Presentation: The Procedure for Recalls, Product Alerts, and Product Corrections (PRAC) - What you need to know

Speaker Key:

JC: Jack Casey
NC: Nathan Coleman
CD: Craig Davies
SB: Sharon Bennett

00:00:00

JC Good afternoon, everyone. So, in attending today, we're assuming that you're already aware of the Recall Reforms Program, so we won't be retreading too much of the background. By the end of this webinar, you will know why the PRAC was written, the changes between the URPTG, that is, our current process document, the Uniform Recalls Procedure for Therapeutic Goods, and the PRAC, which is the Procedure for Recalls, Product Alerts and Product Corrections.

We'll also go through what you should be doing to prepare for the change and what else will happen when the PRAC is published. I've selected some pre-webinar questions, as well as some frequently asked questions, and I'll address those before opening the floor for Slido questions at the end of our session today.

So, why is this all happening? It's a long story, but I'll keep it brief. The URPTG has been in place for over 25 years. Throughout that time, we've received various comments and suggestions about how we can improve it. The earliest recent development came from within our division as part of an action plan for medical devices.

00:01:10

Among other projects, an action plan for medical devices made a commitment to review the legislative powers available for recalls. I'll take a moment to assuage any fears. The URPTG, our legislative powers and the PRAC covers not just medical devices, but also medicines, bloods and biologicals, and, of course, medical devices.

You can see here some of the first consultations, which helped to determine the scope of our reforms. The Manufacturing Quality Branch Operating Review in 2020. Then, later in 2020, a large stakeholder workshop about the recalls process. And then, in 2021, some external consultation work with the Synergy Group. These early consultations informed this list.

Now, don't worry. I don't expect you to try and read the screenshot. Each brown cell here represents a finding or suggestion to improve our processes. As you can see, there were a lot. Following those early discovery activities, we ran extensive workshops with various stakeholders and held internal reviews of our processes.

00:02:15

The feedback from these activities were compiled at the end of 2022 into our consultation paper, which we then published in January of 2023. This paper posed 38 questions to our stakeholders, grouped into themes such as communication, action descriptions, understanding of recalls, and improving our documentation.

Following our analysis of all responses to this paper, we determined the most popular pieces of feedback. This feedback was received across the different stakeholder groups and themes. Put key information upfront in our comms, change the recall action terminology, which under the URPTG can be confusing, clarify and simplify our processes, for example, the number of progress reports required for recall actions, the timing of releasing recall information, our recall risk assessment process, which I'll be speaking to later, and our early advice notices.

Then provide new and improved templates for submitting recall information. This includes allowing newer digital methods like QR codes and e-surveys to improve response rates.

This feedback informed our Recall Reforms Program. And in terms of what has changed since the discussion paper, version 2.4 of the URPTG, which was released last March, addressed the feedback which didn't require an IT project to achieve. This included the removal of the two-week action initiation report, removing repeated and outdated guidance, and clarifying our processes, such as detailing when and how sponsors should contact us.

00:03:51

Sponsors should involve the ACCC, as well as further detail about our early advice process, which we actually took the feedback from the consultation paper further, and now permit sponsors to review these notices prior to sending them out. To implement the terminology changes, our IT systems would need to be updated. So, with the release of the PRAC, what's changing? Well, first of all, something to note. The PRAC is not an update to the URPTG. It is a blank page rewrite of our procedure. The act of submitting an action will largely stay the same, but now the PRAC is written with sponsors, agents and consultants, i.e., you, in mind.

Anyone is free to read the PRAC and become acquainted with the recalls process. But since sponsors and agents and consultants are typically responsible for carrying out actions, and to that point, I believe 90% of our attendees today are from industry, we refer to the TGA as ‘us’ and to the reader as ‘you’.

The PRAC features the popular terminology changes from the 2023 discussion paper, reducing the number of actions from the URPTG’s 8 to a more manageable 4. We'll get into those in more detail later. This process is a lot easier to follow. The language and style in the PRAC is more approachable, and the word count is one third the current URPTG’s. And finally, the most important change, the PRAC and associated IT changes come into effect on the 5th of March. In the meantime, you can read it now on the TGA website.

00:05:32

So, in the coming slides, I'll be getting into the changes between the URPTG and the PRAC. And I've picked out key changes. This presentation won't go into every single wording change.

We'll compare screenshots from the URPTG and the PRAC to illustrate the difference between these documents. The screenshots you'll be looking at, and this is important, do not need to be read. Where there is a relevant piece of text, I'll highlight it in the presentation, point at it with my laser pointer, or read it out to you.

Now, because both the PRAC and URPTG are text documents, I've colour-coded each screenshot. In this presentation, URPTG screenshots are yellow tinted, and the PRAC is blue tinted. This is for illustration purposes only. They're not colour-coded on the TGA website.

I've tested this out on a couple of screens, and unfortunately, the effect may be faint depending on the screen. I've also considered blue-yellow colour blindness. So, for this presentation, I've also arranged each screenshot so that when I show a side-by-side comparison, the URPTG will always be on the left, and the PRAC will always be on the right. Otherwise, I'll announce whether a screenshot is from the PRAC or the URPTG.

So, let's jump into the most fundamental question. How do you access this content? To access the URPTG, you'll search for it using your search engine of choice, open the web page, and then select either the PDF or the Word copy of the document. This then downloads to your computer automatically. You can then open it and read it normally.

00:07:04

To access the PRAC, you'll search for it and open the web page. The entire text is available immediately, right in front of you, on a single page. It has the added accessibility benefit of being screen reader friendly. Even the graphics that we've put into this document will be described in full when put through a screen reader. As with the URPTG, you can download a pdf of the PRAC. Currently, this is done by selecting the print button and selecting print to PDF in the print dialogue screen. The TGA website team are working on implementing a dedicated PDF download button.

We've also taken advantage of the new formatting options available on the TGA website. Posting the document in HTML format allows us to offer readers a banner while reading that allows you to jump between chapters, as well as anchor links that will let readers click on a header and then paste the link that will direct readers to exactly that header in the document. Very useful for the new market action definitions, because you can paste the link into an email or work instruction, anything, and it'll bring you right where you want to go in the document.

While we're looking at those headers, let's talk about how we've arranged information in the URPTG versus the PRAC. This is the end-to-end recall process, as stated in the URPTG. Now, for $50, and without anyone looking it up, can anyone name all 10 steps of the URPTG? Anyone at all? I know you're all on mute, I just wanted to see if you're awake.

00:08:37

This is the process unblurred. It's a lot to remember, especially when the steps don't intuitively flow one into the other. Veterans of our GMP form presentations might remember this slide. This is how we described our process during the early discovery activities that led to the reforms program. It was this slide that influenced the current form of the PRAC the most.

