re able to customise these to make them compatible or relevant to each of the different submission types. So I might just pause there and pass over to Michael, who will be providing a demo of the internal facing system. 

MD             Thanks, Alysha. So the screen that I am showing now is the other side of the coin that Paul or that Alysha was just demonstrating. So this is our internal case management system, and there’s a few things that I’d like to call out here. At the top, we can see the workflow step that this case is at. 

00:18:39

                   So it is under assessment in the assessment case stage, and our clock is running. We’ve got a target processing time frame listed up here, with 29 days left in it, and those workflow steps that Alysha was demonstrating, the train tracks in the portal, they are showing up here in the workflow steps for our case. So as Alysha noted, they’re very generic. I would expect these to be customised for our GMP Clearance application form when we do move into a production state. 

                   But at this point in time, our milestones that will be showing up in our portal are application submitted, payment received, assessment completed and outcome notice issued, with start and end dates for each of them. These workflow steps allow us to provide a lot more transparency back into the portal than what is currently the case, and importantly, these workflow steps are all based upon configuration data. 

                   So pretty much everything that creates our case, so all of the elements that come together and make this case, are configurable, which means that should the TGA’s regulatory posture, its legislation or its structure change over time, we’re going to be able to update the data that sits behind our cases, to make sure that they remain relevant. 

                   That means that the enhanced transparency that we provide back into the portal is going to be reflected by… Maintained by keeping it in sync with the actual way that we process our cases. So here you can see the active workflow steps that I’ve got for this particular case type. 

00:20:15

                   If we needed to add to this list or detract from it, should we change the way that we process our cases, we can do so. This is probably the biggest difference between our current case management system and the future state that we’re moving towards, so this ability to flex over time to actually continuously align with the status of our actual delivery. I might pause there and hand over to Cindy and see if there’s anything that anyone wants to delve into deeper. 

CT              Thank you, Michael and Alysha. And we do have a couple of questions that I think we can stay in demo mode for, because you can potentially show the answer as well. But the first question is, will my drafts or my submissions include all submissions and drafts for my organisation? 

AM             Thank you, Cindy, and thank you, Sara, for asking that question. Oh, and excellent, Michael’s got that up on the screen. So if you just go back to the submissions dashboard, Michael, essentially this dashboard view will include a consolidated view of all submissions across the organisation. So unlike T-Biz, there are some, of course… I’ll share my screen. It’s all good. Here we go. Beautiful. 

                   So unlike the existing system, sometimes there’s sub-portals. So you’ll find that if you’re looking for certain activities, you might feel like you’re going through a different user journey to find the same information that should theoretically be sitting in one dashboard. 

00:22:10

                   So what we’re looking at here is consolidating any submissions that come from sub-portals, as sometimes they’re referred to, to be displayed in one view. And this will be the same for drafts as well. Are you happy for me to keep going through the questions, Cindy, or did you want to read a couple out in particular? 

CT              Yes, I think we’ll just go to the next one that’s been upvoted. So will we receive milestone letters and other correspondence in the My Message tab once the new portal goes live, instead of via email? 

AM             That’s a great question. So the messages functionality we haven’t included in this beta round because it is still in concept testing. So we did some early concept testing with industry, probably about six months ago, on the messages functionality. And that will be the next deliverable that we take through to beta after this one. 

                   So we haven’t worked out all of the details that will be supported for the messages tab. But certainly, the intent is that any correspondence relating to submissions or even more generally will occur through the portal instead of via email, and that there’ll be ability to be notified that there’s something in the portal for you to action or respond to. And this might be an email notification or something like that, that will just let you know that there’s something to action in the portal itself. But more work hopefully on that in the months to come. 

00:23:42

CT              All right. Thanks, Alysha. We might just go to the next one. And I think this is you again. Will all the online forms follow the same format and have the same functionality in the new portal? There is no consistency at the moment across those forms. 

AM             Yes, that’s an excellent question. Thanks, Ron. The biggest pain point we’ve heard is that the current system feels very fragmented. So you might go down a particular pathway to complete a form and feel like you’re in a completely new environment, with a new look and feel and design. 

