Meeting Your Obligations

Avi Rebera: Good afternoon everybody. My name is Avi Rebera, and I'd like to welcome you to the SME Assist 'Meeting Your Obligations' Workshop.
Before we continue, I would like to acknowledge the traditional owners of the land on which I'm presenting from here today, the Ngunnawal people, and I'd like to pay my respects to their Elders past, present and emerging. And I'd also like to welcome any Aboriginal and Torres Strait Islander people that might be joining us here today.

Slide 1

Before we get going with the workshop today, I would like to make a disclaimer. As all things government, we tend to have a disclaimer for most things that we do. Just be aware that the presentation and the workshop and the slides today are here for general information. It is not providing you any specific advice in relation to any product that you may have, and certainly please do not take any of this as being given approval to provide or supply a product here in Australia. Any assessments that we do will be based on specific applications that you put to the TGA, and we will make any determination or decision at that point in time.

Slide 2

So for today's workshop, the way we're going to do this is I will be running through some basics to do with therapeutic goods regulation, just to give you an overview of the system. My colleagues will then be presenting some case studies that take what I've presented on, and actually then give some tangible examples around that.

At that point in time, at the end of those case studies, we will be stopping for a half an hour break and then coming back at 3:30. One of the things you will have noted when you registered is that there is a separate link for the Q&A session. And because we are using a separate link, I do ask that you try to hold your questions that you type in through Webex, through the webinar system, from this session to the next session so that we can pick up the questions in that session and be able to answer them. If you do have a burning question, please send it through now, but our preference would be for you to do it on the link in the Q&A session. And then that should finish by about 4:30. We'll wrap that up. And also we are recording this session as well.

Slide 3

So what is SME Assist? So SME Assist is a service that we've set up at the TGA to actually provide targeted support to any organisation or individual that is not just an SME, but anyone who is also unfamiliar with therapeutic goods regulation. You might be looking at bringing a product in to the market for the very first time. And so this provides you with some entry level guidance on what it is you need to do as what we would call a sponsor, and within that we have material that you can use in terms of access to these workshops. We have webinars, we have pre recorded webinars, and we have a whole series of online materials that will actually support you. We also have phone and email support, because we know it can be difficult for you to actually get access to a specialist or an individual at the TGA. So through the SME Assist team, if you can send us your questions, then we can help try to find answers and link you up with the necessary experts within our organisation as well.

We also have a subscription service. So go on to the TGA website to SME Assist, and if you subscribe, we do push messages out to you or when we're running other workshops or particular seminars or those new tools that we put up on the website as well. So I certainly encourage all of you to go and do that.

Slide 4

So what are the objectives for this afternoon? So firstly, as I said, I'm going to give you an overview of therapeutic goods regulation. We're also going to provide you information on the TGA SME Assist service. I'm going to give you some links that are helpful in terms of how to navigate through out website and find relevant information for your product, and also some other useful links in terms of when you're ready to apply to the TGA for authorisation or approval.

Slide 5

So now I'm just going to run through the basics of therapeutic goods regulation. It is going to be very high level, but there will be some links available to you, and through the case studies you'll be able to get a bit more information as well.

Slide 6

So in terms of therapeutic goods, everyone at some point in time is very likely to interact with a medicine or a medical device. And so it ranges from you being a consumer through to either being a wholesaler, a retailer or a sponsor of a product. In terms of what we're going to go through today, just those areas that have just been circled in yellow are the areas that we're going to be focusing on for today's workshop.

Slide 7

So what is the role of the TGA? So we regulate and monitor all therapeutic goods in Australia to make sure that they're safe to use and do what they're actually intended to do. And this is mandated to us through the Therapeutic Goods Act, and there's some underlying regulations that also apply to that.

Now one of the things I will highlight as I run through these slides, is you'll see a little information sign somewhere on the slide. If you click on that sign within that slide and you've got the presentations, it will actually take you to the relevant pages on our website for the particular topic that's on that slide. So for example, this would take you through to the Therapeutic Goods Act so that you've got a quick easy reference into that. So just remember that as I go through the slides, and as my colleagues will as well.

Slide 8

So I'm going to run through a little video and just play this for you all now. Understand that my marketing guys love it. They want me to show it. But it does have an underlying meaning, and I'll talk about that in a minute once the video's gone through.

Voiceover: On any given day, our work benefits the health and wellbeing of every Australian. When using vitamins or medicines, or receiving a cutting edge medical treatment, we are here to make sure health products are safe for you to use. Whether you need a transplant or an implant, need a blood transfusion or a vaccine, whether you're creating life or living life to the full, we make sure products are safe, high quality and do what they're supposed to. We keep an eye on medicines, and if we find a problem, we'll tell you. It's nice to know that someone's looking out for you to help you get well and stay well, because we're for the better health and wellbeing of all Australians through regulatory excellence. We are the Therapeutic Goods Administration.

Slide 9

Alright. Now the reason I really like to actually play that video is for it to highlight what it is we do. And at the TGA, our focus is around safety, and it is around that efficacy piece. But our focus is on ensuring that the medicines and the therapeutic goods, the medical devices that we do approve, the Australian public can take a level of comfort knowing that we have made those assessments, and that we do have the public and we do have patients in mind when we are actually looking at therapeutic goods and their ability to be supplied here in Australia.

So what is it that we regulate from a therapeutic good purpose? Well it's anything that fits broadly within these definitions around preventing, diagnosing and curing, influencing, inhibiting or modifying a physiological process, something that does testing on a person for a disease or an ailment, something that might influence, control or prevent conception, testing for pregnancy, and replacing or modifying any part of the human anatomy. So they're the types of things that we actually regulate when it comes to looking at what is a therapeutic good, and again, the definitions of that sit within our Act and also on our website.

Slide 10

So when we do talk about a therapeutic good, we broadly class them into three areas in terms of the terminology that we use at the TGA, and that is under medicines, biologicals and medical devices. So in terms of medicines, these include prescription medicines, complementary medicines, like certain vitamins for example, over the counter medicines – so they're the ones you can buy at a pharmacy, either behind the counter or on the shelves – vaccines, blood and plasma products as well we consider under medicines.

Slide 11

Under biologicals, they're things that are made from or contain human cells or tissues, or even live animal cells, tissues or organs.

Slide 12

Medical devices. These are generally ones that have a physical or a mechanical effect on the body, or are used to measure or monitor functions within the body itself. Include things like instruments and appliances and other materials. One of the things to understand too with the TGA is often if there is a therapeutic good that doesn't fit nicely within either the medicines or the biological definitions, then you might find it actually sits within a medical device space. And a good example of that is certain disinfectants, hospital grade disinfectants and so forth, that we would actually classify under the medical devices, because it doesn't necessarily fit in the other two areas.

Slide 13

So what are some of the things that we don't actually regulate? We don't regulate veterinary medicines. We do not regulate health professionals or health insurance. We don't look at the food standards. And that's a little bit different. There are some other regulators in other countries that look at therapeutic goods as well as food. We don't do that here in Australia. And we don't do cosmetics and chemicals. And by cosmetics, I mean the general cosmetics, certainly not some of the cosmetics that are used in surgery, so cosmetic surgery products. Those we do. So on the slide here it generally highlights who has responsibility in terms of the Federal Government for those particular areas. One of the interesting things that you will need to pay attention to is the jurisdictions also have regulations in terms of therapeutic goods, in particular some of the supply requirements around those. So if you are going into this space for the first time, be aware that you will also need to understand what might be happening in any particular jurisdiction that you're also supplying the product. And for that you'll need to contact the state and territory health departments to get further information on that.