This is the new 5-step end-to-end process in the PRAC. Step one, assessing your emerging problem. Step two, preparing and submitting your notification to us. Step three, TGA review. Step four, initiating your market action. And step five, finalising your market action.

Before you reach step one in either document, however, we've included instructions for immediate actions for when there is an imminent threat posed by a problem. So, side by side, here are the immediate action sections of the URPTG and the PRAC. On the left, the URPTG’s immediate action section. This is located on page eight of a nearly 60-page PDF.

On the right, the PRAC’s immediate action section, less than half a page. Once the PRAC takes effect, it will be the very first piece of information that readers will see. Our process remains the same internally, but to a sponsor who is, again, the intended audience of this document, you're going to be looking up this area while stressed. The problem poses an immediate threat to public health, after all. You want the key information upfront where you can see it.

00:10:14

What you don't want, what nobody wants, is for you to have to venture 8 pages deep and meet this first sentence here, which I'll read out you now. In circumstances where a sponsor becomes aware of a serious problem associated with a therapeutic good, an immediate recall action may be required. This is obvious. It doesn't need to be said. The headers that follow define tampering, contain links that will send you away from the area of the document you're looking at, and otherwise repeat and rephrase the same information.

The PRAC’s process is very similar to the URPTG’s, but it's condensed. It keeps the key information upfront. In an emergency, I know which I would rather read. It is written in unassuming, plain English, and its brevity means that users can read everything and understand what they need to do in under a minute.

Now, this comparison isn't going to go through the steps in order, but we will now briefly look at the first steps in the PRAC and URPTG. If you're submitting an action to the TGA, you likely don't have all the information to hand. It is, after all, an emerging problem. We just want you to have the details of the affected goods and a risk analysis. You'll be preparing the recall-specific documentation later in the process.

In the URPTG, this is covered in the first two steps. Since you'll submit the action to us after these steps, these should be written concisely and to the point. This is a lot of pre-reading before you can begin to submit an action to us. More awkwardly, it makes specific demands of risk assessment templates, ignoring the fact that risk assessments are often written by overseas manufacturers, who then supply the document to sponsors to hand over to us.

00:12:04

It puts sponsors in a difficult position. Do you follow up with the manufacturer, URPTG in hand, pointing at the requirements? Or do you supply the risk assessment, knowing that it doesn't satisfy the URPTG? Or do you ignore the URPTG altogether and submit the notification without a risk analysis? We want sponsors to get to the point of notifying us with the information we want as easily as possible.

So, this is how we handle that same process in the PRAC. One step. Rather than repeating information across medicines, medical devices, and bloods/biologicals, as we do in the URPTG, we ask upfront that you know the key information, regardless of the type of good. And the second table here on the left specifies the information you should know specifically for the type of therapeutic good.

For the risk analysis, we say upfront that we will follow up with you if they do not address the points in this table. We're no longer making demands of the templates being used in industry. We also specify what you should do if you wish to notify the TGA of a problem prior to receiving a risk analysis. And the instruction to not provide private, personal details of patients to the TGA, that makes up a larger percentage of the text of step one.

Our next example will look at how the PRAC and the URPTG classify risk. On the left, this is the URPTG’s table of contents. On the right, this is the summary of step two of the PRAC, which is preparing and submitting your notification to us.

00:13:41

The URPTG lists the definition of type, class and level of action outside of the 10 procedure chapters. This involves some jumping around if you're trying to submit a notification to us while reading the URPTG, but at least it looks pretty concise. Once we navigate to that section, however, we can see that that single header on the URPTG links to 16 sub-headers, one for each class, one to introduce the examples, which are not always representative of how we would internally assess the problem, and 3 for each type of therapeutic good or class. This spans 3 pages, technically 4, and clearly does not help our stakeholders, who report feeling confused with how the TGA assigns the hazard classification.

And this is what we have for hazard classification in the PRAC. Less than 2 pages overall. We've taken out the example scenarios and opted instead to give the basic definitions of the hazard classes. Our justification for doing this: By this stage, you, as the sponsor, have the HHE for the problem. If you're also the manufacturer of the therapeutic good, you've drafted and approved the HHE yourself. You should know what the risk to end users is. You don't need to search for an example in the URPTG that matches your situation and reverse engineer a hazard class. In the PRAC, you read the concise bullet points and approximate the most appropriate hazard class.

00:15:13

The Recalls Section ultimately reviews the submitted materials in coordination with internal experts, where appropriate, and assigns the final hazard class. To add some transparency to our decision making, we explain our consideration for the worst-case scenario in our classification activities.

We’ll now look at finding action descriptions in the URPTG. And I'd like to start with a point about user experience. For this example, we're on page 15 of the URPTG. That's step three, deciding the type, class and level of recall. We want to look at the definitions of the different recall actions.

You select the type of recall hyperlink, and you're sent 10 pages ahead to the recall action descriptions. Assuming you can read past this sentence, ‘a recall is one type of recall action’. Then you'll find a thorough list of examples and conditions explaining when they might be appropriate. Well, maybe none of these fit your circumstances. You scroll back up to page 15 and you think, those didn't suit my situation, I wanted to do something else. You read down to the end of this page, and you click on Non-Recall Action.

This now launches you 16 pages ahead. And if you thought the description of recall action was bad, try the definition of product notification. ‘Provides information about a therapeutic good in a situation that is unlikely to involve significant health risks’. We can all agree that's quite generic and confusing. We've had sponsors, who will remain nameless, submit product notifications to us that ended up being Class I recalls.

00:16:54

Now, the PRAC. This goes back to our philosophy behind our updated templates. We want to put the instructions where they're needed. In this case, you need to know what the different actions are when you're submitting the notification. So we've located all of the definitions, class, type and level, all under step two of the PRAC, preparing to submit your notification to us.

With the reduced action count of the PRAC, all the information you need to know is spread across 2 and a quarter pages of text. And as with the rest of the PRAC, we wanted to keep things concise. In bold, you can see the shorthand for describing the purpose of the different market actions. What will the customer need to do to address an actual or potential problem with safety, quality, efficacy, performance, or presentation?

For recall, return or dispose of the product. For product correction, correct or fix the product. For product alert, know something about the product. And for quarantine, avoid use or supply of the product pending further advice.

Let's take a quick moment to review our current terminology. Eight actions categorised under the terms, recall actions and non-recall actions. And the new terms under one category, market actions. This is much more descriptive than recall action, which conjured to mind only one of the action types in the recall action category.

