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Webinar recording: SME Assist - Supplying and advertising therapeutic goods for COVID-19, 28 May 2020

23 June 2020

Disclaimer

This recording is provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the recording should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the recording.

Recording of online webinar

  • Presented by: Dr Jayne Foster and Melanie Leake
  • Webinar date: 28 May 2020
  • Webinar summary: Information for new sponsors of hand sanitisers, disinfectants and personal protective equipment.

Transcript

Slide 4

Dr Jayne Foster Good afternoon everyone. Before I start, I would like to acknowledge the traditional owners of the land on which we meet here today and pay my respects to their elders, past, present and emerging. I'd also like to welcome any Aboriginal and Torres Strait Islander people who are joining us online today as well.

Just to let you know that today we are providing general information and general advice. The information on these slides is a summary only and should not be taken as law or policy. Make sure you do understand your obligations under our legislation and if you need to, you may need to seek independent third party advice as well.

Slide 5

I'll just talk you through today's objectives, So I'm firstly going to run through the basics of therapeutic goods regulation and the role of the Therapeutic Goods Administration

Melanie is then going to take you through regulation requirements specific to hand sanitisers, disinfectants and Personal Protective Equipment for COVID-19. Please note that we will not be covering all therapeutic goods relating to COVID-19 today, such as test kits.

I will then return and explain market authorisation and your advertising responsibilities.

So our presentation will take approximately 1 hour, we will then take a short 5 minute break, after which we will have a dedicated Q&A session for up to 1 hour where we have a panel of TGA experts who will join us to answer your questions.

Slide 6

As we all know, COVID-19 has been declared a pandemic by the World Health Organization with most countries experiencing cases of COVID-19 and many experiencing outbreaks.

We had our first confirmed case in Australia in January and we are responding to the COVID-19 outbreak as an emergency.

The outbreak has attracted a large number of new businesses into the medical and health fields.

Since 14 February 2020:

  • more than 1500 new organisations have registered their details with TGA and we have
  • processed more than 2,000 applications for medical devices related to COVID-19 to be included in the ARTG
  • received over 1000 enquiries regarding hand sanitisers
  • issued a number of infringement notices for COVID-19 advertising breaches.

Slide 7

TGA continues to prioritise and expedite all applications seeking regulatory approval to import and supply devices for the prevention, detection and treatment of COVID-19.

We have created exemptions and placed appropriate conditions on exemptions to improve access. And these orders will be revoked once the pandemic is declared officially over.

Full regulatory assessments are still occurring and some approvals have been given with conditions based on information available at the time of application.

While we continue to publish information on our website about medicines and medical devices related to COVID-19, the purpose of this webinar is to help new sponsors who have not interacted with TGA before and are unfamiliar with their responsibilities under Therapeutic Goods legislation.

We also hope to reduce the number of non-compliance cases that our Regulatory Compliance Branch is receiving around illegal COVID-19 advertising claims which can put the Australian public at risk.

Slide 8

If you are considering supplying, manufacturing, advertising, importing, and/or exporting a product to help test for, prevent or treat SARS-CoV-2 (COVID-19) then you are a potential sponsor of a therapeutic good. You will have certain responsibilities and will have to meet strict requirements under TGA legislation, such as the Therapeutic Goods Act 1989 in order to avoid civil and criminal penalties associated with non-compliance.

Slide 9

When it comes to therapeutic goods, lots of people can be involved. This image represents the different people who might have a role to play: the consumer (top) uses the therapeutic good. We have the wholesaler, retailer, importer/exporter and manufacturer and also the TGA. You could be any of the characters circled in yellow (and you are also likely to be a consumer).

Slide 10

So first, let's have a look at TGA – who we are and what we do. We are part of the Australian Government Department of Health. We regulate and monitor all therapeutic goods to ensure they are safe and do what they are meant to.

We do this in line with the Therapeutic Goods Act 1989 – which provides a uniform, national system of controls over therapeutic goods. This benefits both consumers and industry.

Slide 11

What do we mean by a therapeutic good? It's broadly defined as something used for:

  • Preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury eg. paracetamol
  • Influencing, inhibiting or modifying physiology (eg., pacemaker)
  • Testing for a disease or ailment (eg., MRI machine)
  • Influencing, controlling or preventing conception (eg., condom)
  • Testing for pregnancy (eg., pregnancy test)
  • Replacing or modifying a part of the anatomy (eg., prosthesis)

We have decision tools on our SME Assist webpage to help you determine whether your product is a therapeutic good, and also the classification of your medical device

Slide 12

It's important to know that the TGA doesn't regulate. We don't regulate veterinary medicines, health professionals, health insurance, food standards, and cosmetic and chemical standards. These are regulated by other federal, state or territory bodies. Note that cosmetics used in surgery (e.g., breast implants and cosmetic injectables) are actually regulated by TGA.