Slide 14

So what are some of the other things that we don't actually look after? So we don't look at research and development. We're not involved in research and development of therapeutic goods. We certainly don't provide clinical advice to individuals. We do get questions on a daily basis on recommending medicines, one over the other. Once the medicine is approved, we do not recommend any medicine in terms of one versus the other one. We don't look at the cost effectiveness of a particular product. So the fact that the Therapeutic Goods Administration might approve a product, does not necessarily mean it is commercially viable. That is not something we look at in terms of when we're approving it. And we certainly do not make any decisions around subsidy, so whether a product gets added to any PBS listing. While that is done by the department, it is not something that's done specifically by the TGA. We do however work in parallel, and there are opportunities to look at how applications can go through in parallel as well.

Slide 15

Before I get into more detail around some of the terminology we use, I just thought I'd highlight roughly a few things that have happened in terms of COVID-19 and Coronavirus. So we all know that the first cases happened in Australia in late January 2020, and it was certainly something as a regulator that we had to respond to fairly quickly to ensure that the safety of Australians could be managed as well through this process. There's some statistics on those slides around some of the work that we did, but we certainly saw a huge volume in work coming through, because as a general rule, hand sanitisers to some extent, but your personal protective equipment, face masks and the like, all needed to come through the TGA to get approval before they could be supplied here in Australia. So one of the things to remember if you are joining us today and you are looking at therapeutic goods in response to the pandemic and COVID-19, is that your product may well be captured by the Therapeutic Goods Act, and therefore you will need to come through us to actually get approval to be able to supply that product here in Australia.

Slide 16

There are some exemptions that we did put in place in terms of hand sanitisers, and so again, if you check the Therapeutic Goods website, you'll be able to get advice on that as to whether your product, if you are supplying one of those, falls in under the Therapeutic Goods Act, or in fact for some hand sanitisers, if it's not under our Act, then you could actually fall in under the ACCC as well. So make sure you get an understanding of that. And at the bottom of this slide is the little information sign for you to click on to take you on to further information on that.

Slide 17

So in terms of the therapeutic goods life cycle, I've just put this up so that you can see actually when it is that the TGA gets involved in the process in the life cycle. Early clinical trials is an area where we don't actually get involved in at all, but it's something that you need to be aware of when you're doing clinical trials, will be around the types of things that we require from an evidence and an application process so that you're prepared for when you do provide us with an application.

Again at the other end, as I said earlier, on the subsidy side, the TGA does not get involved in the subsidy piece, however it is part of the broader Department of Health work and there will be some overlap in terms of the evidence that you need to provide, both to us and the Pharmaceutical Benefits Advisory Committee as well, if you're looking at subsidy.

Slide 18

So in terms of clinical trials, as I said, we don't get involved, certainly in the early stages. Once you start looking at human clinical trials, then there are two application processes that you do need to provide through to the TGA. The first one is a CTN, which is your Clinical Trial Notification process. That tends to be for lower risk medicines, and that's a fairly straight through process on that. Where you've got higher risk or more complex drugs that you're looking at, you will need to send an application through to us, and that's known as CTA, or Clinical Trial Applications. For those of you who do have a bit of familiarity with this process, CTA is a fairly new terminology for us. We used to call it CTX, and it was known as Clinical Trial Exemption. However the fact that you needed an application made it very confusing using exemption, so we've actually just changed that terminology.

Really the important things to understand with clinical trials is that while we don't play a big part in it, you do need to make sure that those clinical trials are set up correctly in accordance with the International Council for Harmonisation of Technical Requirements, and also that you actually have a human research ethics committee set up as well.

Slide 19

So this table at a high level shows you the responsibilities of the various areas. The sponsor has overall responsibility, but certainly please make sure that when you are setting up your clinical trials that you do it in accordance with the requirements here in Australia, because this is about – certainly when you're getting into human clinical trials – testing an unapproved therapeutic good.

Slide 20

So more information can be found on our website. There is a link again on this slide to take you to the Australian Clinical Trials Handbook, and that will give you information on that. You can also go to the NHMRC website, and they will actually provide further details in regards to clinical trials. I believe they have a separate website for that as well.

Slide 21

So again, if we go back to our life cycle, therapeutic goods life cycle, the main areas where you will be interacting with the TGA is in what we call pre-market, processing and post-market. So I'm just going to run through a little bit of that now.

Slide 22

In terms of what we define in those spaces. So pre market is where we actually look at the market authorisation, and where we go through the process for you to get approval for your product. Now when we provide approval, that approval is for you to supply that product and that therapeutic good here in Australia. And what we mean by supply is sale, exchange, gift, loan, hire or hire purchase. So if you're doing any of these following functions in terms of manufacturing, importing, exporting, or even arranging for the import or export, then that could fall in under the definition of supply, and then you will be captured by the Therapeutic Goods Act, and you will need to seek market authorisation.

An important thing to understand here too is even if your intent is to supply the product for free and there's no charge, you will still fall in under the Therapeutic Goods Act, and you will need to get market authorisation from us.

Slide 23

So once you've obtained market authorisation, you become known as the sponsor. And as the sponsor, you bear all the associated responsibilities for the supply of that product here in Australia, and that's irrespective of where in the supply chain you might be. So for example, if you are importing a product from overseas for supply in Australia and there might be a manufacturing issue overseas, you as the sponsor can't devolve yourself of responsibility by saying the manufacturer overseas made an error or made a mistake. In Australia, we would still hold you responsible for the supply of the good here, and it's your responsibility to ensure that the supply stays safe or there's recall requirements in there as well.

So also understand that as a sponsor, even after you cancel a product on the ARTG, if there is still supply here in the marketplace, your responsibilities don't end just because you've cancelled as a sponsor.

Slide 24

So in terms of your application to become a sponsor and to get market authorisation, we have established agreements with overseas regulators as well so that any assessments that have been done overseas can be taken into consideration when we make a decision here in Australia. And depending on whether you have a medicine or a device will depend on what sort of overseas comparable assessments we will accept. And there will be more on that a little bit later on in the case studies as well. The important thing again to understand with this slide though, is while you might have approval from a country overseas, it does not mean you will get automatic approval here in Australia. We will still go through our assessment process and provide you with approval. So don't make the assumption that approval overseas is automatic approval here in Australia as well.

Slide 25

Once your product is approved, then it will go on to the Australian Register of Therapeutic Goods, or the ARTG. And that's a register that is available to the public, and it provides general information on the products such as the sponsor details, what are the active ingredients, the classification, who the manufacturer is and so forth. And all of these entries are under the sponsor's name. So if you're developing a product for the first time, you might want to actually have a look at the ARTG just to check and see if there are similar products on the ARTG to your product. And that will give you an indication of where that might sit in terms of access, is it a prescription medicine that's up there, what class of device it might be, and that might help you with your application process as well.

Slide 26

So one of the things in regards to entry on the ARTG is that every product listed on there has to be separate and distinct. And that has different meanings, whether you've got a medicine or a device. And as this table highlights, and if you use those links, it will actually take you to the relevant definitions within our Act and our Regulations as to what we mean by separate and distinct. So one of the things to understand is that for devices for example, you can classify and group certain devices to be separate and distinct, but with medicines, generally each individual medicine, even if they're similar, would need to be classified separately and have separate ARTG entries on that.

Slide 27

So I'm just going to run through now a little bit of an example around how that works in practice with regards to being separate and distinct. So in this example we have John, and John has applied to the TGA to be a sponsor of a particular product, and he gets approval, market authorisation, and an ARTG entry for that product. Anna has decided that she would also like to supply that product here in Australia, and so she has a number of options available to her. Firstly she can go to John and ask John if she could be a retailer and sell that product on his behalf, and that would be an agreement that they would need to come to in their own right. It's not something that we would look at.