                   So we’re working on, at the moment, at a minimum, ensuring all forms have the same design elements as the form that I just demonstrated before for GMP Clearance application, and then incrementally, over time, move them all onto the new technology so that they’ll have that same format that you could see as part of that GMP Clearance application. 

                   So priority one will certainly be to make everything feel more consistent. And then priority two will be looking at how we can support more transformations of those processes and fit them into that model that you saw for the GMP Clearance form with the new technology. 

CT              Thanks, Alysha. I have one for Michael. So re. the tracking application progress page, can you add a checkpoint between payment received and review completed, for example, assessment started or expected completion? 

00:25:12

MD             Thanks, Cindy. The great thing about the way our milestones work is that they are completely configurable. So the desired end state will be a combination of our internal users’ needs and the transparency that we need to provide back to the portal. So as we work with our internal business areas to transform their processes and get them into this new system, we will be setting up those milestones. 

CT              Thank you, Michael. A question from Cecile. Will it work on all internet browsers? 

AM             Yes, it will. 

CT              Great. We have, if I am halfway through filling out an application, how do I navigate back to the page of helpful links that supports the application process? Maybe, Alysha, this one’s for you. 

AM             Yes, that’s a really good question. So I think, as demonstrated here, if I am in a particular application, I can also have this tab open with the form summary. So it helps me to navigate back to the page of helpful links that supports the process while I’m completing the application at hand. And I think you can also bookmark some of these if they’re particular guidance that you use all the time, but they’ll be here for reference in a tab as you click through to start the application. 

CT              Okay. Will draft applications in the old system transfer across to the new system? 

AM             I think this is a great question, because this is actually a demonstration of some of the behind-the-scenes, all the hard work that we’ve been doing to improve reliability and consolidation that’s sometimes tricky to capture in a short demo. But yes, the intent is that all draft applications in the existing system will absolutely transfer across to the new, and then be accessible from the new T-Biz portal, yes. 

00:27:24

CT              Thanks, Alysha. Now one from Kelly. Will the user workflow show the clock of the elapsed time versus target time frame, or is this only for the internal side? Now, I’m happy to take that one. So we are working on this functionality. At the moment, in the beta, it is only on the internal side, but we are exploring how we might be able to display that across TGA on the external side, and checking if it’s technically feasible and making sure it works for the whole business. 

                   So I think one more for the demo, and then we might move into a more formal Q&A unless anyone wants to quickly upvote another demo question. But will my completed applications sit in the submissions tab repository, which can be retrieved at a later date? 

AM             Yes, I’m happy to take that one. So I think from my understanding of the question, I guess we’re referring to this submission dashboard, where all of the completed applications, a record of them is sitting there. And yes, we’re looking at ensuring that this captures a consolidated view of all submissions for the organisation, and that you can filter these by relevant times they were submitted. So if you’ve got older ones that have been sitting there for quite some time, you can go and retrieve those relatively easily. Yes, the intent is that they’ll all be sitting here. 

00:29:09

CT              Okay. I think there’s still a few more questions coming through, but what we might do is, we’ve got plenty of time, we might just move to the more formal Q&A type question. And as those questions come through, we’ll continue to promote them through to the Slido. So just a reminder to fill out the survey when you can. Maybe even if you’re watching now and want to start filling out the survey, that would be great, if not shortly thereafter. 

                   But time for some questions, and thanks so much for your engagement so far. It’s sometimes hard to keep up with your questions as they move on the screen. But I would like to welcome Chris Bedford, Lisa Tepper and Jennifer Frisby to the panel. Chris is the head of the Regulatory Practice and Support Division, and Lisa and Jen join us from the Information Technology Division. 

                   As I said at the start, thank you to everyone who submitted some questions at the time of registration. That was very helpful, and we’ve tried to answer many of them in the session today. But we’ll start with some of those today, and then continue to work through those Slido questions. And as I said, anything that we don’t get to today, we will definitely make sure that we circulate answers to after this webinar. 

