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Supplying certain therapeutic goods for COVID-19

11 August 2021

Duration: 
17 minutes 04

In this episode, we talk with Brian Chamberlain from the Medical Devices Authorisation Branch at TGA and explore:

  • some of the products being supplied for COVID-19
  • how these are regulated
  • where to start if considering supplying these products in Australia
  • how the features of a product can impact how it’s regulated
  • tools and information helpful for those new to supplying therapeutic goods
  • the application process.

Host: Steven Smith-Fleury

Guest: Brian Chamberlain


Introduction

Welcome to the Therapeutic Goods Administration’s podcast series, SME Assist - Navigating therapeutic goods regulation. We appreciate that the regulation of therapeutic goods can be challenging to understand. Throughout this series, we aim to help small to medium enterprises, researchers, start-ups and anyone new or unfamiliar with the regulation to understand their obligations when it comes to supplying therapeutic goods in Australia.

Please note that the information provided to you throughout these podcasts is without prejudice. It is not binding on the TGA and you should get your own independent legal advice to ensure that all of the legislative requirements are met.

Steven Smith-Fleury

Hi, I’m Steve from the SME Assist team at the Therapeutic Goods Administration or TGA. Thanks for joining us for episode two in our podcast series. And if you haven’t already, please be sure to hit subscribe and listen to our previous episode where we learned about the role of the TGA, the Australian Register of Therapeutic Goods or ARTG, TGA’s dedicated SME Assist service and some of the things that have been happening here during the COVID-19 pandemic.

If you haven’t had a chance to listen to episode one, the Australian Register of Therapeutic Goods, or ARTG is a database that lists all of the therapeutic goods that can be lawfully supplied in and exported from Australia.

Today we’ll be speaking with Brian Chamberlain who works within the medical devices authorisation branch at the TGA about supplying certain therapeutic goods for COVID-19. Welcome, Brian, and thanks for being with us today.

Brian Chamberlain

Hi, Steve. Thanks for having me.

Steven Smith-Fleury

Brian, could you please start by telling our listeners about what the medical devices branch does?

Brian Chamberlain

Yeah, definitely. So the medical devices branch is responsible for the regulation of medical devices in Australia, which means ensuring that they’re safe, of good quality and perform as intended. We assess applications and evidence before a product can be supplied in or exported from Australia, but our responsibilities don’t stop there. We then look after important activities to ensure the safety and performance of the device continues after it’s made available to the public.

Steven Smith-Fleury

So, what is a medical device, Brian?

Brian Chamberlain

Yeah, so, in general, medical devices are intended to be used for humans. They’re intended to diagnose, prevent, monitor, treat or alleviate a disease or injury, or modify or monitor the anatomy or physiological functions of the body. They generally achieve their purpose by a physical, mechanical or chemical action in or on the body.

Almost anything can be a medical device if it’s presented in line with the legal definition. They generally have a physical or mechanical effect on the body, or measure or monitor bodily functions. They can include anything from tongue depressors and condoms to implantable defibrillators and pacemakers.

Steven Smith-Fleury

So, it’s definitely a wide-ranging space, isn’t it?

Brian Chamberlain

It certainly is. Even that coffee cup you’re holding could be considered a medical device. If it were presented to contain a bodily fluid, for example, it could be perceived as a specimen container.

Steven Smith-Fleury

Wow, that’s really interesting. Now, Brian, we know that COVID-19 has affected the healthcare sector and its resources immensely. How has the pandemic affected the work carried out within your branch at the TGA?

Brian Chamberlain

Yeah, it’s been particularly challenging, Steve. We’ve seen very high volumes of applications coming in for products to combat the pandemic, such as disinfectants, hand sanitisers, personal protective equipment like face masks, we’ve seen COVID-19 test kits and temperature measuring devices.

Steven Smith-Fleury

Does that mean that it’s taking longer than usual to assess medical device applications?

Brian Chamberlain

Understandably there’s been some delays, but we continue to meet our targeted timeframes, while we prioritise COVID-related applications and associated activities. We want to be sure that the public and healthcare providers have access to quality products to respond to the COVID pandemic when they need them. And, of course, we have our normal business-as-usual applications for non COVID products that are still coming through, so we need to address these as well.

Steven Smith-Fleury

That’s really reassuring to hear, Brian. 

Now, some of our audience might be thinking about doing their bit to supply products for COVID-19. I might just take my TGA hat off for a moment and ask you as one of them, what are some of the things that I need to be aware of and where should I start?

Brian Chamberlain

So, first, you’ll need to work out if your product is indeed a therapeutic good. We have a couple of great interactive decision tools on the SME Assist section of our website. One’s called, ‘Is My Product a Therapeutic Good?’ And another useful tool is, ‘Is My Product a Medical Device?’ These really do help in making this decision.

Steven Smith-Fleury

Great. So, my product is a therapeutic good and I know what type it is. What’s next?

Brian Chamberlain

From here you can refer to the relevant Australian regulatory guidelines on our website, which explains your ongoing obligations as a sponsor and how to make an application. You might also like to familiarise yourself with any applicable fees and charges at this point in time.

