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Hello, today I'll be demonstrating our internal

case management system which is currently being used by the Office of Drug Control.

Recently, work has been completed on the feature

Workflow Steps.

Workflow Steps integrates and syncs the external portal to the internal case

management system.

This means that as the case workflow progresses internally,

external applicants are kept up to date of the progress by the Health Business

Service portal.

As new areas on board to the case management system,

they will also be able to take advantage of this functionality.

When an application is submitted on the portal,

a corresponding case record is created in the case management system.

As a case owner, I can use my dashboard to find this case

record or I can select on the cases tag and using the submission Idi can locate

the case record that I need to progress.

When I open the case record, I can see the details of the applicant

and any details that they've provided for the primary or alternate contact.

On receipt of a case record, a workflow step is immediately inserted

and sent to the portal alerting the applicant to the fact that we have

received the application.

In this demonstration, I'm going to be progressing the case

workflow which will update the external portal milestone from Application

received to payment received.

I can only action items that are in a new status.

Action items with a pending status have a prerequisite which much be completed

before the action item can be commenced.

In processing this action item, a Case Workflow step Payment Received

will be inserted into the case and this will be sent to the portal for the

applicants consumption.

I can see these milestones as they're appearing on the portal by using my Case

Workflow Steps tab.

In this instance, I can see that I have launched a Payment

Received in Progress milestone and that last action item will mark that as

Payment Completed.

Once the Case Workflow step has run, I can now see that that milestone has

been completed.

As I work through each of the action items in the case workflow,

corresponding Case workflow step will be updated and sent to the portal.

This allows the portal an the case to remain In Sync throughout the life of the

case record.

Today I will be demonstrating the work the TGA has done on the new Good

Manufacturing Practice Clearance Application form,

also known as the GMP Clearance Application form.

This video is intended for industry stakeholders who are interested in the

progress and direction of the new GMP Clearance application form.

I'll be showing you the new form, pointing out some new features,

and explaining the reasoning behind these changes.

To help with this demonstration, I'm going to complete the form using fake

companies.

Please note that this is a prototype and is limited to a "New" GMP clearance

application.

As such, it is subject to change based on feedback

and ongoing development.

We anticipate making iterative updates after this release.

For the purpose of today, I'm an agent for a company called Cann

Health Australia Pty Ltd.

The sponsor I'm working for is Southern Cross Therapeutics and we are seeking GMP

clearance for BioVerde Labs Inc. in the USA.

This demonstration is being shown in a desktop view.

Please note all names and addresses are fictional for demonstration purposes.

OK, let's get started.

This page is our landing page, where the applicant will sign into their

Health Business Services account.

So let's go ahead and click the sign in button.

On this page, we go to the Services tile and select

Therapeutic Goods Administration.

Then we go to the Forms library, and from our Forms library we select the

GMP clearance application.

Here you'll find a brief description of this form,

some background on the information required, and associated costs.

Based on the feedback from user testing in August,

we have also added links to TGA resources.

Now we have progressed to the start of the form.

The left-hand bar shows the progress of the application.

Details displayed on this screen and throughout other sections of the form are

drawn from the organisation records.

As a result, you will notice text advising applicants

to contact the TBS Helpdesk if the details are incorrect.

This is because the information likely needs to be updated in the organisation

section of the portal.

For your first question, you need to select the sponsor.

For this application, mandatory questions are marked with red

text and must be completed to continue through the form.

As mentioned earlier, in this example we are an agent.

Let's select Southern Cross Therapeutics as our sponsor.

The drop down will only show options that are linked to your organisation account.

Now, we have to list a primary applicant

contact for this application.

Let's go ahead and select Sarah.

There is an option to put in an alternative contact.

From our early-stage user testing, there was strong interest in being able

to include a second contact that also receives notifications regarding this

application.

Let's add in Jane.

This completes the first step of the form.

Let's save and continue to the next step, address details.

Here we will select the applicant's postal address.

Next, it is going to prompt us to select the

street address of the sponsor.

I can save my progress at any time and come back later.

Everything you've entered will still be there.

Let's progress onto the next step.

We are going to search for our manufacturing organisation.

Let's click on the search icon here.

You could search by manufacturer name or ID.

We are going to select BioVerde Labs Inc.

Now, we need to select the manufacturing site.

This is the site that requires GMP clearance and where most of the

manufacturing steps take place.

You will then be able to identify additional manufacturing sites.

This is an enhancement to the current form and in alignment with other TGA

processes such as Certification.

However, this is strictly limited to certain

situations for GMP Clearance.

For example, a storage facility that is overseen by

the primary site but is unable to obtain its own GMP Clearance.

Great.

Let's continue onto the next part of the form.

This is the Associated products and submissions page.

This page is still under development, so will most likely be updated as we move

forward.

This section expands on the current-state GMP Clearance form.

Questions around the purpose of the application.

A GMP clearance is always related to a therapeutic good already on the register

or a submission to include a good on the register.