The other option is that Anna could decide that she would like to supply that product herself as a sponsor, and she could apply to the TGA to get market authorisation to do that. But she would not be allowed to do that if she was using the same name and the same packaging and nothing was changed or different. At minimum she would need to look at actually changing the name of that product or that medicine in order to be able to supply that and to get her own market authorisation as well.

Slide 28

So in terms of what are the things that we look at when we are approving a particular product, at a high level the thing to understand is that we actually look at the benefit versus the risk in terms of the product that you're asking for approval for. And really, the way we use the risk model is depending on what we think higher risk products require, you will require more evidence, you will require more data, and it will need to go through a more robust assessment process before we can actually approve it. And fundamentally what we look at is do the benefits outweigh the risks. We acknowledge that not all medicines are safe. So for us to just look at a safety profile is not what we look at. There are a number of drugs, in particular when you look at some of the cancer drugs, that do pose significant risk to patients, however a lot of those drugs and the ones that we approve, the benefit outweighs those risks. And in those scenarios, we're still looking at the approval and market authorisation for those. And that's a really good example of where the benefit and the risk profiles, even though the risk might be high, could still get market authorisation in order to be able to supply the product here in Australia.

Slide 29

In terms of medicines, broadly they can be categorised from a risk perspective into three areas, listed, assessed listed and registered products. The listed are the lowest risk. They're generally the ones that get assessed very quickly. It's a fairly straight through process. We don't do any pre market evaluation of those applications. There are strict parameters around that. There are only certain indications that you can provide those products under, and they have to have low level ingredients in terms of risk. And there's a list of permissible ingredients that can be used, and it's fairly well defined in that. We do require good manufacturing practice approval. It is required as part of the pre-approval process. But that's something you need to hold in case we ask for that as well, and you need to provide evidence on that.

As you move up into the listed assessed, we do have a bit more overview over that, and we do assess parts of that. But again, there's some parameters around that that make that process a little bit easier. All the way up to a registered product, where we will go through a full pre-market evaluation, and we will need that evidence and that data as well. And it may contain some quite significant and harmful substances in those as well. And as we go through that, the fees and charges change, and I'll touch on that a little bit later.

Slide 30

Again, if we take it form a different perspective and look at the benefits versus risk, prescriptions medicines, they're always going to be a registered medicine, and you will need an AUST R number on those. Over the counter medicines, some of them could be as listed all the way through to registered medicines as well. Your complementary medicines are predominantly on that listed side. Some of them could move up into your assessed listed or your registered, and again, very often that will depend on the indication and what it is you're actually stating that that medicine is there to treat.

Slide 31

So devices is very similar. So if you've got a medical device, again they're based on the risk, starting with your Class 1 devices, which are a much lower risk, all the way through to Class 3 and your active implantable devices that are much higher in terms of the risk, and therefore again from an assessment perspective, we're going to require more evidence and more data on that. Similarly, IVDs also have their risk classifications as well, and on that slide at the very bottom there's a link if you want to understand what the IVD classifications and the risk models are for those products as well.

Slide 32

So one of the important things to understand with the TGA is that once we give you market authorisation, once we give you approval, our regulatory work does not end. We continue to actively monitor products that are out in the marketplace. So all the way from manufacturing through to what's happening in the market, what's happening in Australia, any adverse events that might be occurring, we're also monitoring that aspect of it. So that whole supply chain, while products are available here in Australia, we continue to play an active role in regulating those products in the marketplace here in Australia.

Slide 33

So in terms of how we manage the compliance, where we might find that there are issues with compliance for a particular sponsor or a particular product, again with compliance we take a risk approach, and the risk approach we take is proportionate to the issues that we're facing. If it's a minor compliance issue, it might be the first time for a sponsor, or it's something that can be easily resolved, we like to look at education and guidance to help the sponsor understand why there might have been an issue, through to resolving it and making sure that it doesn't happen again. More serious compliance issues, or where we might have repeat offenders or those sponsors that actually don't want to comply and continue to not comply with the requirements under our Act, we can go all the way up to criminal prosecution. But again, we don't like to do that. We do prefer to work with sponsors. But it doesn't mean that we won't take swift action. And those of you who might have been monitoring the TGA Facebook posts might have seen that there were a number of infringements issued during COVID for practices that were not compliant with the Therapeutic Goods Act, and we felt were serious enough, sometimes even for first time offenders, to warrant taking action beyond education and guidance as well.

Slide 34

So now I just want to throw over and talk about a few of the helpful links in terms of what you might actually need in terms of reference and resource materials for putting an application in to us. We have what is known as the Australian Regulatory Guidelines, and that is broken down by product and type of product so that you can easily find what it is you need. So from complementary medicines, over the counter, prescription medicines, medical devices and biologicals, those are the links to actually go look at that. That's a really good starting point from a guidance perspective around what it is we require in terms of data and evidence for when you provide an application to us.

Slide 35

You'll also notice there that we've got sunscreens and advertising. We have sunscreens separately, because that is a fairly technical complex area, and spans across the work the TGA does as well as other regulators as well. And advertising is there separately, and my colleagues will run through some examples around advertising. We've got a new advertising code as well, so it is important to understand that as a sponsor you do have obligations with regards to advertising, in particular now with social media as well. But we'll go into a bit more detail on that. But please make sure you're familiar with that through the links on that page.

Slide 36

So that's a visual of where you'll find the guidelines. It's under the 'Industry' tab on the TGA home page, and then if you go in to prescription medicines for example, you can see standards and guidelines, and similar for the over the counter, sunscreens, biologicals, etcetera as well.

Slide 37

So some of the other guidelines that will be useful to you are things like the medical device cybersecurity guidance, if you're in that area, understanding who our comparable overseas regulators are that I mentioned earlier, both for devices and also for medicines. Again, the advertising guidance for businesses, involved with stem cells, and then research considerations as well for medical devices. So they're some other useful links that you can use at any time.

Slide 38

So the key area that you will actually interact with the TGA is through what is known as the Business Services portal, and that can be found in the 'About the TGA' tab on the website. And there's some instructions there around how to do it.

Slide 39

This portal is where you will actually go to provide an application for market authorisation. It's also where you need to set yourself up to become a sponsor. So you have to register as a sponsor with us, or register with us to be able to use this portal as well.

Slide 40

And that's where we'll get some initial information from you as well. But you will use it as the main point of interacting with us here at the TGA. So as I said, market authorisation, clinical trial notifications will come through there, advice on adverse events. It's also where you'll pay any invoices or pay your fees, and also keep up to date with your details. So it is an important tab within our website.

Slide 41

So generally the fees that we have are for a service. So for example, we charge a fee for applications that do come in for market authorisation, and then we do have charges which we apply annually once you have a product registered on the ARTG as well. So there's more information on that. You can use the link on the slide for that one.

Slide 42

So in terms of the fees and charges, we do have what is known as an annual charge exemption, or the ACE scheme. It does allow you to be exempt from those annual charges when you first register a product with us where it may not be generating any turnover for you. So all new entries are eligible, but once you start to make turnover and you need to make an annual declaration on this one, then you will not be exempt from the annual charges. Understand also that in future if the product did generate revenue and then is no longer generating revenue, if it has generated revenue in its lifetime, you cannot come back and get an ACE exemption again. So it's generally upfront before the product is either being supplied or generating revenue here in Australia as well.

Slide 43

So in terms of getting more information or more assistance, again, if you go to the home page, under 'Industry' there, there is an SME Assist link, and that will take you to the SME Assist web pages where you'll find a lot more information on this, links to other webinars and other useful tools that we have. Also be aware that we do have for example a decision tool on there that talks about 'Is my product even a therapeutic good?' And you can use that to run through to actually determine if you do have a therapeutic good or not.