                   So the first question, and might have actually been answered already in the demo, so go to the next one. What services will be provided in the new system, and when? So, Chris, would you like to answer this one? 

CB              Yes, I’m happy to answer that, Cindy. Good afternoon, everyone. So, look, I think Lisa and Michael have gone through a lot of the services. But just to recap, there’ll be these immediate benefits for our external users when we go live in mid- to late 2026. 

00:31:10

                   Everything TGA stakeholders need to do will be able to be accessed through that new portal. So when we go live, you’ll be able to access all the forms, both new and old. And we’ve talked about them having the same look and feel, even though there’ll be a different technology there. The dashboard that you’ve seen will be available to use. Payments will be able to be made through that front door too. And then over time, we’ll start shifting the forms to the new technology too. 

CT              Great. Thank you, Chris. The next question is, I’m an agent. I represent many organisations and have many logins. What will this look like for me in the future? Jen Frisby, would you like to take that one? 

JF               Sure. Can I just check that everyone can hear me? Because I am having some microphone issues. There we go. So Jennifer Frisby. I look after health business systems in the department. So if you’re an agent, when you sign into the Health Business Services portal, you will register with one login, which will allow you to access all your existing T-Biz accounts. 

                   Agents who have multiple logins will only need one HBSP logon moving forward. So if you’re an agent and you work for multiple organisations, when you access the new T-Biz, you’ll see a list of organisations you represent, and you’ll be able to choose the organisation you’re representing for that particular session. 

00:32:41

CT              Thank you, Jen. 

JF               Thanks, Cindy. 

CT              Okay, next question. What support will there be for go-live of the new system? Alysha. 

AM             Thanks, Cindy. So this is actually one of the many communication and industry consultation mechanisms that we will do for go-live. So we heard from industry that doing something like a beta and being able to work with or recognise and play with the existing system and see how it’s set up, sorry, the new system alongside still using the existing system, was appreciated, because it meant that the transition could happen slowly and you’re not forced to use the new product day one without having experienced what it looks like. 

                   So that is part of us doing beta testing, and like these webinars today. But also, we’ve got many different working groups that we have at TGA, including a broader industry working group, where we provide communications on upcoming features that we’re working on and getting more general feedback. But there’ll be a range of things that we’ll do for go-live, including demonstrations like today, and the ones that Cindy mentioned will be uploaded onto the TGA website.

                   We’ll have communications throughout, including newsletters and email communications as necessary, engagements like this one, and then hands-on training and support through also quick reference guides and documentation to support you in navigating the new systems. But yes, we’ll be holding many more sessions to deep dive before we go live next year. 

00:34:27

CT              Thanks, Alysha. I think the next one might be for you as well. Will the new e-Biz platform impact the information that is included on the ARTG record? 

AM             Yes, sure. So there is no direct impact on the ARTG from the current planned go-live. So we understand there are challenges with how the ARTG represents information to the public, and we’re concurrently working on that to improve some of those mechanisms. But the work that you’re seeing today, it has no direct impact on the structure of the ARTG as you know it. We’re just looking at usability improvements on how we can display that information a little bit better. 

CT              Thank you. The next question is one for Lisa Tepper. Is the system cloud-based, and which security measures are implemented? 

LT               Thanks, Cindy. Hi, everybody. I’m Lisa Tepper. I look after Information Technology in the department. Yes, the system is cloud-based. It’ll be hosted in one of our sovereign cloud environments, and it will comply with all federal government cybersecurity requirements. The department has a low risk tolerance for anything that might compromise cybersecurity, IT services, or secure and legal data sharing. So it’ll be IRAP assessed and all things it needs to be. 

00:35:49

CT              Great. Thank you, Lisa. Will there be changes to timelines and submission processes? I might see if Chris can answer this one, please. 

CB              Thanks, Cindy. Look, I’m taking this as seeking efficiencies in the regulatory timeframes as opposed to a full change to the submission process, which is out of scope. Although, no, as we’re looking at how we transform the TGA, we look at if there are any business process efficiencies we get out of part of that transformation. But look, absolutely, the enhancements to the case management system aim to improve our workflows, productivity for our staff and transparency for everyone. 