Slide 13

It's also worth noting that we sometimes interact with other regulators, so when you work with us, you may also need to work with others.

We don't research and develop new therapeutic goods, provide clinical advice to individuals, consider cost effectiveness or recommend one product over another, or make decisions about subsidies for therapeutic goods.

Slide 14

When we're assessing your product for market authorisation approval, we use a benefit versus risk approach.

Goods that pose a higher risk of adverse events or are used for more serious diseases (like prescription medicines) are more tightly regulated than those that pose a lower risk (like herbal supplements).

Goods are regulated or classified into categories depending on their level of risk (e.g., Class I medical devices versus Class IIb medical devices).

Each therapeutic good will have different degrees of benefit and risk, but in all cases, benefits MUST outweigh risks.

Medicines are considered low or high risk depending on the claims made about the medicine, what it contains, and the benefits and risks associated with using it.

Similarly, medical devices are classified according to their intended purpose and the level of harm they may pose to users or patients.

Classification takes a number of factors into account, including the degree of invasiveness in the human body, the duration and location of use, and whether the device relies on a source of energy other than the body or gravity.

This is not a definitive list; therapeutic goods are assessed on a case-by-case basis, carefully considering risk versus benefit.

Slide 15

Therapeutic goods generally fall under three categories: medicines, biologicals and medical devices. Let's look at medicines first:

  • Prescription medicines (like antibiotics) require a doctor's prescription
  • Complementary medicines contain herbs, vitamins, minerals, nutritional supplements, homoeopathic and certain aromatherapy preparations (eg., multivitamins, some herbal teas and essential oils)
  • Over-the-Counter medicines can be purchased without a prescription and are not complementary (eg., lozenges and some cold/flu tablets)

Medicines also include vaccines, and blood and plasma.

Slide 16

The second category is biologicals, which are things that are made from or contain human cells or tissues, or live animal cells, tissues or organs. An example is a skin graft between patients.

Slide 17

And medical devices have a physical or mechanical effect on the body or are used to measure or monitor bodily functions. They include instruments like surgical tools, appliances like pacemakers and materials like sterile bandages.

I will now invite Melanie to take you through information on certain types of therapeutic goods for COVID-19.

Slide 18

Melanie Leake Thanks Jayne. Firstly, it's important to point out that some products for COVID-19 may or may not be considered therapeutic goods- these include 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 TGA only regulates therapeutic goods, so it's important to know if you have a therapeutic good or not to understand your regulatory requirements.

We'll now go into this in more detail.

Slide 19

Hand sanitisers are products that contain antiseptic ingredients used on the skin to kill or prevent the growth of microorganisms 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 (e.g., "Kills 99.9% of bacteria"). And they must not contain substances that are included in Schedule 2, 3, 4 or 8 of the Poisons Standard (SUSMP)

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 the COVID-19 pandemic, on 28 March 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 Australian Register of Therapeutic Goods or ARTG and must meet TGA's regulatory requirements.

Slide 20

Provided the exact formulation, manufacturing, labelling and advertising requirements are complied with, ethanol hand sanitisers and isopropyl alcohol hand sanitisers are covered by the Exclusion Determination and permitted for use in both health care settings and for personal consumer use.

The specified formulations are based on advice by the World Health Organization and similar decisions by the US Food and Drug Administration. More information on these specific requirements can be found on the TGA website.

While these products are not subject to therapeutic goods legislation and do not need to be included in the ARTG, they will continue to be regulated as consumer goods under Australian Consumer Law. For more information, you may wish to contact the Australian Competition and Consumer Commission (ACCC).

These products must still meet the advertising requirements of the Exclusion Determination. Advertising includes labelling and packaging.

Slide 21

Hand sanitisers that are regulated as therapeutic goods:

  • make claims to kill specific organisms (such as E.coli or viruses)
  • are to be used in clinics or hospitals
  • are not otherwise captured by the Excluded Goods Determination
  • are regulated as Over-The-Counter (OTC) medicines

Slide 22

Here is some important information on packaging of hand sanitisers. Alcohol-based hand sanitisers and some of their ingredients, are hazardous chemicals. For e.g. hand sanitisers may contain ethanol and isopropanol, which are flammable liquids and can also cause severe eye irritation, and hydrogen peroxide which is an oxidiser and is corrosive to the skin and eyes.