Steven Smith-Fleury

Just a quick note for our listeners here, that we also discussed the role of a sponsor in Episode 1 of this series, so be sure to check it out. Now, TGA hat is off again. Brian, if my product is being made overseas, can I import it before or while I’m making an application?

Brian Chamberlain

No, Steve. Prior to importing, exporting or supplying the product, it’ll need to be included into the ARTG, unless of course it’s exempt or excluded from this requirement.

Steven Smith-Fleury

That’s really handy information, thanks, Brian. 

Now, I’m ready to get my product onto the ARTG, how do I actually make an application?

Brian Chamberlain

So, Steve, you’ll need to get access to our eBusiness Services portal. To do that, you’ll submit an organisation details form to the TGA. You can then refer to the relevant guidelines for instructions on how to complete an accurate application, or contact our dedicated info lines where we can provide further general guidance as well.

Steven Smith-Fleury

And, can I start supplying my product as soon as I’ve made an application?

Brian Chamberlain

No, Steve, you’ll need to pay your relevant fee and if your application is approved, your product will be entered into the ARTG. That’s when you can start to legally import and supply this product.

Steven Smith-Fleury

That’s terrific, thanks, Brian. I might just put my TGA hat back on for the rest of today’s episode. Now, you told us earlier that we’ve seen an increase in applications for disinfectants. Can you tell us a bit more about how disinfectants are regulated?

Brian Chamberlain

Disinfectants are regulated differently, depending on the intended purpose of the product and how it’s advertised. Disinfectants will need to go onto the ARTG if they make specific claims, like killing microorganisms on non-living objects that aren’t medical devices, or if they claim to disinfect a medical device.

Some disinfectants don’t need to be on the ARTG, but they still need to meet certain standards. These disinfectants can only make general claims like kills 99% of bacteria and can only be used on non-living surfaces that aren’t medical devices. A disinfectant intended to be used on a medical device must also be included in the ARTG as a Class IIb medical device.

Our website contains specific guidance to the supply of disinfectants in Australia, which has been compiled on the disinfectants, sterilants and sanitary products landing page and can also be found through the COVID-19 landing page. Here you’ll also find more information about specific and non-specific claims.

Steven Smith-Fleury

So, would I be right in saying that a disinfectant that claims to be effective against COVID-19 would require listing on the ARTG?

Brian Chamberlain

Absolutely, Steve. Being a virus, any claims around being effective against COVID-19 would be considered specific and these products will need to be entered onto the ARTG.

Steven Smith-Fleury

And what would a manufacturer need to do to make these sorts of claims legally?

Brian Chamberlain

Well, first, they’ll need to make sure that they comply with our instructions for disinfectant testing, which we call TGO 104. This therapeutic goods order can be found on our website, but alone is not enough to make these claims against COVID-19.

You’ll also need to satisfy the advertising code requirements. To do this, you must have evidence that your product is effective against novel coronavirus. More information about this can be found on the COVID-19 landing page on our website or by contacting us directly.

Steven Smith-Fleury

That’s really helpful. Thanks, Brian. We’ll be covering more information around advertising in a future episode too. Now, if we can move onto something else you touched on earlier, PPE. What is it and when do we regulate it?

Brian Chamberlain

PPE stands for personal protective equipment and includes things like gloves, gowns and face masks. The intended purpose of these products will determine whether we’ll regulate them. Face masks or other PPE are regulated by the TGA when they are promoted for use in a healthcare setting or to prevent the transmission of disease.

PPE can be classified differently, but as an example, most are Class I medical devices, unless they’re supplied sterile, then they would be regulated as a Class I sterile medical device. It is important that sponsors determine the classification of their products correctly to avoid non-compliance and potential further regulatory actions.

Steven Smith-Fleury

So, it sounds like correct classification is important when it comes to medical devices, Brian. What assistance can we provide to potential sponsors in this respect?

Brian Chamberlain

Yes, Steve. The SME Assist section of our website has a really helpful tool called ‘What Classification Is My Medical Device?’ This can help sponsors in determining their product’s classification.

Steven Smith-Fleury

And can people get guidance anywhere else?

Brian Chamberlain

Yes, Steve. The manufacturer of the device is ultimately responsible for correctly classifying their product, but if in doubt, sponsors and manufacturers should refer to the relevant ARGMD or the classification rules provided in the regulations.

Steven Smith-Fleury

That’s great. Thanks, Brian. Now, we’ve looked at disinfectants, we’ve looked at PPE. You mentioned we’ve also seen an increase in the number of applications for temperature measuring devices?

Brian Chamberlain

We certainly have, Steve. These type of products include things like thermometers and thermal imaging cameras used to screen people who might have a higher temperature, for example, screening people when entering or leaving buildings. As we’ve mentioned before, it comes down to what the intended purpose is.

Thermal imaging cameras that aren’t intended by the manufacturer for therapeutic purpose, such as those used to detect intruders or catch shoplifters, aren’t regulated as medical devices and can’t legally be promoted as such.