                   So while the timelines and submission processes are not subject to change as part of this scope of work, we expect that the internal improvements will enable faster processing of the applications. It’ll provide clearer updates to industry, provide more adaptability to change regulatory and policy landscapes and deliver better and more accurate data. And it will support better visibility in the portal as well. Thanks, Cindy. 

CT              Thank you, Chris. Now, this next one, I think, will be for Tony. So we have received two questions from representatives on the Medicines Australia’s Regulatory Affairs Working Group, or RAWG. Part of the question goes to how will TGA be transitioning away from legacy systems? And the next part is, what is TGA’s approach to adopting AI? And for both of those, will industry be consulted? 

TL               Thanks, Cindy. I’ll answer the last question first. And the answer is yes, we take very seriously our stakeholder engagement responsibilities. I was going to say obligations, but they’re responsibilities, because not only do they lead to a better experience for industry and stakeholders, but they lead to us developing a better regulatory product, I guess, for want of a better term. 

00:38:00

                   So we’ve had a really strong focus this year on the website and the portal, because we see that they are the innovations that are going to provide the greatest lift and experience for industry and for users and also for staff, because it means that industry is going to be able to access the information they need and to access an improved, modern and flexible T-Biz. And it’s our hope that all of industry is going to get value immediately through the use of our service layer. 

                   And at the same time as doing that, we’re working behind the scenes to map out the technical steps we’re going to need to move data from our legacy systems, like Lotus Notes, over to a cloud-based platform, which we’re going to need to support further transformation, our readiness for AI innovation, and also to address some of the underlying data issues that are related to the ARTG. 

                   But it’s important to note that in addition to stakeholder engagement, business continuity is absolutely key. We recognise the importance of that, not only for industry and for our staff, but also for the regulation of therapeutic goods for safety and quality for the Australian public. So it won’t be interrupted, and it’s important to note, I think, that systems like Lotus Notes will remain supported until the time they’re ready to be decommissioned. 

00:39:15

                   In terms of AI, I think it’s important to note that here at the TGA, we look at AI within the departmental context through four lenses. One is how can AI be best leveraged to provide better care for Australians? Secondly, how do we regulate it as a therapeutic good? 

                   Thirdly, we are well aware, and a lot of the feedback that we have from the floor [?] is really informing our conversations here, we’re aware that industry sponsors and manufacturers are using AI to make their processes more streamlined. And so, fourthly, how are we going to use AI in our own processes to make them more streamlined and more responsive and more efficient? 

                   So we’re undertaking a lot of work to explore how the safe and effective use of AI, alongside improved data collection and data methodologies and sharing, could lead to reduced evaluation times. 

                   And we’ve done quite a bit of work with the policy development unit and the strategic policy area within the department to look at how AI can be used in our evaluation times, particularly where we’re looking at the evaluation and reliance on obviously [?] regulated decisions, but also how AI can be used in improving our compliance activities and increase our productivity, which will all, we believe, contribute to getting therapeutic goods to Australians faster and improving the level of confidence they can have that those therapeutic goods are safe and effective and efficient. 

                   We’re also obviously exploring how we can most effectively use AI to improve our own business processes and productivity with improvements to our data assets behind the scenes, making it more efficient and accessible. 

00:40:57

                   And, yes, as I started, I’ll finish. We’re going to continue to engage with industry as we progress this digital transformation because we firmly believe that if we don’t have a system that works for industry as well as our own staff, then the system’s not going to work for anyone. 

CT              Great. Thank you, Tony. The next couple of questions are probably more Michael and Alysha. So the first one, I think, for Michael. Is there any update in submitting larger size files? Currently, it’s capped at 100 MB. If more than that, we have to use TGA’s SharePoint drive. 

MD             I’ll take that one. Thanks, Cindy. So this is a well-known current pain point with our existing system, one that’s thoroughly on our radar. And we’re exploring options for how we address it, both in our existing build and looking at the way we could roll out, for example, third-party services like LORENZ docuBridge.