This expanded section will allow the TGA to triage and prioritise applications

according to need.

This should also help reduce the number of questions asked of applicants during

screening and evaluation, making the process smoother.

The first question asks if the GMP clearance is in relation to an existing

ARTG entry.

Let's say yes.

The applicant can search by either the ARTG ID or the ARTG entry name.

As you type, the system will show relevant records for

you to choose from.

The lookup will be limited to records that are linked to the sponsor.

This is a new feature that demonstrates better system linkages and data

integration.

Let's add HUMALOG U200 and confirm.

A question will appear asking if you intend to vary the ARTG record.

I'm going to select YES and add the date of 18 December 2025.

This will help the TGA triage your application during screening.

The second section is for Prescription medicine product submissions.

It allows you to link your GMP clearance application to an in-flight product

submission.

When selecting YES, the applicant can select a product

submission that has been submitted for prescription medicine.

This is another example of the improved system integration.

Let's add Insulin Lispro Injection.

Continue, confirm and continue onto the next page.

Now we are at the scoping questions.

The purpose of these questions is to better understand the specific product

categories and submission types.

This will inform future selections in the application form and later assist with

triaging and evaluation.

The questions presented will be dependent on the product.

As GMP Clearance can relate to a broad range of therapeutic goods.

The product labels you see here are not final.

In this example, we are applying for a site that

manufacturers both API and the finished dosage form of a prescription medicine.

Being able to apply for both API and finished dosage forms in one application

is an enhancement based off feedback from industry and TGA users.

Let's go ahead and select NO as the answer to the first question.

As you'll notice, once a question is answered,

another may appear if it's linked or related.

Some questions also include additional context to help guide responses for the

next question.

Are the products registered, listed, or biological?

If you have products related to more than one category,

you can select more than one answer, and will be asked questions related to

your products.

For the purpose of this demo, we are only looking at registered

products.

I'm going to select my answers in this section and will point out areas of

interest as I go.

When we get to this question, is the application for finished products,

APIs, or both?

If you want to take advantage of the enhancement or apply for finished

products and active pharmaceutical ingredients,

this is where you can now select both.

I'm going to select new submission.

It's going to be a Category 1 submission and a new chemical entity.

For this new next question, do you intend to use any of the following

pathways?

You can choose to select something or if none these apply, you can skip this step.

Here I'm going to say API and Finished Product.

I click continue on to the next page.

In this section, we'll be looking at Active pharmaceutical

ingredients, also called APIs.

Here, you can tell the TGA which ingredients

are relevant to your GMP clearance.

This includes APIs, high risk recipients, and intermediates.

This page will only show if you selected APIs as part of your scope in the

previous section.

If you don't have API's, you won't see this page.

Let's add an ingredient using the lookup record.

To do this, select the search button and look up a

record.

We're going to look for Insulin Lispro.

If the ingredient was not found, you can select this option in the bottom

corner allowing you to add an ingredient using free text.

An example of when it might be appropriate to use this is if you are in

the process of registering a new ingredient with the TGA,

but are still waiting for that to be finalised.

Click Insulin Lispro and continue.

Next we need to confirm if this is a high-risk excipient.

For this run through we will select NO and confirm.

This has now been added to the table below.

You can see here we have added a column labelled Synonyms to help applicants

identify ingredients that may be known by an alternative name.

This new feature improves clarity, especially when different stakeholders

refer to ingredients using a different name.

We're now going to speed up the process of adding these ingredients.

Now that we've added all of our ingredients,

let's move on to the next step.

Now we have progressed to manufacturing steps.

This is a key part of the application where you will specify what manufacturing

steps you want the site to be allowed to do under the GMP clearance.

This section brings everything together using information you entered earlier.

Similar to the previous step, select, add and choose the manufacturing type

from the drop-down button.

We had feedback that a link to the code tables would be useful,

so this has been added.

Let's select Active Pharmaceutical Ingredient Manufacture as our

manufacturing type.

This will trigger a series of single-select questions presenting one

question at a time.

I'm going to select Sterile and Non-Sterile.

For Manufacturing class: Not Applicable. For Dosage form: API - Not Defined.

Product code: Registered Therapeutic Good and Manufacturing step: Active Material

Manufacturer.

For the question about the site performing the step - if back in the

manufacturing organisation page you listed additional sites,

you now need to specify which site that is performing the step you are currently

adding.

As mentioned earlier, additional sites will only be appropriate

in limited circumstances.

Similarly for the next question, if you selected that this application is

in support of an ARTG listing, you now need to specify which ARTG

listing is associated with this step.

Some questions, including this one, will allow multi-select and a select all

option which was suggested in user feedback.

If a field such as ARTG listing appears but no ARTG listing has been supplied

earlier in the form, the field will be disabled.

I'm going to select 7890 Precision Way.

My ARTG listing will be HUMALOG U200.