00:18:23

The non-recall actions, known as safety alerts, now join hazard alerts and product defect alerts under the new product alert market action type. And product notifications and product withdrawals no longer need to be notified to the TGA Recalls Section. In addition to simplifying our terminology, we're adding new graphics into our guidance. So, here's an example of one you'll see in the PRAC.

You'll see that the class and level is largely the same, the only change being that the word ‘critical’ will now appear in the titles of class I market action letters, and ‘urgent’ for class II actions, where previously the word ‘urgent’ was used for both, confusing customers who did not always understand the difference between class I urgency and class II urgency.

A note on action level. The action level categories have stayed the same as in the URPTG, but for the PRAC, we've reformatted the information to be more compact and easier to read and understand at a glance. I'll give you all a moment to review the different levels.

Now to move on to a change I'm very excited about. Let's look at what the URPTG says that sponsors and recalling goods. This is located in the Roles and Responsibilities section of the URPTG. Originally, this section was intended to allow the Recalls Section to communicate to the market our expectations for each recall stakeholder’s role in responding to notifications in the market.

This is not a bad idea, but because it comes secondary to the process, instructions that are written for consumers, for example, the only such instructions written in the URPTG for the lay person are located on page 48. Such instructions are ultimately not within the remit of the TGA to maintain as a regulator of therapeutic goods.

00:20:28

In the PRAC, we've rewritten this section so that it communicates specifically to sponsors how we expect them to handle specific recall stakeholders. This is everything we have in the PRAC concerning a sponsor's role, besides, obviously, following the 5-step end-to-end process. What we expect your QMS to cover to ensure that recalls go as smoothly as possible, and handling mock recalls.

The rest of the responsibility chapter details the different stakeholders involved in the recalls process, same as in the URPTG, but now written so it explains the different stakeholders from the perspective of the sponsor. For example, here's what we have about state and territory recall coordinators in the PRAC. Again, I'll give you all a moment to read this.

Related to state and territory recall coordinators, the PRAC introduces a process change that I think should be highlighted. The release of information from the TGA to state and territory recall coordinators is changing. Here's a diagram. The sponsor’s notification contains, among other things, the summary of the action, the draft customer letter, and the customer list. This is sent to the TGA, who then approves the action and the draft customer letter, sending it back to the sponsor, who then commences the action.

00:22:02

Two days later, the TGA releases its own summary of the action onto SARA, and sends the summary of the action and the customer list to state and territory recall coordinators, who then also follow up with the customer to make sure that they are aware of the action.

Now, the very perceptive among you will notice that I did not mention the customer letter in the list of documents sent to the state and territory recall coordinators in the previous step. This was a highly requested change during our discovery period, as well as throughout our consultation paper responses and workshops with state and territory health departments. Once the PRAC takes effect, customer letters will be sent alongside the customer lists to state and territory recall coordinators.

Another change is regarding the customer lists. Currently, the TGA edits these lists to remove extraneous details such as private data, the names and addresses of individual patients, which should not be supplied to us at all, and we'll also double-check the accuracy of these addresses. This is extremely laborious, especially when some customer lists number in the hundreds or occasionally low thousands.

It is not within the remit of the TGA to verify the accuracy of this data. The Therapeutic Goods Act specifies that a sponsor's customer records should be fit for requirements to expedite these actions.

Once the PRAC takes effect, the TGA will no longer review the accuracy of customer lists. We will still remove any personal data accidentally left in by sponsors, in line with our privacy policy. They will otherwise be sent ‘as is’, direct to state and territory health departments, who will follow up with sponsors directly if they are unhappy with the quality of this data. So you should ensure from now on that this data is accurate.

00:23:57

Speaking of customer lists and follow-ups, steps four and five of the PRAC specifically address matters concerning follow-up reports and closeouts. We have instructions for collecting responses from customers and how we expect you to follow up, and how to approach difficult to contact customers.

And as for consumer level actions, we've taken away some of the more dated methods of communicating and we've replaced them with something more modern. We want to make it as easy as possible to understand what you will need to do during an action.

Step five of the PRAC is finalising your market action. It's now far more straightforward. We want to put the instructions where they're needed. So the follow-up report templates will prompt you for all the information that you need to submit while you're filling it out. We have changed the wording somewhat around our follow-up reports here. I'll give you a moment to read this.

We've received some follow-up questions about this passage recently, so I'll reiterate, this is not a significant change from our current process under the URPTG. As of Version 2.4 of the URPTG, we no longer require the 2-week report. Currently, we have the 6-week, also called the interim report, and the 12-week or closeout report.

00:25:33

You can and should continue to notify us if you believe an action will take more than 12 weeks to close out. The reporting requirements under the PRAC, just like the URPTG, are flexible. We in the Recalls Section just need to agree to them first. If an action continues past the expected closeout date, we will impose additional reporting requirements so that we can stay up to date with the progress of your action.

So, we've established the background of the reforms program, what we've already accomplished with the URPTG Version 2.4, and we've looked at some key changes between the URPTG and the PRAC. What else is changing?

The Recall Action Templates page on the TGA website will be updated to reflect the new terminology and process laid out in the PRAC. We'll be fleshing out our approach to using legislative powers in a piece of guidance that will go up on the TGA website in the weeks following 5th March. A deprecated version of this guidance exists in the URPTG. It just needs to be separated out into its own guidance piece and aligned with current advice from our regulatory legal services team.

This approach to legislation goes hand in hand with the less prescriptive process in the PRAC. To go back to my earlier example about risk analyses, we will follow up with you if you do not provide the information we want. And if sponsors do not respond to these follow-up actions, we can leverage our information gathering powers under the Act, for example.

00:27:08

We prefer, though, to reach voluntary agreement with our actions. And thankfully, over 99% of cases end up going this way. For that fraction of 1%, we'll be able to take a swifter, stronger regulatory stance in line with the TGA's wider objectives.

Finally, SARA, the System for Australian Recall Actions, will be renamed the Database of Recalls, Product Alerts and Product Corrections, or the DRAC. The PRAC and the DRAC. Our DRAC updates make everything more user-friendly so that consumers and patients can access important safety information faster and with ease.

Currently, in SARA you can only search by product name and date. With the DRAC, you'll be able to search and filter by action ID, action level, action type, hazard classification, as well as responsible entities, i.e. sponsors. The DRAC will also continue to list our old actions, supporting the legacy terminology, such as recall for product correction, or, more recently, product defect correction. So you will still be able to find actions published since 2012, when recall data was first made available through SARA.

Regarding our new terminology, quarantine actions have never been published in SARA, and this practice will continue into the DRAC. They're often used as immediate stopgaps, which may progress from a quarantine into a different type of market action, which will then be published, or require no further actions once the quarantine is lifted.