                   So you can rest assured that it is something that we’re focussing on. In the context of our GMP Clearance application, we’re looking holistically at how evidence gets submitted. Particularly as some evidence is going to be larger than 100 MB when it gets submitted, we’re going to have to address that as a part of that process. 

CT              Thank you, Michael. I think the next one might be for you as well. Will all the existing Word/PDF forms be replaced by the new portal, for example, the PPF form? Or maybe Alysha. Whichever. 

00:42:35

MD             I’m happy to take it, Cindy. So the aim that we’re working towards is bringing all of our forms into that document library, the form library that Alysha demonstrated earlier. The exact sequence is something that we’re working through at present. As we noted earlier, the first cab off the rank is that GMP Clearance process in our manufacturing evidence space. But we will be working through all of our TGA forms and paying particular attention to these Word/PDF forms that are a bit of a bugbear for many of our users. 

CT              Thanks, Michael. But just a reminder, in the new service layer, you will have all your forms available, and it will just be a continuous improvement process. The next question is, will GMP Clearances relating to new medicine applications be linked to the new medicine applications in the system? 

MD             That’s another one in my space, Cindy. So we’re keenly aware that the current GMP Clearance form is relatively minimalist, and it lacks data linkages. It doesn’t provide the context that we want to our assessors. So the form that we’re building at present is designed to be better connected and provide more context for our assessors, with an eye to speeding up that assessment process. 

                   And connecting things like the relevant medicine application or the relevant ARTG listing is something that we’re definitely looking into in our form at present. And I’m pretty sure that new medicine applications are one of the ones that we have linked, or at least it’s showing up in our prototypes at present. 

00:44:22

CT              Thank you. What is the assigned idle time while populating submission forms before a user is signed out? 

JF               I think that one’s probably me, Cindy, because I think that’s driven off the front-end portal. So the current idle time that we’re setting for go-live is 15 minutes, which is based on cyber and ASD best practise for an external portal. However, we will be informed through formal further engagements with the cyber teams and user requirements, etc. So we’ll take all of those into account before we go live. 

CT              Great. Thanks, Jen. I think some of the applications take a little time to fill out, so we’ll definitely pick that up in our user testing. I think the next one for you, Alysha. Will we receive automated emails after each stage has been completed? 

AM             Yes, that’s an excellent question. Thank you. So I think this question relates to probably a feature that we haven’t included in beta today around that messaging and notifications or alerts feature. So it’s something that we certainly could consider. 

                   But we’d want to do some more testing when we go through concept testing and beta testing on that messaging feature, because some people’s preference will be, I want an email every time something happens in the portal, and others might absolutely not enjoy that at all and be overloaded with emails. 

00:45:49

                   So we might look at what’s technically feasible for allowing users to maybe give their preferences on when actions occur in the portal, including there’s correspondence or there’s something there for you to action or something’s progressed to another stage, like the question asks. We want to test with industry what are those kinds of things they might want to be alerted to, and how they want to be alerted to, including whether it’s an email or something like that. 

CT              Thanks, Alysha. The next one, I think, is for Michael. It’s a really good question for how the case management system works with the new TGA portal. But what is the lag time between internal facing updates to the status of an application to sponsor, external facing? 

MD             Great question, Cindy. So to use a particularly technical word, the system that we’re building uses what’s called asynchronous processing, which means that as processing power is made available, it gets processed, in short. But from a user’s perspective, it’s going to be relatively instant. So the data on our portal is the same data as in our case management system. They are one and the same. So as it gets updated in the case management system, it’ll flow through to the portal. 

CT              So real time, as the assessor moves the application along to the next step, we’ll be able to show that on the sponsor side. 

MD             Exactly, all but real time. 

CT              The next question is, will we be able to access the timelines for previously completed submissions? 

00:47:31

AM             Yes, that’s an interesting one. And I’m assuming it’s how long things took for the submission to be completed, so a retrospective view of the progress tracker is how I’m reading that one. 