Slide 44

If you have any other questions however, you can contact us. So we have a 1800 number there, and we have an email address that you can send it through to the dedicated team, and they'll come back and respond to you with any particular questions that you do have.

Slide 45

So on that note, I'm now going to hand over to my colleague Jane, who is actually going to start talking and taking you through some of our case studies.

Slide 46

Jayne Foster: Thanks Avi. Good afternoon everyone. I look forward to taking you through some case studies to further explain the key areas of therapeutic goods regulation.

Slide 47

So the key areas we'll look at today include market authorisation, and we'll also touch on supplying certain therapeutic goods for COVID-19, manufacturing, advertising and post-market monitoring.

Slide 48

I'll be covering therapeutic goods in general. So look out for these icons on the slides. The icon on the left represents medicines and biologicals, so when you see this icon, the information on that slide relates to both of those types of products. The icon on the right represents medical devices, and the icon on the bottom means that the content relates to all therapeutic goods. So that's medicines, biologicals and medical devices.

Slide 49

So our first stop in the regulatory maze today is market authorisation.

Slide 50

So Avi covered the therapeutic goods development life cycle, which includes market authorisation. So sponsors have numerous responsibilities at each stage of the market authorisation process. The pre-market stage is where you compile data and information relating to ingredients, manufacturing quality, and labelling and packaging. The processing stage is where you submit your online application, and attach the required data and more information if requested. You pay your application fees at this stage, and then your product is evaluated or assessed. The post-market stage is where you report adverse events and safety issues, or issues with manufacturing or ingredients, you conduct ongoing safety monitoring activities, and develop periodic safety reports and risk management plans if applicable. So this is where you need to comply with any conditions of registration, and ensure that ongoing fees and charges are paid. So remember that TGA approval does not mean that your product will be subsidised. So now let's have a look at what you need to consider in your application, so the pre market and processing stage.

Slide 51

So before you apply for market authorisation, you first have to determine whether your product is actually a therapeutic good. So TGA only regulates therapeutic goods. We don't regulate cosmetics or food. So it's important that you know what kind of product you have.

So you could search the ARTG for similar products, or you could use our decision tool, 'Is my product a therapeutic good?'. For medical devices, you can use the 'Is my product a medical device?' or 'What classification is my medical device?' decision tool. You could also ask manufacturers about similar products, and you could look at labels, instructions and advertising material.

Slide 52

So if you do identify your product is a therapeutic good, you can proceed with the market authorisation process. So you'll need to consult the Australian Regulatory Guidelines, as Avi just pointed out, to determine what's required in the application process.

So for complementary medicines, we have the ARGCM, for over the counter medicines the ARGOM, prescription medicines it's the ARGPM, and for biologicals, it's the ARGB. And for medical devices we have the ARGMD. Those purple and green boxes are links, so if you click on those throughout your slides, you'll be taken to the relevant guidance material.

Slide 53

So as Avi mentioned earlier, TGA makes use of overseas assessments where possible. So this can reduce duplication of effort where assessment has already been conducted outside Australia. We may use assessments from comparable overseas regulators and international assessment bodies in the regulation of both medicines and medical devices. So the criteria used to identify a comparable overseas regulator or an international assessment body differs, depending on the type of therapeutic good that you have. And this list is growing, so make sure you check our website regularly for the current list and for any updates. But at the end of the day, as Avi said, TGA is still the decision maker, and the comparable overseas regulator or the international body needs to meet our defined criteria and processes.

Slide 54

So when you're preparing your application for market authorisation, there are two critical areas that you need to take into consideration. Firstly, what does your product contain? This is mainly relevant to medicines and biologicals, but sometimes it's also relevant to medical devices, especially when they deliver substances as well. So the ingredients contained in your product determine how stringently it's regulated. Does it contain permissible ingredients? So this is a list of ingredients that have been deemed to be sufficiently low risk. Or does it contain substances in the Poison Standard? This is another list of ingredients that could be much higher risk.

And secondly, what claims are you making about your product? Are you intending to make a general claim, such as helps promote general health and wellbeing, or are you likely to refer to a specific disease, such as cures diabetes?

Generally we regulate a product more stringently if it contains higher risk ingredients or you're making higher level disease specific claims. So this means that you'll be required to compile and submit more data to demonstrate efficacy. But the relevant Australian Regulatory Guidelines will specify the type of information that you need to provide about your ingredients and your indications.

Slide 55

The therapeutic goods must be clearly labelled to ensure that consumers are given accurate information about your product. So for medicines and biologicals, labelling and packaging requirements depend on whether the medicine is a prescription, a non-prescription medicine, or a biological. And these requirements are set out in labelling orders, which is pieces of legislation. For medical devices, the Essential Principles specify the labelling requirements and instructions for use. The medical devices regulations specify sponsor information that needs to be included with medical devices. So the Essential Principles are a set of criteria that need to be met to demonstrate that your device is safe to use.

Slide 56

So when it comes time to submit your application, you need to log in to your TGA Business Services account. For medical devices, you need to submit your manufacturer evidence first and have that approved, before you actually make your application for market authorisation.

Slide 57

So we'll now move on to a case study. This is Alex, and she'd like to become a sponsor for a non-prescription medicine called Omega Breeze. Let's have a look at what she needs to consider when putting together her product's label.

Slide 58

So we're going to look at creating a non-prescription label using TGO 92. So this labelling order will tell us the specific information that we need to include on the label. Things such as the product name, the batch number and expiry date, storage conditions, directions for use, and the address and contact of the sponsor. It also specifies how information should be displayed, for example the required AUST L height should be greater than 1 millimetre. So it's too small on this label. If we increase the size of it, it's much clearer. Text must be clearly legible, and the label must be durable. So in this example, the use of colour behind the text makes the text difficult to see. So we would consider that a breach. Changing the colour behind it has made the text much clearer and much easier to read.

Slide 59

Our next step is to consider other legislation that might have an impact on our product's label. In this example, we'll look at the permissible ingredients determination, and we'll start by looking at a krill oil ingredient, Euphausia superba oil. We must consider if the ingredient itself has label requirements, and we do this by looking at the permissible ingredients determination. So you can see a snapshot of this determination at the top of the slide. The determination states that we need to include a warning statement, 'Contains crustacean shellfish' or 'Derived from seafood'. Looking at our label, we have already incorporated the warning 'Contains crustacean shellfish' from TGO 92. So that warning is enough to satisfy both TGO 92 and the permissible ingredients determination requirements.

Slide 60

We now need to include our indications on the label or what the product will be used for. So the use of some indications will require label statements to be included on the label. Let's look at the permitted indication 'Reduces common cold duration'. We need to check the permissible indications determination this time to check if there's any requirements associated with the use of that indication. So there's a snapshot above of the permissible indications entry. It has a few requirements for the label. We need have an 'If symptoms persist' statement, and we also need an 'Adults only' statement.

As you can see, we've added the warning to our main warning section, and we've put the 'Adults only' up near the directions of use. So that makes this label compliant. So you can see that you need to consult the relevant labelling order, as well as other relevant legislation to ensure compliance. And we haven't touched on everything in this example. There's also things like the advertising code that you'll also need to comply with. Alright. I will now hand you over to Melanie Leake in the SME Assist team who will take you through supplying certain therapeutic goods for COVID-19, as well as manufacturing.

Slide 61

Melanie Leake: Thanks Jayne. We'll now take a look at therapeutic goods for COVID-19. It's important to point out that some products for COVID-19 may or may not be considered therapeutic goods. This includes hand sanitisers, disinfectants and personal protective equipment such as face masks. In response to the COVID-19 pandemic, the TGA has excluded some products, such as certain types of hand sanitisers, from being therapeutic goods so they can be made available urgently. As the TGA only regulates therapeutic goods, it's important to know if your product is a therapeutic good or not to understand your regulatory requirements.