00:28:41

So, with the PRAC coming into effect, there are a couple of things that you should be prepared for. First of all, you need to read the PRAC in full. This webinar time slot could be for 90 hours, and it would be no substitute for reading the document yourself. The second thing you should do is ask questions. If there's clarification you need, ask. When we come around question time, and before we get to the Slido, I'll be going through some questions and comments that we've already received.

We're also coming to the end of the familiarisation period, where both the URPTG and the PRAC are available on the TGA website. This ends on the 5th of March, after which point the URPTG will be removed and no longer in effect. If you're planning on updating your SOPs or your work instructions to reflect this, I would recommend you do so very soon.

So, as I said, on 5th March, as for what happens next, the PRAC and its associated IT changes will take effect. Actions assessed by us on 5th March will be processed using the new terminology. Actions assessed by us prior to 5th March will be processed using the legacy terminology. And I want to note that assessment is a stage in the TGA's review. If you submit an action to us on the 3rd, it may not be assessed until the 5th. We will communicate with you if this happens.

00:30:11

Legislative guidance will be published as its own web page. This guidance, by the way, will not represent a change to the legislation. The legislation is staying the same, as is the way the TGA as a whole uses its legislative powers. This legislative guidance will simply explain the different powers that can be used in recall scenarios. That will occur likely later in March, potentially April.

Like the URPTG, the PRAC will be a living document that we will continue to update. During the familiarisation period alone, we've received some very useful feedback from you. Here's an example I'd like to highlight. This is a passage from step two of the PRAC. We began supporting electronic response forms in 2.4 of the URPTG, and they continue to be supported under the PRAC.

A reader from industry came to us with concerns about this highlighted text. They pointed out that this could create problems when their electronic forms are distributed to multiple markets, for example, as part of actions that are also taking place in New Zealand. The highlighted text reads, ‘the electronic response for must match the text of the response form template’. This highlighted text is there because we wanted to ensure that the same information is collected in our electronic forms as would be collected in the email or hard copy response forms.

However, we saw the benefit in relaxing this wording, and so we've updated it. This is another benefit of hosting our content on the web. It's faster and less complicated to update a web page than Word and PDF copies, which means that we can deliver updates faster than we could with the URPTG.

00:31:57

And speaking of fast updates, I’ll now take a breather and hand things back to our TGA Learn section before we get into the Q&A. Okay. We’ll now move on to the Q&A section of this webinar. Just briefly, before we begin, the people in the room with me are Mr Nathan Coleman, Project Manager and SME for the Recall Reforms Program, and Mr Craig Davies, the Australian Recall Coordinator.

Reading out questions to us will be Sharon Bennett, who is the Assistant Australian Recall Coordinator, of the Recalls Section. Perfect. Now, before we get into the questions from the Slido… Oh, and also Ms Molly Maish-Rusnak will also be assisting Sharon with the Slido.

Now, before we jump into our most frequently asked questions, I'd like to address some of the questions we've received from attendees prior to the presentation. First up, is the PRAC still voluntary, like the URPTG? Yes, it is. Like the URPTG, however, we will follow up with you if you do not notify us prior to beginning an action.

Next up, will licensees be required to perform a mock-up of the PRAC? By this, I believe the question-asker means mock market actions or mock recalls. We've received a few questions about this, so I'll briefly point this out. Your QMS should specify how frequently you perform mock recalls. This is also specified in PIC/S. The PRAC says they do not need to be reported to us, but you may submit mock recalls to us through the TBS portal, if you wish. However, if you do, they must be clearly marked as such, so that we don't review them.

00:33:46

What is the cut-off of the TGA's assessment? From the 5th of March, the actions we assess will use the new terminology. Prior to that date, we'll be using the legacy terminology. And as I mentioned earlier, before the break, just because you've submitted a notification to us before the 5th does not necessarily mean that it will be assessed before that time.

Can you clarify due dates for closeout reports? As mentioned earlier in the slideshow, these are typically set at 12 weeks or 3 months following the assessment date. If you tell us ahead of time, with valid justification as to why your action will go on longer than 3 months, we'll adjust the reporting frequency accordingly so that we can stay up to date with your action. If you do not meet these set due dates, we will impose additional reporting requirements. Again, stay up to date with your action.

Can the responsibility of advising states and territories be transferred to the company conducting the recall? No. The TGA notifies states and territories as a form of assurance that customers will be contacted, separate from the sponsor’s actions. You are, however, free to reach out to a state and territory recall coordinator if you are struggling to contact a customer. They may have more up-to-date contact details.

Can you differentiate between recall approval and execution from a manufacturer's perspective? So, approval of any action is the responsibility of the TGA once provided with the proper documentation. Risk documentation, specifically, is typically the responsibility of the manufacturer to provide.

00:35:31

Once approved, a recall action can begin. The sponsor is typically responsible for executing the action, but if the good is being replaced or reworked, the manufacturer may be involved. If you're a sponsor who is also the manufacturer of the good involved in the action, you're responsible for drafting the risk documentation, submitting the required material to the TGA, and performing the action once approved by the TGA.

Are monthly consumption / reorder rate and approximate market share mandatory details to submit? I will briefly go back to that slide earlier about key information. The simple answer is no. However, if you believe, for example, that a recall would cause a shortage or supply disruption, then yes, we would ask that you submit those details to us. Likewise, if we believed an action could create a shortage or supply disruption, we will follow up with you for this information.

Other scenarios where this information may be relevant are, for example, consumer level actions, where we want to understand the distribution rate of goods, or where you may believe that the stock may have been fully consumed within the market, or other scenarios determined by us on a case-by-case basis.

Let's now move on to some frequently asked questions. Could you create a national database of recalls contacts? No. This was a popular suggestion in the 2023 consultation, which, unfortunately, is not feasible for the Recalls Section, for a variety of reasons. The TGA is responsible for ensuring the therapeutic goods available for supply in Australia are safe and fit for their intended purpose.

00:37:17

As an organisation, we have legislative powers that we can utilise to help us fulfil our responsibilities to the Australian public. These powers typically apply to the therapeutic goods industry, which the TGA regulates. Unlike with sponsors, we as the TGA do not have the ability to formally request contact information from private individuals or representatives of organisations outside of the therapeutic goods industry.

Even if this information were volunteered, our obligations under the Privacy Act would prevent us from making this information widely available, not to mention that it would be a cybersecurity liability for every listed party. Finally, even if none of these were concerns, such recall-specific contact information would require constant updating, which is beyond the scope of the TGA Recalls Section.

Ultimately, the responsibility for record keeping, as it applies to customers, lies with the sponsor. If you are struggling to get in touch with a customer, we would advise that you contact the relevant state and territory recall coordinator for that customer's region. They may be able to help you find up-to-date contact information.