                   And no, that won’t be available retrospectively across all submissions. But it’s certainly something that we could explore with industry testing, to see whether that’s something that going forward might be useful to have, over time. And of course, when we’ve got that for new submissions, we’ll be able to see that progress tracker up until something was approved. And that information will remain with the submission. But retrospectively, no, not at this stage. 

CT              Great. Thanks, Alysha. Always good feedback for things we need to think about for the next iteration. The next question is, do I have to complete all fields on a page before I go on, or can I skip to the steps and come back later to complete them? 

MD             I think that’s one for me, Cindy. So the way that we’ve designed the form, each page gets validated by the user, or by the system. So as a person completes a page, the inputs that they’re putting in there is validating, and they’re then able to move on to the next page. 

                   You won’t be able to skip steps, because the inputs in the form need to be placed in there so that the form knows what to generate coming next. So the form will change based upon the user’s inputs, and the form can’t change without those inputs. What that does do is it makes sure that you’re only asked the questions that you need to be asked. 

00:49:16

CT              Great. Thanks, Michael. It’ll hopefully speed up how long it takes to complete your application. Will all payment processing be moved to the new system, or will invoices still be payable outside the portal? 

AM             Yes, great question. I’m happy to take that one. So we’re looking at supporting some of the existing functionality there is in T-Biz where you can complete invoice payments directly through the portal. But we know that you also go through a payment gateway, where you can enter in an invoice number or something. That’s through a service called BPOINT at the moment. 

                   So we are looking at updating that payment gateway. And yes, Jen, if you want to add any further, if you’ve got more information around that one. But we are looking at including a new payment gateway to still enable invoices to be payable outside of the portal as well. 

JF               Thanks, Alysha. Nothing further to add to that one. 

AM             Thank you. 

CT              Thank you. The next question is, for PPF submissions and subsequent full Cat One submissions, will the current multi-step process that we use, i.e. that crosses over multiple forms or areas of TBS, be streamlined so the process is simplified? 

00:50:31 

AM             Yes, that’s a really good question. Thank you, Georgie. So for go-live, we don’t anticipate there’s any changes to that particular process across the various forms. Those forms will still be available through that forms library that I demonstrated in the new portal. But as I think we’ve mentioned, incrementally, we’ll be capturing different forms and services and looking at how we can transform these to simplify the processes.

                   So this won’t happen to all forms at once but will be done in incremental batches. And this is to support also process updates internally that we’ll need to make to be able to cater for such changes, and will also require some further industry consultation specific to those particular forms and application types to ensure that any process transformation we do in that space meets requirements and is fit for purpose. 

                   So in short, still accessible from the new portal, will be in the same current way that you access them if they are through various forms. But in the future, we will look to transition that to have a more streamlined or simplified process through industry consultation feedback. 

CT              Thanks, Alysha. So the next question. Will the new portal be able to streamline or connect a GMP Clearance application to a related variation application? Michael, that might be you. 

00:51:57 

MD             Yes. So I don’t want to jump the gun with respect to discovery that we have happening at the moment with respect to GMP Clearance variations. But consider your question heard, and it wouldn’t be the first time that we’ve heard this one. So we’re still in the design process for how variations will look and feel, but I’d expect it to cover that. 

CT              Thanks, Michael. The next question is, what is the targeted timeline of implementation for this version? So assuming we’re talking about this version of beta, we’ll be taking the feedback through this beta session, and then look to implement it for a production version from mid- to late next year, so 2026. The next question is, will we be able to see the content of a submission after it is submitted? Alysha?

AM             Yes. So as we’ll be transitioning to the new technology stack, we’re looking at how we can better provide that submission summary view, so not just the progress tracker but then also being able to see what information was provided in the submission.

                   So as we incrementally do that, the experience you have today with seeing a print preview or whatever it might be that you access following submission to see the information that was provided will continue to be accessible in that same way. But yes, we will look, as we start transitioning the different forms, on how we display that submission information back to users. But yes, it will be the same for the various forms or submissions as it is today. 

00:53:41

CT              Thanks, Alysha. The next one, we’re back to GMP, so Michael. Will the current GMP Clearance applications and renewal applications be migrated and managed by the new system? And is there any expected problems? 