Steven Smith-Fleury

So, are all therapeutic temperature measuring devices classified the same, Brian? 

Brian Chamberlain

No, Steve. Non-battery powered thermometers are treated differently and are Class I measuring devices. Electronic thermometers and temperature measuring devices used to screen people in public places are likely classified as a Class IIa medical device.

Steven Smith-Fleury

And where can our listeners find more information if they’re looking at supplying these products?

Brian Chamberlain

Yeah, we’ve actually published some really helpful guidance on our website on the COVID-19 landing page under the medical devices heading. Again, people can also contact the TGA by phone or email.

Steven Smith-Fleury

Brian, I imagine there’s been considerable demand for COVID-19 test kits in Australia. If listeners are wanting to supply these types of goods, what should they do?

Brian Chamberlain

Yeah, we’re working with suppliers to ensure that Australia has tests available to support the efforts in managing the COVID-19 emergency. All COVID-19 test kits must be on the ARTG in order to be legally imported and supplied in Australia. As the COVID-19 situation changes, processes around supplying test kits may also change, so we recommend that anyone wanting to supply them, contact us for the most up to date guidance.

One thing to be very mindful of, is that the supply and advertising of COVID-19 test kits to consumers for home use is currently prohibited in Australia and anyone found to be doing this could be subject to civil or criminal penalties.

Steven Smith-Fleury

Thanks for that, Brian. So, the last thing we’d like to look at today is the supply of hand sanitisers in Australia. Can you please give our listeners a general overview on how these products are regulated?

Brian Chamberlain

Absolutely. Hand sanitisers are, are antiseptic products that can be either hand washes for use with water or hand rubs for use without water. Some hand sanitisers are regulated as general consumer products or cosmetics and not therapeutic goods. Here we’re talking about products which claims are limited to general, low-level activity against bacteria, again, such as only kills 99.9% of the bacteria, and they don’t contain certain scheduled ingredients. These products can’t claim to kill viruses, for example.

Steven Smith-Fleury

I’m sure there’s a huge demand for hand sanitisers that can be used in healthcare settings. Have we done anything to make sure these providers aren’t caught short on such important tools?

Brian Chamberlain

Yeah. In response to the COVID-19 pandemic, we identified two formulations recommended by the World Health Organisation or WHO and we’ve excluded them from our regulation. These are known as excluded goods. They must meet the requirements as outlined in the exclusion determination. They aren’t regulated by us, but are still consumer goods under Australian consumer law. For more information, listeners might want to contact the Australian Competition and Consumer Commission or ACCC.

Steven Smith-Fleury

That’s great to know. I’m also aware that distilleries around Australia have actually helped to fill, pardon the pun, a gap in the market using these pathways. Now, Brian, what else should we know about the exclusion determination?

Brian Chamberlain

These products can be used in a healthcare setting and for personal use, as long as the exact formulation, manufacturing, labelling and advertising requirements are met. For example, if you make a product to all of the requirements and then add aloe vera, your recipe no longer matches and you cannot supply that to healthcare providers. You might still be able to supply this as a cosmetic type to the public though. More information on the requirements can be found on our website or by contacting the ACCC.

Steven Smith-Fleury

And, now, what about hand sanitisers that the TGA does look after?

Brian Chamberlain

Well, depending on the ingredients and the claims made about what it does and what’s in it, your product might be a therapeutic good. We regulate sanitisers if they aren’t captured by the exclusion determination and make claims to kill specific organisms, such as E. coli or viruses, or are for use in the healthcare settings. These products are regulated as over-the-counter medicines and anybody looking to supply them should read the Australian regulatory guidelines for OTC medicines. Check the COVID-19 landing page or contact us for guidance.

Steven Smith-Fleury

Thanks for that information, Brian, and for being with us today. Unfortunately, we’ve come to the end of today’s episode, so it’s time to say goodbye. I’m sure our listeners have found your insight really helpful and informative.

Brian Chamberlain

No problem, Steve, you’re more than welcome.

Steven Smith-Fleury

So, that brings us to the end of today’s episode where we’ve discussed how to supply certain goods for COVID-19. If you’d like more information, please visit the COVID-19 landing page on the TGA website. Here you’ll find a range of materials that cover how to supply therapeutic goods relating to COVID-19, as well as other important information around how the TGA is working to protect the health of Australians during the pandemic.

The SME Assist service also offers a dedicated phone and email enquiry service, holds webinars and provides the opportunity to attend face-to-face events, such as the Meeting Your Obligations workshop. We encourage you to subscribe to the SME Assist email list to stay up to date with the latest SME information from the TGA and for details of upcoming workshops. If you have any suggestions or questions, please submit them via email to sme.assist@tga.gov.au

Thank you for joining us today. In our next episode we’ll be discussing the role of the TGA laboratories, so please hit subscribe in the Podbean app or wherever you get your podcasts and be sure to check out our website at www.tga.gov.au for more information on the regulation of therapeutic goods in Australia.