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What is the TGA and what do they do?

11 August 2021

Duration: 
18 minutes 07

We speak with Gillian Mitchell, First Assistant Secretary of the Regulatory Practice and Support Division at TGA and learn about:

  • the role of TGA
  • what a therapeutic good is
  • the Australian Register of Therapeutic Goods
  • how the COVID-19 pandemic has impacted operations at TGA
  • accessing unapproved therapeutic goods like medicinal cannabis

Host: Dr Jayne Foster

Guest: Gillian Mitchell


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 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.

Dr Jayne Foster

Hi, I'm Jayne Foster, Assistant Director within the Regulatory Guidance, Assistance and SME Section at Therapeutic Goods Administration, more commonly known as the TGA.

Welcome to the first in our series of podcasts, ‘What is the TGA and what do they do?’ where you'll find information about the role of the TGA and the kind of support available to those who may be new to therapeutic goods regulation, or have never even heard of us.

In future episodes, we'll be talking to people who work across various regulatory areas at TGA to learn about what they do, and the impact COVID-19 has had, and continues to have, on their day-to-day work. We will chat to staff working within key areas such as medical devices, manufacturing, compliance, advertising and even our laboratories. We will also learn about supplying certain therapeutic goods during COVID-19.

All of these areas have a critical role to play in ensuring products are safe, high quality and do what they're supposed to. All our work here at the TGA benefits the health and wellbeing of every Australian. So, let’s get started.

Joining us today, we have Gillian Mitchell, the First Assistant Secretary of the Regulatory Practice and Support Division within the TGA. I really appreciate you taking some time out of your busy schedule to speak with us today.

Gillian Mitchell

Hi, Jayne. Thanks for having me.

Dr Jayne Foster

Gillian, could you please explain to our listeners what the Therapeutic Goods Administration is and why we exist?

Gillian Mitchell

So, the Therapeutic Goods Administration is actually part of the Commonwealth Department of Health, and we are the regulatory body that oversees the manufacture and supply of therapeutic goods in Australia. This includes importing, exporting and even the advertising of therapeutic goods. We're here to make sure that the goods that are supplied are safe and do what they're intended to do.

Dr Jayne Foster

Gillian, could you please explain to us what exactly is a therapeutic good, and how would I know whether or not my product is a therapeutic good?

Gillian Mitchell

That’s a really great question, Jayne, and it’s a question we get asked lots. So, therapeutic goods are broadly defined as products for use in humans. So, for example, goods that prevent, diagnose, cure or alleviate an illness, a disease, a defect or an injury, things that might influence, inhibit or modify a physiological process, testing the susceptibility of persons to a disease or ailment, influencing, controlling or preventing conception, and testing for pregnancy.

Now, that’s quite a lot of information to take in. So, one of the easiest ways for people to determine whether their good is a therapeutic good or not is to use the tools available on the TGA website. For example, there's a tool on there called, ‘Is My Product a Therapeutic Good?’ and it will walk you through a series of questions about the product to help you identify whether it’s a therapeutic good, and if so, the type of therapeutic good that it’s likely to be.

So, I’d actually encourage any new sponsors who thinks their products could potentially be a therapeutic good, or is making therapeutic claims, to pop on to our website and have a look at the tool.

Dr Jayne Foster

Thanks, Gillian. And what are some typical examples of the types of therapeutic goods that TGA regulates?

Gillian Mitchell

Well, there's a huge range of goods, Jayne that we use every day. So, they include things like complementary medicines, so, vitamins and minerals, over-the-counter medicines, where you go into the pharmacy and buy something, or, actually the supermarket. So, it could be, paracetamol, prescription medicines, where you go to your doctor first and get a prescription and then hop off to the pharmacy.

It also includes things like biologicals and medical devices. And medical devices could range from a tongue depressor right up to a heart valve or a defibrillator, as well as an in-vitro diagnostic or medical device like a pathology test. Even if you intend to provide the product free to someone, you still need to meet the regulatory requirements.

Dr Jayne Foster

That sounds like a huge range of products that are common in daily life. How about some of these recent apps available on phones and watches?

Gillian Mitchell

Of course, it’s a very new and emerging area. But there are some software and mobile apps that do meet the definition of a medical device. And so, we regulate those as well.

Dr Jayne Foster

All right. And what about some of those products that we see taking up more and more room on the supermarket shelf? I've seen lots of probiotics and some teas. Are these also considered to be therapeutic goods?

Gillian Mitchell

Yeah, a good question. Sometimes it’s actually quite unclear whether products are classified as a medicine or a therapeutic good, or whether they're a food. And we call these interface products. So, it’s really important that sponsors know whether their product is a therapeutic good or a food, as each is regulated differently and has different requirements. So, again, I would refer people to the TGA website. There's a really helpful tool on that website called ‘Food-Medicine Interface Guidance Tool’, which will help people identify whether their product is a therapeutic good, and if so, the type of therapeutic good that it’s likely to be.