Slide 62

Hand sanitisers are products that contain antiseptic ingredients used on the skin to kill or prevent the growth of micro-organisms, and can be either hand washes for use with water or hand rubs for use without water. Some hand sanitisers are considered general consumer products or cosmetics, and not therapeutic goods. These include some antibacterial skin care products where claims are limited to general, low level activity against bacteria, for example kills 99.9% of bacteria. And they must not contain substances that are included in Schedules 2, 3, 4 or 8 of the Poison Standard. These products are not considered therapeutic goods and are not regulated by TGA. These products are regulated as consumer goods under Australian consumer law.

In response to COVID-19, on March 28 2020 the TGA excluded specified hand sanitisers from TGA regulation. These are known as excluded goods. These products must meet specific requirements outlined in the Therapeutic Goods Excluded Goods Hand Sanitisers Determination, or the Exclusion Determination. All hand sanitisers that are therapeutic goods must be included in the ARTG, and must meet TGA's regulatory requirements.

Slide 63

summary, hand sanitisers that are therapeutic goods must be included in the ARTG by submitting an application through TBS, along with supporting data, are regulated as over the counter medicines, and must meet all regulatory requirements for OTC medicines. The Australian Regulatory Guidelines for over the counter medicines contains all the information you will need to know about the requirements for OTC medicines, including, but not limited to, what supporting documentation you will need, such as evidence of quality and safety, what manufacturing requirements may apply, and how to have your hand sanitiser included in the ARTG. For more information you can contact the OTC medicines team at OTC.medicines@health.gov.au.

Slide 64

Due to COVID-19, there is significant interest from potential sponsors around how disinfectants are regulated, and how to supply them. Disinfectants are generally for use on hard surfaces, but not for use on the skin. What disinfectants claim to do, for example on labels, instructions for use or on promotional material, will determine how they are regulated by TGA. As indicated in this table, disinfectants can be a therapeutic good and have ongoing requirements, a general consumer product which doesn't make therapeutic claims, such as cosmetics, an exempt disinfectant which is subject to the Therapeutic Goods Act but does not need approval from the TGA prior to supply, or an excluded good.

Products for use on the skin are regulated separately. For example, antiseptics are generally regulated as over the counter medicines. Hand sanitisers may be antiseptics, but may also be cosmetics, where they only contain low risk ingredients and only make general bacterial claims. Or they may be excluded from TGA regulation, for example under the COVID-19 exemption, where they meet specified formulation, manufacturing, labelling and advertising requirements. Or antibacterial skin care products, which are consumer products, but can only make general claims and must not include substances in Schedules 2, 3, 4 or 8 of the Poison Standard.

Slide 65

So to summarise, disinfectants that are therapeutic goods are regulated as listed disinfectants and are generally Class 1 and Class 2B medical devices. They must meet the regulatory requirements for medical devices and their classification. Specific and non-specific claims can be found in the Disinfectant Claim Guide, and applications are submitted in TGA Business Services as shown on the slide. You can find guidance for these applications in the Australian Regulatory Guidelines for Medical Devices. You can also email the devices team at Email us . We are expediting all COVID-19 related applications.

Slide 66

Personal protective equipment, or PPE, such as face masks, face shields, goggles, gowns and gloves are designed to protect the wearer from injury, spread of infection or illness. The presentation including claims for the product will determine whether it's regulated as a therapeutic good or a consumer product. PPE which are non-sterile and designed as safety or protective apparel are excluded from regulation under the Therapeutic Goods Declared Goods Order 2019, as long as they do not claim to be for surgical, medical or therapeutic purposes.

Slide 67

PPE are regulated as therapeutic goods when they are for therapeutic use, such as being labelled for clinical or surgical use, and/or claim to reduce or prevent the transmission of disease or micro-organisms such as bacteria or viruses. Products which are supplied as non-sterile are likely to be regulated as Class 1 medical devices. When supplied as sterile, they will be considered Class 1 sterile medical devices, and will require manufacturer's evidence to ensure the sterility aspects have been met. And if for use in a setting that is surgically invasive to the body, for example surgical gloves, these are likely to be regulated as Class 2A medical devices.

Slide 68

To recap, when regulated as therapeutic goods, PPE are generally regulated as a Class 1, Class 1S sterile or Class 2A medical device. They must meet the regulatory requirements for medical devices and their specific classification. Reprocessing of single use PPE should only be considered to address critical supply shortages and where there is no alternative available. For further information, refer to the COVID-19 page of the TGA website on re-use of face masks and gowns. As mentioned, we are expediting all COVID-19 related applications, and you can find guidance in the ARGMD or contact the devices team.

Slide 69

Let's take a look at another case study. This is Gerry, and he wants to supply a disinfectant. Let's take a look at what steps he needs to take.

Slide 70

Some disinfectants are excluded from TGA regulation by the Therapeutic Goods Excluded Goods Determination 2018. While they may be required to meet relevant legislative requirements under consumer legislation, they are not required to meet any of the legislative requirements by TGA.

The following products are excluded from regulation under different legislative mechanisms. These include disinfectant and sterilant gases, products represented to be for antifungal use only, a disinfectant or sanitiser registered under the Agricultural and Veterinary Chemicals Code Act 1994 for which no claim or representation for disinfectant use is made, other than a use which is registered for the disinfectant, disinfectants or sanitisers that are represented to be suitable for the treatment of drinking water only, and contact lens care products.

So after looking at the Excluded Goods Determination, Gerry confirms that his product is not excluded.

Slide 71

Exempt disinfectants are not required to be included in the ARTG before they are supplied, but they must still meet all other regulatory requirements for therapeutic goods. These are hospital grade or household commercial grade disinfectant liquids, sprays, wipes, sponges and aerosols that do not make specific claims, and that are not intended for use internally or on the skin or on a medical device, but are intended for use on inanimate objects such as hard and soft surfaces. Virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity are specific claims. More information on exempt disinfectants can be found in the guidance on the regulation of exempt disinfectants in Australia. So Gerry refers to the guidance on disinfectants, sterilants and sanitary products on the TGA website, and determines that as his product is making specific claims, his product is not exempt.

Slide 72

How disinfectants are regulated depends on whether the product is making specific claims. Hard surface disinfectants are listed disinfectants, regulated as other therapeutic goods. And they are further defined as hospital grade or household commercial grade disinfectant liquids, sprays, wipes and aerosols that make specific claims, and that are not intended for use internally or on the skin or on a medical device, but are intended for use on inanimate objects such as hard and soft surfaces. These are regulated as listed disinfectants, which are other therapeutic goods.

Making claims that a product kills or is active against viruses, spores, tuberculosis, mycobacteria or fungi are considered specific claims. Gerry refers to the disinfectant claim guide to determine what are specific and non-specific claims, and confirms that as his product claims to kill viruses, his product is regulated as a therapeutic good.

He will now need to familiarise himself with the regulatory requirements for supplying a disinfectant as a therapeutic good, which he finds in the guidance on the regulation of listed disinfectants in Australia.

Slide 73

Gerry knows that his disinfectant is a therapeutic good because it is making specific claims, kills viruses, and therefore he needs to include his product in the ARTG. To do this, he needs to submit an application to TGA. After familiarising himself with all regulatory requirements, Gerry obtains access to TGA Business Services, he logs in to TBS using his client ID, he submits an application as shown on the slide, he pays the associated fee, provides information or data when requested, and receives the outcome of his application. If approved, Gerry can supply his disinfectant, but he must also comply with all relevant regulatory requirements.

Slide 74

Our next stop now is manufacturing, and I'll take you through some key elements of this process.

Slide 75

Manufacturing is any stage of the production of the good and depends on the type of product, but can include the following steps. Producing, processing, refurbishing, assembling, packaging, labelling, testing and release for supply.