MD             Yes, great question, Cindy. My expectation would be that applications submitted in the current state system would be processed through the current state system and new GMP applications submitted through the future state system would be picked up in our future state, if only to avoid those expected problems. That being said, we’re looking at how we move actual clearances themselves, so those clearances that are granted, into our future state. 

CT              Thanks, Michael. The next question from Ron is, is the aim to move all future correspondence between sponsor and TGA to be via the portal? 

AM             Yes, great question, Ron. So I think, as I said before, we’re still exploring the entire functionality of correspondence and messaging and how that works across both the portal and the TGA internal. But the intent is we really want to avoid using those back and forth emails where possible, and do as much as we can through the portal itself. So the intent is that the correspondence will occur through the portal. 

                   But there also may be some circumstances that still require email. So I don’t want to say that that will totally be wiped out, because there’s some use cases that that certainly is appropriate. But the intent is to utilise as much of the portal as we can for correspondence. 

00:55:23

CT              Thanks, Alysha. The next one is a similar vein, but will the new portal retain data such as email correspondence and documents uploaded during submissions, and will that be retained for posterity? 

AM             Yes. So that’s a good question. I think that’s related to, I guess, maybe a data migration question of what information that I’ve historically provided will still continue to be available on the new portal. And the answer to that is we’re migrating everything. So everything that you can currently access through the T-Biz portal today will continue to be accessed through the new portal once it’s released. 

                   And I guess if you’ve got email correspondence attachments, for example, associated in the current portal, those will remain and still be accessible in the new portal. But we also are looking at exploring improved document upload functionality as well, and how that process will work. But rest assured, everything that you can access today will continue to be accessed as we go live in the new portal. 

CT              Thanks, Alysha. Continuing on the data front, will users be able to export data as Excel reports through the new interface? 

AM             Yes. So there is an export function currently available. And I believe this comes through various, both Excel and maybe an XML or HTML view. And the intent is that that will still remain, that you’ll be able to export the various reports as required, including the submission dashboard view. So if you want to get a view of all the different submissions that are made, that’s that export functionality that we’ll also make compatible with Excel. Yes. 

00:57:07

                   We can also explore through further testing if there’s particular things you want to be exporting. So maybe for some, that’s certain information that might not be captured in the dashboard. If there is, please let us know so we can explore if we need to add export functionality in certain places. But certainly in all the places you can currently, they’ll be replicated to enable that functionality. 

CT              Great, thank you. The next question is slightly different, but will there be any changes to roles, for example, drafter or financial, etc.? And does a particular role change the look and feel or look and access to the portal features? 

AM             Yes, great question. No intent to change the roles as they currently are and what kind of functionality, say, a finance role would do versus a drafter or submitter role or an org admin role. The only difference is how they interact with the actual portal. So through that new login process, there will be some changes on how org admins, for example, add new users to the system. 

                   So in the next round of beta, we’ll be looking to test that further with users on that process of an org admin adding contacts and having those contacts come through the front-door portal and then through to TGA. There will be some minor functionality changes on how that occurs. But in essence, the roles are not looking to change more broadly than that. 

00:58:41

CT              Great, thanks, Alysha. The next question is, while printing a submitted device inclusion application, can we also see the attachments that were uploaded into the application in this printed page? Currently, it won’t show the list of documents submitted. 

AM             Yes. That won’t be available for go-live immediately because it will replicate what the current system shows for when you do that print preview or also what’s currently included in that space. So that won’t change, but it’s certainly good feedback for us to consider as we transition some of those forms and functionality over. 

CT              Great. Oh, this is a good question from Daria. For the go-live or transition to the new system, will it be a hard changeover, i.e., everything in the new system on Monday is closed, or everything in the old system is closed, and then you move to the new system? Or will there be a transition period? 

AM             That’s a great question, Daria. So the intent is that part of this beta is to provide a little bit of that transition period, and then incrementally provide changes to the processes themselves. So on day one, which you’ll get plenty and plenty of communication about as we reach that go-live date, the intent is that on go-live, you will normally go to the T-Biz portal, you will be redirected to the new HBSP portal, which will provide you with the ability on how to log in. And you’ll have all that communication ahead of time to be able to support accessing the new portal. 