Can you provide risk analysis templates for sponsors to use? We have not prepared such templates for version 1.0 of the PRAC, but we could consider doing so in the future.

00:38:40

The PRAC addresses risk analyses more simply than the URPTG does. We've clearly stated the information we want to see in risk analyses, and we advise that you submit a provisional summary of a risk document while you await the full report from your manufacturer.

Do all out-of-specification stability results need to be reported to the TGA? I'm going to answer this question specifically in relation to medicines. The URPTG and the PRAC specify that when there is a problem with a therapeutic good that could pose a risk to public health and safety, action may be required. Such problems could arise out of non-compliance to standards or manufacturing errors.

If out-of-specification or out-of-trend results pose no risk to public or patient safety, or where the efficacy, quality, performance or presentation of the therapeutic good is unaffected, or where the product has not been distributed to the market, you do not need to notify the Recall section. If you intend to vary your manufacturing processes or product dossiers, however, other areas of the TGA, such as the Pharmaceutical Chemistry Variation Section, for example, should be consulted.

The conditions of registration and listing applied to medicine ARTG entries require that you take appropriate regulatory action. For example, updating your dossier with the TGA and ensuring your GMP information is up to date.

00:40:15

Will all reports submitted and reviewed in RAMP be published in SARA and DRAC? All actions which have been published to SARA will be reviewable on DRAC. This means that recall actions from 2012 to 2025 and market actions from 2025 onwards will be visible, excluding actions involving bloods, clinical trials, and, with the move to market actions, quarantines.

I'll now open the floor to Sharon Bennett and Molly Maish-Rusnak, assistant directors of the Recalls Section, who will be reading the most popular questions from the Slido. Thank you, Sharon.

SB Hello. Thank you very much for that, Jack. So, bear with me. This is the first time I've done the Slido, so we'll see how we go.

JC Sharon, I'm sorry. I might have to stop you there. We don't have audio of you in the room.

SB  Can anybody else hear me?

JC  Yes, we can hear you, but we're just going to put it on the speaker in the webinar room. Okay. Go ahead, Sharon.

SB Okay. Sorry about that, everyone. A few technical issues. So, the first question from Slido that everybody is concerned about is, we recognise the web-based form of this document is easy to read and update. How will sponsors be notified of any changes to the web page so we can keep our SOPs, etc, current?

JC  Thanks very much for that question. Nathan, do you want pick up?

NC  Yes, I'm happy to jump in. I was having a think about this one when I saw it pop up.

00:42:03

Yes. So, we will make sure that sponsors are kept up to date. Even though this rewrite of the PRAC is a very significant rewrite, and we're hoping we won't have to make too many changes any time soon, it is going to be considered as a living document, and we will be making updates as part of continuous improvement as time goes on. If we make any updates that are more than a minor editorial change, we will send out notification to sponsors. We'll put a notice on the TGA website.

You'll also be able to see down the bottom of the page, the page history. And that will include any dates and a short summary of what changes have been made. But especially if it is a significant update, we'll make sure that the message gets out there.

JC  Perfect.

SB  Okay. The second question is, will TGA eBS functionality remain, meaning, shall we continue submitting the notifications as before via TGA eBS?

JC  Yes, absolutely. One thing that we haven't covered in this presentation, and we have in previous presentations, is that the new market action terminology will be reflected by eBS as part of that IT update for the PRAC that we covered earlier.

SB  Excellent. Okay. Now, this is quite a long question. Continuous improvement sometimes improves device performa

NCe. This may be due to a software bug being discovered, workflow improvements, or improvements in the device due to market feedback. When are these triggering the performance requirement for reportability?

00:43:43

JC   Nathan, do you want to take this one?

NC   Yes, sure. One of the main triggers currently in the URPTG for reportability is whether or not you've made an assessment that, and as this is about a device I'll say whether or not the device is defective, and whether or not, therefore, if there's any deficiencies in safety, quality, efficacy, performance or presentation. In the devices case, you can make an assessment as to whether or not the device still meets the Essential Principles.

So I think that is where you will try and make the delineation between whether or not something is a correction, you are actually fixing something wrong in the software. That would be, therefore, still something to be reported to us as a product correction.

However, if what you're doing is updating the software and making it a little bit better, but you're not fixing any deficiencies in safety, quality, efficacy, etc, and therefore the software and the device still meets the Essential Principles, that can then be considered as part of a continuous improvement or just a device improvement, and wouldn't need to be reported to us. If you're ever unsure, if something's very close on that threshold, you're not sure if the product still meets the EPs, reach out to us and we can make an assessment.

00:45:02

SB  Okay. So the next question is, do product notifications and withdrawals now not need to be reported to the TGA, or just not to TGA Recalls?

CD    Okay. The reference in the presentation to product notifications and product withdrawals is specifically in relation to those two action types in the current URPTG. So, I appreciate they are rather generic words, so if there are other obligations elsewhere in the regulatory system, say, if there's some kind of change to your pre-market dossier that you need to notify the relevant pre-market area of TGA to, those reporting obligations will still remain.

SB   Okay. Does the TGA recognise customer acknowledgement form from GS1 as electronic response?

NC    Yes, I can speak to that one if you want. Yes, generally speaking, we would. But I'm not sure if you mean, when you say the customer acknowledgement from GS1, because rather than just getting an acknowledgement that it being been sent via the GS1 portal to your customer, that therefore wouldn't be an acknowledgement. We want the actual customer to recognise.

If you mean via the GS1 portal, if you get acknowledgement that the customer essentially gives you a thumbs up to say that they have opened and acknowledged it, we would consider that. What counts as customer acknowledgement is something that has been discussed, particularly even recently, with several sponsors.

00:47:01

Ideally, we want to be able to get the best response rate possible. We want you to be able to try contacting the non-responding customers via multiple methods and multiple times. So, if you're having trouble reaching customers via the GS1 portal, reach out to them via traditional email, or pick up the phone and give them a call. If you're having significant trouble reaching customers, we might accept in the closeout that you haven't been able to reach them, but you need to show us a justification that you've made a valid attempt to do so.

SB     Okay. Has any consideration been given to recall fatigue, decreased sensitivity in the marketplace, due to the broad reporting requirements?

CD     I would say, yes, there has been, and that would be reflected in the reforms that were rolled out in March last year, by reducing the reporting requirements, by removing the 2-week report. So there's now only two reports required, rather than three. And another little tweak we've made that Jack highlighted in the presentation was the clarity around the recall classification, where class I actions will now be labelled as critical, whereas class II will be labelled as urgent, to provide some kind of clarity in that space as well.