Slide 76

There are certain regulatory requirements that must be met when it comes to manufacturing, and we assess the manufacturing process to make sure that they meet certain standards. The standard for assessing medicines and biologicals is called Good Manufacturing Practice, or GMP. The assessment process for medical devices is called Conformity Assessment. Both of these have guidelines and criteria that need to be met to demonstrate compliance. For medicines and biologicals that contain live animal cells, tissues or organs, the criteria is the PIC/S Guide to GMP. PIC stands for Pharmaceutical Inspection Scheme, or Pharmaceutical Inspection Convention and Pharmaceutical Inspection and Cooperation Scheme. For biologicals that are derived from human cells, tissues or blood products, it's the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products. For medical devices, the set of criteria for assessing manufacturing is called the Essential Principles. Manufacturers are required to have a Quality Management System, or QMS, in place, and demonstrate compliance with the Essential Principles for safety and performance. Conformity Assessment uses a risk based approach so that higher risk devices are assessed in more detail.

Slide 77

Manufacturers that meet the standards are issued with a certification. This is the manufacturing evidence that you will need to present in your application. For medicines and biologicals, if your manufacturer is located in Australia, they need to obtain a GMP licence from TGA. They have to submit a GMP application to us with details about their manufacturing site. This may also involve an on site inspection. After the inspection, the manufacturer then forwards the details of the GMP licence on to the sponsor. The sponsor is considered responsible for ensuring their manufacturer has a GMP licence.

If your manufacturer is located overseas, then it's the sponsor's responsibility to make sure their manufacturer has GMP clearance as opposed to a GMP licence. The sponsor then submits this manufacturer's evidence as part of their market authorisation application.

For medical devices, if a manufacturer can demonstrate that they meet the Essential Principles for safety and performance that are relevant to the device, they are issued a certificate or they make a declaration of conformity. Note that the manufacturer evidence does not need to be submitted as part of the application for a Class 1 or export only device, but it must be available upon request after inclusion in the Australian Register of Therapeutic Goods. For other device types, the sponsor has to submit the manufacturer's evidence through TGA business services, and get approved before submitting an application for market authorisation.

The sequence of events is slightly different for medicines and biologicals compared to devices. For medicines and biologicals, the manufacturer evidence is submitted with the market authorisation application. For devices, you submit your manufacturer's evidence first, pay the fee, get approval, and then submit your market authorisation application. We have the Good Manufacturing Practice Application Decision Tree that can help you determine what type of GMP application may be required.

Slide 78

If your manufacturer is located overseas, you have a few options to obtain GMP clearance or a declaration of conformity. We have various international agreements and arrangements with other countries and jurisdictions, called Mutual Recognition Agreements, or MRAs. For medicines and biologicals, there are around 25 different countries that have an MRA or equivalent agreement with Australia. These include the United States, Canada, Singapore, United Kingdom, and numerous European countries. If your manufacturing site is none of these or you're not eligible for MRA, you have to obtain GMP certification through TGA, which may involve an on site inspection by one of our GMP inspectors.

For devices, we have Mutual Recognition Agreement with Europe and the UK. MRA certification is issued under Australian law and treated much like TGA certification. We also have comparable overseas regulators or conformity assessment bodies, which include all of the countries and regulatory authorities mentioned earlier. Applications for inclusion using these may be subject to an audit, and audit is mandatory for some higher risk devices. In essence, we accept manufacturing certification issued by us, and we also accept certification or other evidence of regulatory approval from some other countries.

Slide 79

We regularly inspect manufacturers of therapeutic goods to ensure compliance. Inspections can happen at any stage during the market authorisation process, from pre-market through to post market. Generally we'll contact the manufacturer informing them that an inspection will be carried out and agree on an inspection date. Inspections may take a day or two. The inspector identifies any deficiencies, then the manufacturer has to address these deficiencies and provide a response detailing any corrective or preventative actions. The manufacturer must agree to have their site inspected if required. It's the sponsor's responsibility to have an inspection agreement in place with the manufacturer.

Slide 80

For our case study, we have Susie, and she wants to be the sponsor of a prescription medicine that is manufactured in Portugal. Because the manufacturer is based overseas, Susie is responsible for obtaining the GMP clearance.

Slide 81

Susie's first step is to confirm the following details with her manufacturer. If the product is regulated as a medicine in Portugal. Susie confirms it is. Whether the site has recently been inspected by the Portuguese regulator. Susie confirms that it has. And if the manufacturer has a GMP equivalent certificate to TGA standards. Yes, they do, and they forward this on to Susie.

Slide 82

Susie uses the GMP Clearance Application Assistance Tool to check the general evidence requirements for her GMP application. The tool guides her to find out more details about her product. She needs to check the Mutual Recognition Agreement list of countries. If a country is not listed, then you can't use that pathway. Mutual recognition is the most straightforward pathway, but you may be able to use other pathways.

Slide 83

The tool asks Susie to check if her type of product can be issued with GMP clearance. GMP clearance can be issued for manufacturers of non-sterile active pharmaceutical ingredients, or APIs, non-sterile finished products, sterile or biotech APIs, sterile or biotech finished products, and contract testing laboratories. She sees that she can get GMP clearance for non-sterile products, such as her tablets.

Slide 84

There are three possible options for GMP clearance. The first is Mutual Recognition Agreement pathway, which you could use if your manufacturing site is within the borders of an MRA country and your site has been inspected by that country's regulatory authority. The second is the compliance verification pathway, which you could use if the manufacturer doesn't meet the criteria for MRA and the site has been inspected by an MRA regulatory authority.

The third is the GMP certification pathway, which you could use if the MRA or CV pathways are not applicable, or no acceptable evidence from a recognised regulatory authority is currently available, for example if you require a GMP certificate for your sunscreen, which may not be classed as a medicine in another country. In Susie's case, she can proceed down the MRA pathway, because she confirms that Portugal is an MRA country, her product is regulated as a medicine in Portugal, the site has been inspected by Portugal's regulatory authority and to TGA standards.

Note that if Susie's site hadn't been inspected by Portugal's regulatory authority, she would not have been able to pick option three involving a TGA inspection. This is because we have a Mutual Recognition Agreement with Portugal, and we would ask their regulatory authority to perform an inspection on our behalf. We would only perform an inspection if the product was not regulated as a therapeutic good in Portugal.

Slide 85

To proceed down the MRA pathway, the overseas regulator must meet TGA standards for GMP codes and have recently inspected the manufacturing site to TGA standards. Evidence must be current, accurate, complete, and translated to English if necessary. Note that this refers to the MRA annex on GMP, the Sectoral Annex on Medicinal Products, GMP Inspection and Batch Certification. There is also a separate MRA Sectoral Annex on medical devices.

Slide 86

So Susie submits her GMP clearance application through TGA Business Services by logging in and selecting 'Clearance Application,' providing the required details, paying the fees, and agreeing to the declaration. Susie has now submitted her GMP clearance application. I'll now hand you back over to Jayne. Thank you.

Slide 87

Jayne Foster: Thanks Mel. Okay. So now that the goods are on the market, let's take a look at advertising and what that entails.

Slide 88

So advertising requirements apply to all therapeutic goods. It doesn't matter if it's a medical device or a complementary medicine. Some medicines, such as prescription medicines and biologicals, have requirements that mean they can't be advertised to consumers.

So what is advertising?

Advertising is considered any promotional material. It includes, but isn't limited to, the medicine labels, TV advertisements, websites, and this includes social media sites, and it's regulated by the Therapeutic Goods Act, the Therapeutic Goods Regulations, and the Advertising Code.