01:00:27

                   And all of the same processes that you do today will be done through the new portal. And we don’t intend to have both running alongside each other, because then that does tend to create a few data integrity issues if you’ve got two sources of truth coming through for different things, and it actually might create a more confusing user experience. 

                   So the intent is that, like you say, on a Monday, you will then go through into the new portal and will go through the steps that you normally would in the new space. But there’ll be plenty of comms leading up to that moment so that it will be hopefully not a headache for anyone. 

CT              Thanks, Alysha. Yes, there’ll be a runway into the changeover, with lots of training and support for the new system. I might take two or three more questions. Michael, I think this one’s for you. A hurdle we are facing in terms of GMP Clearances, when TGA asks additional files from API sites, usually don’t want to share two documents to sponsor. They want to share directly to TGA. In that case, the size constraint is only 20 MB. What’s proposed to improve this aspect of file sharing? 

MD             Thanks, Cindy. And it’s a great question. We have, in September, conducted a survey of our international manufacturer cohort to get an understanding of problems just like this. And we’re looking at ways to better involve manufacturers in that GMP Clearance process to get over hurdles like this, ways that we can perhaps bring them into the portal and move them away from email communication. Because we are aware that, A, they do want to be involved in the process, and B, the current process has limitations exactly like you pulled out. 

01:02:19

CT              Thanks, Michael. Will milestone or approval letters be visible or accessible in the new portal? 

AM             Sorry, just finding my mute button. Yes, it will be. We’re exploring the best way to surface these to users, which will come in the next round of beta testing. But the intent, yes, that they will be available in the new portal. 

CT              Thanks, Alysha. And just last question for today, but as I said, we will make sure we get all the questions that we aren’t able to answer today and publish answers. But once a submission moves to approved, does it still appear in the submissions list? 

AM             Yes, it absolutely does. So we know that you want to see the history of submissions, even though they’ve been approved. Yes, they will still be made available. 

CT              Great, thank you. And thank you to the panel members for joining us. And thanks to everyone for your insightful questions and some good feedback. So just to wrap up, we’re always reachable via email. So please get in touch with us if you’d like to or want to share more feedback. In the coming weeks, we’ll be publishing this webinar and responses to the questions on our webpage, as I said. 

01:03:39

                   On the webpage, there is a new Business Services tab. That is where you’ll find this information, but also where you’ll find access to T-Biz and the new T-Biz portal in the future. If you haven’t already, it’d be great if you filled out the short satisfaction survey about today’s session, and also keep your eye out for the videos to be published on our website on 16th December. 

                   You’ll see a video that goes through the TGA portal, like what you saw today, as well as a demonstration, a more detailed demonstration of the case management solution behind the scenes, and the start of a GMP Clearance form. Lots of questions about GMP today. So please have a look at that video, fill out the associated surveys and get your feedback back to us. We will email all participants today when this information is live on the website. 

                   And in terms of future beta testing, we’ll continue to work on our next round of features, which means there will be another set of beta testing before we go live. And if you would like to be a part of that, please go to the QR code on the screen and register your interest. We always like to have a large pool of testers so we can share the workaround, but also, it really is a good opportunity for you to play a role in the development of those solutions that you’ll use. Your feedback really does directly influence our design and improvements. 

                   And if you do choose to participate, we’ll reach out to you within a few months to invite you to those different activities. It might include surveys, interviews, usability tests, and the involvement sometimes is as little as a few minutes or up to an hour, depending on the activity. And your participation is voluntary, so you can opt in or out at any time. Please subscribe to our mailing list if you’d like regular updates, and keep an eye out, as I said, on the tga.gov.au webpage for updates on digital transformation. 

                   So just to draw this webinar to a close, I just want to thank you all again for your time and your interaction with us today. Please, if you want to stay up to date with TGA more broadly, subscribe to the newsletter and to those social media channels. But thanks again for your time. Goodbye, and have a great afternoon.