SB     Okay. Is there any flexibility around whether customer acknowledgement is required under the new action categories? For example, if a situation occurs that would have been a safety alert or a product notification due to a low risk to a patient, is there flexibility around needing to gather customer acknowledgement?

00:48:51

JC    If you like, yes.

NC    Sure. We actually had this question the other day. Our reporting requirements are still flexible. However, what we've tried to do is, rather than previously where we had different reporting requirements set out in the guidance for different types of actions, we've tried to make it more consistent and standardised across.

So while, yes, we do say that all actions, if they're business as usual, would have that 6-week and 12-week report, if we did receive an action that was low-risk and would have previously been considered as a safety alert, and you're really just notifying the market, ‘hey, customers, you're using the product incorrectly, here's a notification, please do that’, we might not require the same degree of customer response or of requiring that customer acknowledgement form in all situations. So, it's flexible based on risk.

SB    Okay. Local closeout is different to the manufacturer’s closeout, as a manufacturer needs to complete an effectiveness check. Local closeout is more concerned with correction and corrective action. Which does the TGA consider the final closing report?

JC   The final closing report will typically ask for a CAPA from either the manufacturer or the sponsors also, the manufacturer and the sponsor as well. So, that is a requirement for the closeout report, is a root cause analysis for the problem. So, as soon as that's done, and we're satisfied with the completion of the action, that is what we would consider the final closeout report.

00:50:38

Templates for the closeout reports are included in the agreement letter. And like I said, the instructions for that agreement letter, or rather, closeout report, are included within the template. So you should know everything you need for the closeout report.

CD   And from an Australian legal perspective, that would be information coming to us via the sponsor. Now, sure, they might provide information that comes from their manufacturer as well. But it is ultimately the sponsor's responsibility to provide the information required in those interim and final reports that we will assess. And once we are satisfied that the market action has been conducted effectively and efficiently, then we will agree to close that out with the sponsor for the Australian market.

SB    Excellent. Will the TGA be compiling a list of Q&A relating to PRAC on the website?

JC    This question-asker is after my own heart. This is something that I would really like to put up on the TGA website, and we're discussing it internally.

SB    Okay. Does state recall coordinator cover private institutions as well as public hospitals?

00:52:00

CD   Our understanding is that there is a mixed approach in that regard, and it often depends on the size of the state and the number of healthcare facilities there are. For example, in some of the smaller jurisdictions, where there's only a handful of public hospitals that those recall coordinators have close relationships with their private hospitals, that may not be as possible in the larger jurisdictions. But it is a mixed approach, and it is based on the positions adopted by each state and territory health department.

But just before we move on, I’ll just jump in. There’s one cover to that. That also emphasises the importance of sponsors having accurate customer lists because, again, once we've agreed the action with you, and you distribute the customer letter, that is going out to your customer base. So, all customers, whether they’re a public or private facility, should be receiving that customer letter from you within those couple of days after you've received the agreement letter from us to proceed with the action.

SB    Okay. How can we ensure that sponsors who think their actions fall under product notifications, but they actually fall under a market action, do not proceed with the product notification pathway accidentally?

JC    If you're submitting an action via the TBS Portal, which is how all actions should be submitted by sponsors, there will not be an option for product notification anymore. There will only be the four market actions, those being, again, recall, product alert, product correction, and quarantine.

00:54:08

If you were, for example, to put an action in before 5th March as a product notification, again, the final assessment comes down to the TGA Recalls Section. So, if we don't believe that it would fall under the product notification pathway, then we would not proceed it as one.

NC    I would add as well that if the question-asker is wondering whether or not an action a sponsor undertakes, a product notification, is not reported to the TGA, but it should have in fact been done so, we do have pharmacovigilance programs which are keeping an eye on those things. We receive reports from the healthcare sector if they receive an action that doesn't have TGA approval or a nice RC number at the top.

So we're trusting industry. Because of these low-risk problems, we're trying to reduce regulatory burden. But also, of course, if we do believe that it becomes, or we start to notice a trend that the sponsors are undertaking product notifications without reporting them to us, but they should have in fact, they were a recall action, we will review our guidance.

CD   And importantly, to remember that as a non-recall action, under the current URPTG, by definition a product notification is a non-safety related matter. So there's a fairly clear distinction there as well. And of course, when sponsors do notify through the portal, either currently or in the future, it is often subject to negotiation.

00:55:43

You may propose one type of action, but then once our recall coordinators have assessed the action, they might consider that a different type of action is required. And then, of course, that's when we would engage in some negotiation and discussion with you on the most appropriate action type for the problem you're reporting.

SB    Will TGA take any action on customers that don't respond to recall notifications repeatedly? Are the sponsors obliged to contact such customers over phone or via a site visit every time?

JC    No. The TGA regulates the therapeutic goods industry. We do not regulate whether or not customers respond to your communications. We do recommend that you contact your customers through various means. So, that could be through email and then email reply. That could be through responding to one of our QR e-surveys that I mentioned earlier. And if that fails, then yes, phone calls and potentially site visits. As for every time, by all means, try and get a response by email.

SB    Okay. More details on the requirement of the Australian government for consumer safety. Who exactly is this about overseas supply? How do we notify them? What information is required? Or at least, please provide a link.

CD    I'll jump into that one. We've deliberately kept it generic like that, because through passage of various governments, as you will know, that prime ministers will rearrange their ministerial portfolios. Then, if there's a change of government, there will be different ministers. So we don't specifically call them out, or what department reports to them.

00:57:42

But what we can say is, typically the Australian Minister for Consumer Affairs is the minister that has oversight responsibility of the Australian Competition and Consumer Commission. Now, over the years, that has usually been, my understanding, if not the Treasurer, the Assistant Treasurer of the Commonwealth. The information would be available through Google searches to establish who has ministerial responsibility for the ACCC. That's the minister you're looking for.

SB   The PRAC states, if the therapeutic good is also a consumer good, you must notify the ACCC within 2 days of beginning your action. Please clarify when the ACCC is required to be notified. For example, an S4 medicine is a consumer good. Would this need to be notified to the ACCC?

JC   So, we state in the PRAC and the URPTG that if your therapeutic good is also a consumer good, then, yes, within two days of commencing the recall action, as approved by the TGA, you will need to notify the ACCC. I will just briefly reiterate what the URPTG and the PRAC say about what a consumer good is or is not. So, Australian consumer law defines consumer goods as goods intended to be used, or are of a kind likely to be used, for personal, domestic, or household use or consumption.

CD   So the answer to, if you were recalling a Schedule 4 medicine, yes, you should be notifying the ACCC of that.

00:59:36

Now, practically speaking, from our liaison and working closely with them in refining these processes, they then won't go and initiate an additional recall, knowing the TGA’s the regulator responsible for therapeutic goods. 