Slide 89

So advertising is your responsibility. The Advertising Code applies to all therapeutic goods to varying degrees, and the Advertising Code outlines the key requirements that must be met when advertising therapeutic goods. So you need to familiarise yourself with this piece of legislation, and understand what you can and cannot do.

Make sure you're aware of what all of your labels and any advertisement says. Are you being misleading, and do you hold evidence that your product works in the way that you're suggesting it does?

And don't wait until a complaint comes through to TGA or we audit you to be compliant. You can make changes at any time to correct your mistakes and ensure compliance. And we have lots of guidance available to help you, and we also have TGA contacts who you can contact at any time.

Slide 90

So many of the rules of advertising are contained in the Advertising Code, and this Code regulates what can and can't be said when it comes to advertising. And it's broken down into sections, with some of the key sections highlighted on this slide. As mentioned, we have specific Code guidance available to help you interpret the Code, and we suggest you read this in conjunction with reading the Code. And you can find all of this guidance on the Advertising Hub.

Slide 91

So the Advertising Hub lives on the TGA website, and this is a one stop shop for all things advertising. It contains guidance and educational material, as well as information around complaints. It also contains an email address so that you can contact the advertising team at any time if you're unsure of your requirements or you're having difficulty interpreting the Advertising Code.

Slide 92

So why do we regulate advertising? Well we regulate advertising because not only can a false claim be misleading, but it can also be unsafe. Advertising must not be socially irresponsible or mislead or deceive the consumer.

Slide 93

And you can see here in these small examples how bad advertising can be dangerous to a consumer.

Slide 94

So let's look at a little case study. This is Dan. He has a listed complementary medicine calls Bean's Tonic. And we'll have a look at what he should and shouldn't do when advertising on his product's label.

Slide 95

So although this is a medicine label, the breaches shown would apply to any advertising material, so be it a TV ad, a magazine article, a social media post, etcetera, for any therapeutic good that's allowed to be advertised to the public.

So here are the breaches, and we'll go through them.

So the Advertising Code gives information about endorsements. Your advertisement cannot be endorsed, either directly or implied by certain factions, such as government organisations or health professionals. In this example, Dr Seuss is representing a health professional. He's saying he loves beans. We might question is this really supporting or endorsing the product, but because the name of the product is about beans, Bean's Tonic, this is taken to be an indirect endorsement of the goods and we would consider this a breach.

And graphics and images are not immune to advertising either. The government logo on this label is enough to be a breach, as it implies government endorsement. Just because your goods are being supplied on the market and they might have been reviewed post-market or they might have gone through a pre-market assessment by TGA, TGA does not endorse your product, and this would be considered a breach.

You can also not reference serious forms of diseases, ailments or conditions, unless you have prior approval from TGA. And we call these restricted representations. So in our example they don't have prior approval, so using this restricted representation would be considered a breach. A restricted representation is defined in the legislation, but in general, it's a serious form of disease, ailment or condition that ought to be diagnosed and managed by a health professional. So this indication regarding diabetes is a breach, as diabetes is a restricted representation.

And the last breach relates to the diabetes indication again. You cannot advertise an indication that's not present on your ARTG entry. This indication wouldn't be allowed on the ARTG entry, because it's a restricted representation. That is unless they had prior approval. But this would be another breach.

Slide 96

So while there are advertising restrictions that apply to therapeutic goods, such as the use of restricted representations and Schedule 3 substances without approval from TGA, there might be circumstances in which the advertising of these products might be permitted. So in the interests of public health, this year in January TGA granted temporary permission to pharmacies to advertise puffers and inhalers containing salbutamol due to smoke and air pollution from the Australian bushfires. So we also published a blog more broadly on managing medicines in an emergency. So salbutamol is an important medicine for the relief of respiratory symptoms associated with asthma, chronic obstructive pulmonary disease and other respiratory diseases, which are considered restricted representations. Furthermore, salbutamol is considered a Schedule 3 substance in the Poison Standard, which means it cannot normally be advertised to the public.

Slide 97

So here is a second case study looking at advertising and social media. This is Daphne. She's the sponsor for a device called a TENS machine, or TENS best, and she has a Facebook page to help promote her product.

Slide 98

So here is a snapshot of Daphne's Facebook account and her most recent post. Remember that social media platforms do count as advertising.

So the claims in the advertisement are quite low level. They don't seem to be exaggerated, and they're responsible in terms of not encouraging people to delay medical treatment or ceasing a prescribed pain management strategy. The photos are of a generally healthy individual, and all applicable warnings are present. So where is the breach? Well let's take a closer look at some of the comments made by strangers.

Slide 99

So comments in a social media post are considered testimonials, and you as the sponsor are responsible for ensuring that all testimonials comply with requirements. So an example is that comments must illustrate typical cases, and they have to comply with all other advertising requirements. So they can't be misleading for example. So Mr Bikeman here is making a simple statement that doesn't reflect on the product's capabilities, so that's fine.

Ana's also fine. She's making some reasonable statements about how she feels about the product and how it helps her.

Then we get to Simon. He's started to see his bones getting thicker and stronger, and he's saying that the product's going to be great and it will prevent rheumatoid arthritis. So this kind of statement isn't what we would consider typical from the results expected from the use of this therapeutic good, and it's also not a typical case.

A typical case would be more along the lines of what Ana says about providing general pain relief. And this comment also mentions a restricted representation, rheumatoid arthritis. The product has made no reference to or claim to help with arthritis in any form.

So Daphne herself has not made any errors, but Simon has, and it's the sponsor's responsibility to ensure that all testimonials adhere to the Code. So what can you do? You need to moderate your posts and delete any comments that are non-compliant. Keep the positive and accurate testimonials, once you're satisfied that they comply with the Code, and remove any that are likely to land you in trouble. So testimonials must be from verified users, they must illustrate typical cases, and they need to comply with all other requirements.

Slide 100

We'll now move on to post-market monitoring. So what does that mean?

Slide 101

So post-market monitoring is the continued upkeep of your therapeutic good once it's on the market. As a sponsor, you are responsible for ensuring that your goods remain compliant, and report back to TGA any problems. There are a few things to consider as part of post-market monitoring that you will need to mandatorily report back to TGA once your goods are on the market.

So you must collect and record all adverse events. The term adverse events here is broad, and encompasses many different types of adverse events, such as reactions, which I'll explain in more detail shortly.

For medicines we also have deficiencies or defects, and we also have medicines shortages. These have mandatory reporting requirements, which I'll explain in more detail as well.

For devices, in addition to adverse incidents, reporting is also required for overseas regulatory actions, and the results of investigations undertaken by the manufacturer, such as further clinical studies and reviews of adverse events. We'll now go through the basics of an adverse event for both medicines and medical devices.

Slide 102

So reporting an adverse event to TGA helps us to understand current issues and prevent further issues with therapeutic goods. So medicines and medical devices have different pathways when reporting an adverse event, but the concepts behind them are very similar.

So for medicines, the term used for capturing adverse events is pharmacovigilance, and the serious adverse reaction reports are received by the pharmacovigilance team. For medical devices, it's included as part of post-market vigilance. Adverse event reports go to the devices post-market monitoring team.

For medicine sponsors, it's mandatory for you to notify TGA of your Australian pharmacovigilance contact person within 15 calendar days of your first ARTG entry. So we want you to establish and maintain a pharmacovigilance system that helps you collect, record and assess serious adverse event reports, and we need to know who to contact in the case of an unexpected event.

You may also be subject to pharmacovigilance inspections, where we will examine your compliance with the applicable Australian pharmacovigilance legislation. Investigations are typically focused on unusual or potentially serious problems, or problems that have high levels of incidences.