Dr Jayne Foster

So, in a practical sense, Gillian, how does TGA approach regulation of therapeutic goods to ensure that Australians have access to safe therapeutic goods that work the way they're supposed to?

Gillian Mitchell

Well, as you would expect, Jayne, we operate within a regulatory framework which includes a range of legislation. And the main piece of legislation is the Therapeutic Goods Act. And we also maintain the Australian Register of Therapeutic Goods. The regulatory framework is designed to ensure therapeutic goods are safe, of good quality and do what they're supposed to do.

So, we take a risk-based approach to regulation, and we assess the evidence of the risks compared to the benefits of the therapeutic products. And we do this by applying scientific and clinical expertise from our team of highly-qualified staff including medical officers, scientists, pharmacologists, pharmacists, toxicologists, and so on. We also seek independent expert advice through our range of external advisory committees.

Dr Jayne Foster

Thanks, Gillian. And what about safety? Like, for example, what if someone experiences an allergic reaction to their medication?

Gillian Mitchell

Yeah, look, that’s really important, Jayne. We do monitor safety, and we use information from various sources including the community. So, community members can actually report to us what we call an adverse event, if they have some kind of reaction to their medication. We also get information from healthcare providers, overseas regulators, manufacturers, and, of course, the sponsors of the therapeutic goods themselves.

And if there are some sponsors out there who want to register their product with us, they will need to set up an account with the TGA through our business services portal, and then, they can submit their applications to us to register their products.

Dr Jayne Foster

Thanks, Gillian. So, you mentioned the Australian Register of Therapeutic Goods or the ARTG. Can you tell us a bit more about what that register is exactly?

Gillian Mitchell

Yeah, sure, Jayne. So, the ARTG is an electronic register of therapeutic goods, basically a big database that lists all of the therapeutic goods that can be lawfully supplied, including imported or exported from Australia. So, this allows us to authorise the commercial supply of those goods in Australia.

So, as at 30 June, 2020, listeners might be interested to know that there were 92,060 therapeutic goods on the ARTG, and that list grows year. Every year.

Dr Jayne Foster

So, what kind of information's found on the ARTG?

Gillian Mitchell

So, it contains information such as the product name, the formulation details, the details of the supplier and the manufacturer. And I've used the term sponsor a couple of times, and that’s the word we use to describe the individual or the company who is intending to supply the goods. And it’s the sponsor who's responsible for meeting the regulatory requirements. And that sponsor must actually be someone based in Australia. The ARTG also includes documents such as consumer medicines information leaflet and product information.

Dr Jayne Foster

So, is this information available to the public or only to the sponsors of therapeutic goods?

Gillian Mitchell

Oh no, the information is available to the public, and it’s on the TGA website. You can also search for more information on prescription medicines through an NPS MedicineWise website or their app as well.

Dr Jayne Foster

So, can you give us an example, Gillian, of when a therapeutic good supplied in Australia might not be entered on the ARTG?

Gillian Mitchell

So, normally, therapeutic goods must be entered on the ARTG, but there are times when a therapeutic good might need to be used, but it hasn’t yet been approved, and it might not be on the ARTG.

So, we have a couple of schemes that people can use to access these goods. They're called the, the Special Access Scheme and the Authorised Prescriber Scheme. And these schemes allow people access to medications in Australia where there is a justification that therapeutic goods currently on the ARTG may not be the most appropriate treatment for the individual patient in their particular circumstances.

So, a really good example of this is actually medicinal cannabis. And then, there are things like the Personal Importation Scheme, clinical trials, and access to medicines during a shortage. And there are other situations where medicines not on the ARTG might be supplied for use.

Dr Jayne Foster

And what about exempt and excluded goods?

Gillian Mitchell

So, exempt and excluded goods are other examples where therapeutic goods do not need to be entered into the ARTG. So, for example, tampons and some disinfectants are exempt. What they're exempt from is the requirement to be entered on the ARTG, but they still need to meet certain, certain, regulatory requirements, so, particular standards, information labelling information, that kind of thing.

There's also excluded therapeutic goods that we use every day, like, toothpaste, deodorant, soap, detergent. And most recently due to the COVID-19 pandemic, the TGA excluded specific hand sanitisers from our regulations to ensure continued supply to the health industry and to consumers.

So, again, there's lots of information about these schemes, the Special Access Scheme and the Authorised Prescriber Scheme, for example, and also the exemptions on the TGA website.

Dr Jayne Foster

Thanks, Gillian. So, what about if I'm fairly confident I have a therapeutic good, how do I go about getting my product on the ARTG? Is this a fairly straightforward process?

Gillian Mitchell

Well, Jayne, it really depends on what type of therapeutic good you have, the quality of the data that you’ve got about that good, and the level of risk associated with your product. So, you will need to check your requirements with the relevant Australian Regulatory Guidelines guidance document. So, these are guidelines that are available, again, on the TGA website. And they are specific to each of the different therapeutic good types.