Once they're satisfied that a recall in the market is occurring, they will leave it at that. They will most likely publish some kind notification on their website, but the for the majority of information, they will now link to the SARA database, or what will become known as the DRAC database.

SB   Thank you. Is an email delivery and read receipt sufficient response of a customer being aware of the action or their response?

NC    I can speak to this one if you'd like. We've received this question a few times as well. Typically, the answer is no. There's a lot of times where people will click on an email and open it and not read the content. It doesn't give us any assurance, particularly if the customer letter is regarding a recall, or that the customer needs to undertake an action, such as correct the goods, or they need to be aware, read some further instructions in the IFU or in the product information.

Just by getting a read receipt doesn't give us that assurance. So, unless you're really, really struggling to reach your customers, in the first instance, we would recommend multiple, multiple attempts, multiple methods. If you can show us evidence that you are having trouble still reaching some non-responders, that can often be the case for very significant actions, consumer level actions, where you might be trying to contact 2,000 patients.

01:01:23

We might take that into account, of read receipts, to assist in us closing out the action, to show as further justification that you have tried to reach customers. But in the first instance, the answer would be no.

SB       Thank you, Nathan. Sponsors do have customer lists. So, this is along the same lines, I believe. Sponsors do have customer lists. However, this will be the payer, or generally the purchasing department. Knowing who the hospital recall coordinator is, is very difficult to find. So, is a notification to the payer or purchasing department acceptable to notify the action?

JC     Well, typically, we would expect a response from the customer. So, if you were to send it to, for example, the payer, it will be expected then that the payer passes it on to the responsible person for notifying, for example, the clinicians, the surgeons, whoever might be involved within the recall action, and then acknowledgement from those areas back to you. And then you can consider that an acceptable evidence of the action being notified to that customer.

NC     It can be helpful to make sure that your letter is addressed, your recall letter, to the responsible person. So, if you want it to be the head of nuclear medicine at the hospital, you can say, to the head of nuclear medicine. If your contact details, if you're finding that they aren't sufficient because, as you said, it's to the purchasing department or so on, see if hopefully you have a contact number and you can call and maybe find out who's the appropriate area to send it to as well.

01:02:59

I know it can be difficult to get responses from some customers, but we do expect, because these are safety related recall actions, that sponsors do their due diligence to make sure that it reaches the right area.

SB     Is event in the URPTG the same thing as problem in PRAC?

JC    I'm not quite clear on what the question asker is asking specifically. Adverse event, potentially?

CD    I assume the word event or adverse event is somewhere in the URPTG.

SB     I think it might be event or issue, is it the same as the word problem, is the way I interpret it sorry.

JC     No worries. Thanks very much, Sharon. Yes. So, as part of the PRAC, we wanted to really streamline not just the terminology of the recall actions, but also the language that we use within the document itself. So, previously, where a reader of the URPTG might have become confused by this issue, this event, this problem, we've now just lumped it all into problem. So, to answer the question, yes.

SB     I think you might have answered this, but we'll just go over it again. With the removal of product notification and product withdrawal from PRAC, and URPTG to be removed from the 5th of March, where will these definitions be referenced, or will these actions be made obsolete, and hence no actions or options for sponsors to take?

01:04:41

JC      Yes. So, with the implementation of the PRAC on 5th March, next month, there will be no option to submit product withdrawals or product modifications to the TGA Recalls Section. Again, if you're updating your product dossiers or other actions, other areas of the TGA may need to be notified. However, [re-reading question] ‘and hence no actions or options for sponsors to take’ For something like a product notification, if you believe it's an edge case, I always look at the EPs to see if potentially a product alert would be required.

NC    And in terms of where will these definitions be referenced, yes, they won't be referenced in any of our current guidance in the PRAC anywhere. You'll still be able to find copies of the old guidance, if you wish, for reference purposes, the URPTG on Trove, which is the place where a lot of government guidance is stored.

CD      And just on that, we don't anticipate that having any impact on you at all. Out of approximately 800 recall actions we do on average each year, product notifications and product withdrawals have been a very small percentage, I'm literally saying a handful. So, they were categories that were rarely, if ever, used or availed to by industry.

My understanding is that they were in the URPTG for many years. My understanding is they were more put in there as a service, that if sponsors were wanting to communicate a non-safety related action about some kind of notification, or if they were withdrawing a product from supply, they could avail themselves to communicate that, essentially, using the recall process.

01:06:41

But as I said, they've hardly been used over the years, so they're redundant. We're removing them. But, of course, as always, if in doubt, if you have a problem or if you think it's an issue rather than a problem, and you're not sure what to do, please always reach out to us. We're happy to have a chat and have a look at what you have and have a discussion with you.

SB   Radiopharmaceuticals are listed under immediate actions. This could be interpreted to mean that any action involving a radiopharmaceutical is an immediate action. However, some quality defects are not detected until after batch expiry, and do not meet the intent of immediate recalls. Can you please clarify?

NC      I can jump in here. Yes, sure. So, radiopharmaceuticals, bloods, clinical trials, and a few others, they're all included under that immediate recall action because of the use case of that type of product. Also because of the short half-life for the product. I do understand that if something is detected after the product's expired, after it's been used, we still like it to be included under the immediate recall pathway, because it might be important for the end user, the customer, to be aware of that as soon as possible, particularly considering radiopharmaceuticals, their use. If you're unsure, if you find something weeks after the fact, that there was a labelling error or something like that, feel free to always pick up the phone and call us.

01:08:18

There might also be some confusion that immediate recall action doesn't necessarily mean that it's class one urgent risk. It means that because of the tight controls around, say, clinical trials, or the nature of radiopharmaceuticals being compounded in the morning and supplied to a patient for injection at 9 a.m. that day, that we were happy for sponsors to go ahead and undertake the action immediately.

If you are aware that that's not the case, that the product's already been used, feel free to pick up the phone and we can discuss maybe having it go through the normal BAU route.

SB    Medical devices come with inherent base safety risks. If a field action is taken to correct a device that falls within accepted parameters of safety risk, as established in the EP, gaining certificates, a certification, does the action still need to be reported as it is an i

NCremental, continuous improvement?

NC     What I gather from this question is they’re saying that if the update is still within the risk, say it's a significantly high-risk device, and therefore it has a high margin of potential safety risks, ultimately, if you're correcting a defect to do with the device, it should still be notified to us, even if the device has such a higher margin of safety risk that it shouldn't be recalled, that's when we discuss other options like putting out a product alert, rather than recalling the device, if it's still beneficial for it to be out there with that defect.

01:10:07

But ultimately, if you're making a change to a product, if you have to correct something due to a deficiency, safety, quality, efficacy, and so on, you should still be notifying us.