Both pharmacovigilance and medical devices can request information from you to audit and to ensure compliance. And note that TGA's request for information is actually a legal request under the Act, and has strict timeframes that you need to adhere to. And the biovigilance team is who you'd report to if you have a biological. We perform audits of medical devices to make sure you're compliant with the Essential Principles. Reviews might be done following an adverse event or when we conduct a post market review on a kind of device.

Medical devices do not require you to delegate a particular person for adverse events, but keep your contact details in TBS up to date. Consider using a general email so that the email is not missed if somebody is away for example. The devices post-market monitoring team may go out on inspections in the future, but at this stage the team are not conducting inspections.

Slide 103

So there are two main concepts shared when it comes to reporting. You need to collect all reports of incidences, big and small, from the reporting person, and you need to keep all of your records. For medicines, you need to always record four main points of information from the reporter for every report. For medical devices, the adverse event reporting form prompts you to collect more information from the affected user and the manufacturer. But best practice here is to collect as much information as you possibly can.

Slide 104

The terminology of an adverse event is important, because it defines what the event is, if it's mandatory to report, and how long you have to report it to TGA. If you're unsure of the severity of an adverse event, report it. Treat it as serious and report it right away.

The pharmacovigilance area have four main terminologies, and bear with me as I read out these definitions. So an adverse event. So this is any untoward medical occurrence in a patient, consumer or clinical investigation which may not have a causal association with the medicine. For an example, an abnormal laboratory finding.

An adverse drug reaction. So this is a noxious or unintended response to a medicine, with a reasonable possibility that the medicine caused the adverse event. And thirdly, a serious adverse drug reaction. So this is any adverse drug reaction that results in death, is life threatening, requires or prolongs hospitalisation, results in significant disability or incapacity, or is a congenital abnormality. And we also have significant safety issue. So this is a new safety issue or validated signal considered by you that requires urgent attention of the TGA. An example of this could be finding out that a raw material used in your medicine was not actually as safe as first thought.

You must still collect all reports for any type, but these last two are mandatory for you to report to the TGA. So we'll now look at device terminology, and these have three main categories. So we also have an adverse event. This is an event that led to death, a serious injury, or serious deterioration to a patient, user or other person. So this is different from the medicines terminology for an adverse event.

A near adverse event is an event that might have led to death or serious injury. And we also have a serious public health threat or concern. So this is a hazardous event arising from systematic failure of a device, usually coming from an adverse event or near adverse event itself. Typically it would be something that the TGA must act on swiftly to avoid public as opposed to individual safety. And all of these are mandatory for you to report to TGA.

So timeframes vary depending on the type of adverse event. Timeframes are strict and they're in calendar days. So this means that public holidays and weekends are not exempt. It's important that you read the relevant guidance material to understand the required timeframes. So you can click on these 'i' links on this slide to take you to the relevant information.

As an example, for a significant safety issue you have 72 hours to report this to TGA. And for a serious public health threat or concern for a medical device, you have two calendar days.

Slide 105

So how do you report to TGA? Well again, this differs for medicines and medical devices. For medicines there are three main ways to report a serious adverse reaction. Through TGA Business Services, there's an online form available through the TGA website, and you can also email at the address shown on this slide. Significant safety issues are reported through email. And medical devices have an online form that's available through your TBS account for all reports.

Slide 106

Finally, there are two other mandatory reporting responsibilities to remember, and these apply to medicines. So a medicine deficiency or defect needs to be reported to TGA. We expect you to monitor the manufacture, storage and handling of your medicine, and report any deficiencies or defects you find, even if it's just in a single batch.

The medicine shortages mandatory reporting scheme only applies to prescription and some OTC medicines. So for these medicines, it's a mandatory reporting scheme helping TGA monitor shortages of critical medicines, making sure that Australia doesn't run out of life saving medications. But you can report a shortage for any medicine. It's available to you and it's voluntary, even if you don't have a prescription or a specific OTC medicine.

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So that brings us to the final case study. This is Daphne and her TENS machine again. So we'll have a look at how she reports an adverse event.

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So what do you do if someone reports they've been injured by your medical device? So Daphne receives an email from an affected user who claims they've hurt themselves using her TENS machine product. Daphne's somewhat sceptical that anyone could harm themselves using her device. The user claimed they strained their wrist using it. But ignoring the email is not best practice. She needs to report the incident to the TGA as an adverse event. So she visits the TGA website, finds out more information on reporting and advice on adverse event reporting for medical devices.

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So Daphne's first step is to consider what type of adverse event she has. Medical devices have both adverse events, as you recall, and near adverse events. And these can be associated with the use or misuse of a device. So an event involving a medical device does not have to involve a patient or a user. This doesn't exclude it from being reported. So an adverse event is an incident remember that resulted in serious injury, illness or death to the patient, health care professional or other person.

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A near adverse event is similar, except that it could have resulted in serious injury. So Daphne's a little confused. The complaint doesn't seem very serious. How could someone strain their wrist using a TENS machine? Daphne talks to her friend Susie. Susie reassures Daphne and tells her that if she's unsure, she should just report it. The active reporting is not an admission of the manufacturer, sponsor or user of patient liability for the event or its consequences. An adverse event does not necessarily mean that there's something wrong with the product. And Daphne doesn't know the extent of the wrist strain. What if it turned out to be quite serious? Maybe it could be a skin burn. Susie reminds Daphne that there are expected reporting timeframes for adverse events, and she'll need to follow these.

So together they look at the TGA website. They follow the guidelines, and determine they have 30 calendar days to report the incident. And she'll also have to inform the manufacturer.

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The website prompts Daphne to collect information from the affected user. At the bare minimum, she'll need to include the details about herself as the reporter, about the affected user, referred to as the patient, the product itself, and the incident. So Daphne gets back into contact with the affected user, now known as the patient, and gathers all of this information from him.

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Daphne now needs to report this information back to TGA.

She learns that the online form for reporting is actually done through her TBS account.

She refers to TGA guidance material on how to submit a report through the MDIR system. Using the step by step guide, Daphne hits 'Submit' and successfully creates a new report of the incident. This report is called the initial report. But she doesn't have all of the information required yet to make it a final report.

Daphne receives a DIR number, a Device Incident Report number. This is created. She needs to keep this number. She'll need it later.

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So this is not the end of Daphne's adverse event reporting. Within the initial report, as she's filling it out, she's prompted to seek more information.

So Daphne needs to now check her own information and report this to TGA. She needs to assess her own Quality Management System, or QMS, and her own surveillance practices when supplying her TENS machine. She also needs to check that she hasn't received a similar complaint about the product, and also from overseas if she supplies the product overseas.

Then Daphne needs to log back into her TBS account and update her initial report using the DIR number that was provided. After providing the additional information, and again hitting 'Submit', her initial report turns into a final report.

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So once TGA receives the final report, we'll typically contact a sponsor within three to four business days, and this is all done via email. The email typically contains further questions about the report for the sponsor to answer. We might want to know the current supply numbers of the device or request a copy of instructions for use, and ask for the sponsor's analysis. So Daphne answers all of these questions.

As it turns out, TGA has received numerous reports of wrist strain from the improper use of TENS machines. So although no one had previously struggled with Daphne's device, the TGA held a much bigger picture and view. That's why it's really important to report. TGA informs Daphne that because of a growing number of misuse cases, we require her to update her information for use sheet. She needs to include the warning 'Do not use on wrists' or words to that effect.

So that brings us to the end of the case studies for today. I hope that makes your navigation of therapeutic goods regulation somewhat clearer. But we'll now be taking a short break. I think we finished a little bit shorter than anticipated. The Q&A session will start at 3:30. The link should be available from 20 past 3:00, and you'll have the opportunity to submit questions.

You should also have received an email today requesting that you complete an evaluation form, so I'd really appreciate your feedback and help with improving further workshops. Thank you.