My Associated Products: Insulin, Lispro Injection,

and Material Types will be Starting Material.

When you get down to the 'API this step applies to',

you'll be able to select from the ingredients you added earlier.

For sites with a lot of APIs, the new form should be a more efficient

way to capture the information.

I'm going to select APIs Insulin Lispro, Biosynthetic Human Insulin and once all

questions are completed a line will be added to the table displaying the

high-level manufacturing step details.

We are now going to quickly populate the rest of this table.

Now we can see a complete list of manufacturing steps for a GMP clearance

application.

The Step ID is a hyperlink that opens a detailed view of the inputs.

If you've made a mistake, you can go to the Actions column to

delete a step.

If you listed ingredients earlier in the form,

you must make sure that they are covered by at least one of the steps.

You won't be able to progress to the next part of the form if you have ingredients

that aren't linked to any steps.

This will help make sure that you don't accidentally submit an incomplete

application.

Once you've added all your steps, you can move on to the next step of this

application.

This is the Pathway identification page.

This new page ensures the applicant applies for GMP Clearance using the

correct pathway based on form inputs and available evidence.

This helps to make sure that people don't apply and pay for something they don't

need.

The initial question asks whether the applicant intends to use a Letter of

Access.

We're going to select no.

The authorisation to access other applications or evidence has not been

finalised.

The next question asks which regulatory authority completed the inspection with

the drop-down button of TGA's recognised regulatory authorities.

When you select your regulatory authority, we intend for the form to run a check

against your site location.

If the combination is not accepted within the TGA's Inspection Reliance Framework,

an alert will come up.

For example, you may recall the site I selected

earlier was in the USA.

If I select Korea, I am prompted to use the TGA

certification pathway.

For this application, we're going to select the US FDA as our

regulatory authority who last inspected the site.

In this example, we will select GMP Inspection Evidence as

our Primary Evidence.

Then we need to add the date of the inspection.

If the user selects a date that is out of the valid timeframe,

the system will let the applicant know, so they know they will need to use

different evidence.

So, let's select a date.

And the next question that comes up will be,

"Did the inspection cover the specific scope of your application?"

Here I'll say no.

I will then say I have additional evidence to cover the scope.

I now need to select from the drop down the additional evidence I'll provide to

cover the scope.

Here I will add API declaration.

The form automatically runs a check and provides the eligible pathways.

We can see here that our application is eligible for the Inspection Reliance -

Compliance Verification and inspection by the TGA pathways.

We then confirm which pathway we are choosing.

This is another area we are still working on, so it might change in the future.

We are going to select the Inspection Reliance pathway.

You may have noticed earlier that 'evidence unavailable' is an option.

This confused some people in previous user testing.

The question is there to guide applicants in situations where they may need to

apply for an inspection by the TGA instead;

or in cases where the TGA can obtain the evidence from the overseas regulatory

authority on your behalf.

If you went down this path, you would also have to acknowledge there

is an additional fee for this.

Going to click continue here.

The applicant uploads their evidence.

In future we may allow manufacturers to add evidence too,

but this is still under consideration.

We have received feedback that it can be hard to know what evidence is required in

the new form.

We plan to have built in logic so that you will be provided with a list of the

required evidence based on the selections in the previous pages of the form.

On the top of the page a guide is provided for extra context.

There are three sections, primary evidence,

secondary evidence and optional evidence.

You can see for primary evidence it's required that I add a GMP certificate or

equivalent.

Let's select Add File, select GMP certificate or equivalent,

give our GMP document a title, a date of issue, an expiry date,

a version or revision number.

Note that no translation is required and add a file here.

We can upload a file, or we can drag and drop a file onto the

screen and hit confirm, hit continue.

A similar process is repeated for Secondary Evidence and the user can also

upload optional evidence again following the same process.

Now if I didn't upload the required evidence and I try to continue,

I'll get an error message telling me the evidence that I need to upload.

Once all evidence has been uploaded, we can now progress to the next part of

the form.

This is a step where the applicant can review all the inputted data for the

application on a single page.

This is a new function that allows the user to review the application and

provides a link to be able to edit. At the bottom of the page

Required declarations will be presented for completion.

Now I click continue.

As a final step.

We can see what fees will apply based upon what we have requested in our

application.

Please note that the TGA is still determining how payments will work in the

new portal.

This page has been added mainly as a placeholder for the purpose of this

demonstration.

Once you've reviewed the fees, you can submit your application.

Now the application has been submitted. The applicant can select Done and go to

their submission page to see the status of their submission.

We hope you've enjoyed this look into the direction we are taking for the new GMP

clearance application form.

The changes we have made are intended to streamline processing,

improve data integrity and support applicants to provide high quality GMP

clearance applications.

We look forward to sharing additional updates and features as they are refined

and we build up to the initial Production release for external users.

More resources will be available soon at tga.gov.

au to provide comments or feedback.

Contact us at TGADigitalStakeholders@health.gov.au

Thank you.