SB   Okay. Is GS1 subscription mandated for recall purposes?

CD   No. Having said that. We are aware that there might be individual requirements imposed under procurement arrangements in some states and territories. We know in Victoria they have some specific requirements around use of the GS1 platform. But from the Commonwealth perspective and your interactions with us and managing recalls, no, it’s not mandated from our perspective.

SB     Thank you. Is website considered to be one of the DD methods?

JC   Not quite clear what DD method is. Distribution?

SB   Maybe we’ll take the one on notice.

JC   Yes. Yes.

SB   Perfect.

CD   We’ll talk to Naren offline on that one, DD. Sorry.

SB   Don’t know what that means. Yes. Oh, hold on. Sorry. My bad. Will you avoid using the term recall generically for everything to align with the new market action nomenclature?

01:11:32

JC   Yes, we will. Certainly, I speak personally, that old habits die hard. But, yes, in our communications, we will be using the market action nomenclature.

SB   Do class I and III also require same level of due diligence, or can they be agreed upon at the start of the recall?

JC   Due diligence?

NC   Uncertain exactly what you mean by the due diligence there, and can that be agreed on at the start of the recall? If they mean the reporting requirements, that maybe there might be higher levels of reporting requirements for higher risk or more follow-up required to customers, we may be able to agree to that at the start of the action.

Again, typically speaking, we've still kept in the requirement for there to be reporting and follow-up due diligence for class II and class III actions. But again, a very low risk class III action, we might only require one report or less customer follow-up, especially if, for instance, you can show that the action, that there is no longer any risk to customers.

For instance, if it was, say, a software update required to a system, but you can do that remotely at the customer site, and then you're still having trouble getting an acknowledgement from some hospitals, but you've already fixed the problem for them, we might be more willing to accept a lower response rate or lower due diligence in following up with them, if you can show that the risk is mitigated.

01:13:08

CD  But in terms of due diligence in conducting the market action itself, yes, I would say that there's no difference, apart from the classification that we will agree to. By definition, class III is low or negligible hazard or risk of harm or injury. Class II actions can be quite serious and involve injury or patient harm. So, a high degree of due diligence is required in terms of managing the action and ensuring it's undertaken effectively and in a timely manner.

JC Just for the note of time, we have, I believe, ten minutes remaining.

SB  Okay. Thanks, Jack. With the update to the TGA eBS Recall Notification portal, can the character limits for the fields, such as problem description, device details, model numbers, etc, be expanded?

JC   Short answer, we've looked into it. Some fields, yes. Other fields are linked to hardcoded elements in our RAMP system, and so could not be updated. As soon as you try and save or verify the submission as you're writing it, it will tell you if you're over or under. At the top of my head, I can't tell you which were able to be expanded. I may need to take that on notice.

NC   I can remember a couple. ‘Product Description’ was one of the fields that we expanded from 1,000 characters to 1,500. I believe ‘Problem Description’ was the other one that we expanded from 1,000 to 1,500. Going beyond that, we did have, as Jack said, IT limitations, and also having that information be able to sync to the public database, the DRAC database, beyond that. So there are still limitations, but we did take that feedback from the consultation and updated some of them.

01:15:05

JC   Yes, which we’ll later tie into the wider TGA transformation things. That's not within our timeline for the PRAC, but as our systems are modernised, you'll see those fields expand eventually when we move to the newer platforms.

SB  Health care professionals being made aware of the updates to PRAC with the new market terminology?

JC  So, we've been routinely updating key stakeholders about the different updates. So, from the URPTG version 2.4, telling them about our GMP Forum presentations, and I believe also the release of the PRAC. So, yes, healthcare professionals should be aware of this update, and we'll continue updating our stakeholders.

SB    Okay. For class I market actions, do you now have to include the word critical in the title of the letter, e.g., critical product defect correction, versus urgent product correction for class II actions?

JC   Yes. You will. For all class I market actions, in your letters, you will need to title them with the word critical. For class II, it will be urgent, and class III does not require any sort of prefix.

NC   This ties back to one of the previous questions about recall fatigue for customers in the market.

01:16:34

We were finding that people were starting to see urgent recall letter, and even though that was right there in the title, they might not really understand what the risk was. So we wanted to put in that extra level of highlighting for class I actions.

SB  Awesome. Hold on. Can the TGA provide examples on the website for each of the type of market actions to help with a common approach?

JC  I believe the actual section in the PRAC, if that question asker brings up the document, you will see that there are examples provided that will tell you when an action is or is not appropriate. As for hard examples, again, we did wish to move away from this, because ultimately, you should know what will best resolve your problem. And so, to sort of have to reverse engineer it from a document from the TGA could be counterintuitive and ultimately delay the time it takes for you to submit a notification to us.

CD  Looking at the actions we publish on the SARA database might give you some guidance in that regard, give you examples of the different types of actions and reasons for those actions.

SB  A burning question. Are you going to change the name of your department from Recalls to Market Action?

JC  And then be called the Market Actions Department with the acronym MAD? At our level within the organisation, the teams are grouped into, what would you call them, collections called sections. So, we're currently the Recalls Section, and I don't believe we have any plans to change that name.

01:18:23

SB   Given the time that's left, I'm just going to have this last question, just noting that all the other questions will be taken on notice, and we can provide feedback. Can the TGA work with authority responsible for managing healthcare facilities to help with better response rate and educate the importance of why response is required?

CD   No, not directly. The TGA is an agency of the Commonwealth. We do not have jurisdictional authority over state, territory healthcare facilities. They fall under the responsibility of state, territory health departments. But if there are any specific problems or concerns, as you know, we have the state and territory recall coordinator network, and we can and do work closely with them on an as needed basis on individual cases, as required. And they can certainly provide some assistance in that regard if we need to.

JC Perfect. Thank you.

SB Awesome. Okay, so that was the last question. I'll hand back to the panel.

JC Just for everyone who's attending, I just want to say, as a final note, between now and 5th March, Nathan and I will be working alongside other members of the Recalls team to test our IT updates to ensure that the transition on 5th March goes seamlessly.

01:19:53

The Recalls inbox, as noted, remains open, should you have any additional questions that you wish to ask. And finally, personally, I'm really glad that you're all here. By being here, you've demonstrated the same understanding as Nathan, Craig, myself, and really everyone at the TGA has about the reforms program, that understanding being that the relationship between industry and regulator is a very important thing.

This talk has imparted you with the key points that we believed you needed to know about the PRAC before it takes effect. And when it does, I want you to know that your feedback throughout the years has been crucial in getting our procedure to this point. I think we can all now suggest that you go and read the PRAC. We might be biased, but we all think it's a good read.

01:20:43