If you're unsure about the requirements, then, you might like to engage the services of an experienced regulatory affairs consultant. And again, there's lots of information about these on our website.

And, as I said before, you will need to set up an account with the TGA through our Business Services portal in order to submit your application and register your product.

Dr Jayne Foster

And what about once the therapeutic goods are on the ARTG? I imagine the work of TGA doesn’t stop there.

Gillian Mitchell

That’s right, it doesn’t. We have, an, a regulatory monitoring role in relation to the ongoing safety of any supplied therapeutic goods. So, we receive and manage adverse event reports from health professionals and the community, and we work with overseas regulators. 

We also monitor and enforce, where necessary, compliance with our legislation around the advertising of therapeutic goods, and also around the importation of therapeutic goods, including those therapeutic goods that are not entered on the, on the ARTG, and may, therefore, be being brought into Australia illegally.

So, COVID-19 has really shone a light on our compliance activities. And you might have seen in the media, all of the infringement notices that we've been issuing lately in relation to the alleged unlawful importation of medical and surgical face masks, for example, as well as unlawful advertising in relation to COVID-19. We do take breaches really seriously, given the possible detrimental consequences for the Australian community.

Dr Jayne Foster

Yeah, thanks, Gillian. They certainly are concerning. We look forward to delving further into the compliance of therapeutic goods in more detail in a later podcast episode, actually, now, we all know the effects that the COVID-19 pandemic has had and continues to have on the health sector. Gillian, how did TGA change and adapt to support the needs of Australians during the COVID-19 pandemic?

Gillian Mitchell

I think the biggest issue for us really was about workload for the TGA and for our staff. There's certain aspects of our work that just couldn’t stop. So, we had to make sure that we maintained our business-as-usual, and then, we also put small tiger teams together to focus on specific work in relation to the pandemic.

We have also seen a large number of, of sponsors who are new to supplying therapeutic goods and may not have knowledge or understanding of regulation and its importance. And we’ve especially seen this in the areas of personal protective equipment, or PPE as we all call it hand sanitisers, disinfectants, over-the-counter therapies and so on.

So, being new to supplying therapeutic goods has meant that some of these sponsors have required extensive guidance, which is something that we’ve done to work with them to make sure that they meet the regulatory requirements. And, of course we've been busy managing medicine shortages and implementing strategies to mitigate the potential for shortages, to make sure that consumers have access to their therapeutic goods.

Dr Jayne Foster

So, what kind of impact has the COVID-19 pandemic had on TGA's relationship with international regulators, Gillian?

Gillian Mitchell

The TGA has always worked closely with international regulators, and it’s been no different during the pandemic, except that it’s just increased.  So, we've had increased dialogue and increased collaboration with regulators and with international regulators, sorry, and assessment bodies. So, we meet regularly with a network of all the major global regulators, and we talk about the pandemic, where clinical trials are up to, the usage of the latest medicines and therapies the approach to vaccines globally, to make sure that we have a joint understanding and that we can also take advantage of potential partnerships in terms of rapid evaluations of new medicines.

So, it's really. I would suggest that it’s a really great idea for people to keep an eye on the TGA website and also on the Department of Health website, and also our social media sites. So, we’re on Facebook, we're on LinkedIn, we’re on Instagram because all the latest news and advice goes up on those sites.

Dr Jayne Foster

Gillian, thanks so much for taking the time to speak with us today, and explaining how the TGA protects the health and safety of Australians. I'm sure it’s really reassuring to our listeners to know that TGA is doing all it can to ensure that Australia has access to safe and effective therapeutic goods. And we wish you all the very best.

Gillian Mitchell

Thanks for having me, Jayne. It’s been a pleasure to talk with you. And again, I just would encourage our listeners to reach out to us. We do have an enquiries line, we have the TGA website, we have all our social media and it can be a very confusing landscape and we’re here to help. So, please reach out to us if you need to.

Dr Jayne Foster

Wonderful. Thank you. If you'd like more information on the regulation of therapeutic goods, please visit the TGA website at www.tga.gov.au. Or visit our Facebook page, Twitter, YouTube or our blog. If you look under SME Assist on the TGA website, you'll find a range of materials and interactive tools that cover various introductory topics, especially targeted at those new to regulation. You can also find links to other useful resources for businesses and researchers such as access to research facilities and even funding opportunities.

There is also the option to subscribe to the SME Assist email list to stay up-to-date with the latest SME-related information and events from the TGA. If you still have further questions about the regulation of therapeutic goods, please email our team at sme.assist@tga.gov.au.

Thank you for joining us today. In our next episode, we'll be talking Brian Chamberlain who works in TGA's Medical Devices Authorisation branch, to learn about supplying certain therapeutic goods in relation to COVID-19. Please hit subscribe in the Podbean app, or wherever you listen to your podcasts, to ensure you don’t miss it.