Regardless of whether your sanitiser is regulated as a therapeutic good, an excluded good or a consumer product, you must ensure that you do not package your hand sanitiser in containers that look like food or beverage containers. Avoid foil sachets, pouches with a spout or containers with pop-top lids.

Slide 23

In summary, all therapeutic goods, including hand sanitisers that are determined to be therapeutic goods:

  • must be included in the ARTG
  • are regulated by the TGA as OTC medicines
  • must meet ALL regulatory requirements for OTC medicines

The Australian Regulatory Guidelines for Over-the-Counter Medicines is available and contains all the details you will need to know about what OTC medicine requirements are, including (but not limited to):

  • What supporting documentation you may need (such as evidence of quality and safety)
  • What manufacturing requirements may apply
  • How to apply to have your OTC hand sanitisers included in the ARTG

You need to submit your application through TGA Business Services along with supporting data.

For more information, you can contact the OTC medicines team at otc.medicines@health.gov.au.

Slide 24

In light of the current COVID-19 situation, there is significant interest from potential sponsors and manufacturers around how disinfectants are regulated and how to supply them.
Disinfectants can be:

  • a therapeutic good
  • a general consumer product
  • an exempt disinfectant
  • an excluded good

What disinfectants claim to do will determine how they are regulated by the TGA under the Therapeutic Goods Act 1989. Claims may be made on the labels, instructions for use or on promotional material.

General cleaners and sanitisers that do not make disinfectant claims and:

  • are not for use on medical devices are not regulated by TGA
  • whereas those for use on medical devices are regulated by TGA

Slide 25

How disinfectants are regulated as therapeutic goods, 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, sponges and aerosols that make specific claims and that are:

  • not intended for use internally or on skin
  • not intended for use on a medical device
  • are intended for use on inanimate objects such as hard and soft surfaces (for example curtains, floors, bench tops, lounge furniture and carpets)

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.

Specific and non-specific claims can be found in the disinfectant claim guide.

Slide 26

Exempt disinfectants are not required to be included in the ARTG before they are supplied to the market 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 skin
  • not intended for use on a medical device
  • are intended for use on inanimate objects such as hard and soft surfaces (e.g. curtains, floors, bench tops, lounge furniture and carpets)

Virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity are known as 'specific claims'. More information can be found in the Disinfectant Claim Guide.

An overview of how products commonly known as disinfectants and sterilants are defined and regulated can be found on the TGA website.

Slide 27

When making new label claims against microorganisms, including COVID-19, the disinfectant must be compliant with the relevant requirements of Chapter 3 of the Therapeutic Goods Act, the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019, the Therapeutic Goods (Prohibited Representations-Disinfectants) (COVID-19) Permission 2020 and the TGA instructions for disinfectant testing.

You should also follow the TGA's advice on the use of surrogate viruses for COVID-19 for efficacy testing.

If you wish to make label claims of efficacy against COVID-19 for products that are either hard surface disinfectants or disinfectants that are medical devices, the following surrogate viruses can be used:

  • Human coronavirus 229E
  • Murine hepatitis virus

In the event that either Human coronavirus 229E or Murine hepatitis virus cannot be used, consideration will be given to use of other human or animal coronaviruses. Viruses that have been suggested include Bovine coronavirus and Feline coronavirus.

If coronaviruses other than the specified surrogates are to be used, please contact TGA.

Slide 28

Disinfectants as Excluded goods are products, which are excluded from TGA regulation.

While they may be required to meet relevant legislative requirements under consumer legislation, they are not required to meet any of the legislative requirements under TGA.

The following products are excluded from regulation under different legislative mechanisms:

  • 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

Slide 29

To summarise - Disinfectants, which are therapeutic goods:

  • are regulated as listed disinfectants, Class I and Class IIb medical devices
  • must meet the regulatory requirements for medical devices and their specific classification
  • specific and non-specific claims can be found in the disinfectant claim guide

Applications are submitted as shown on the slide (Device/OTG>Other>Therapeutic Good – Listed). Guidance for these applications can be found in the Australian Regulatory Guidelines for Medical Devices or ARGMD. You can also contact the devices team at devices@health.gov.au.

Note that all COVID-19 related applications are being expedited.

Slide 30

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 these are 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 31

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 low risk, Class I medical devices
  • when supplied as sterile, they will be considered Class I 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 IIa medical devices

Slide 32

If supply levels of PPE during COVID-19 become critically low and there are no alternative options, it may be necessary to reprocess single use PPE to make them suitable for reuse.

Reprocessing of PPE involves using a series of validated and tightly controlled steps, including cleaning and/or decontamination to inactivate all potentially harmful organisms.

Many single use products are not suitable for reuse and some methods of decontamination may not be fully effective, which could expose patients and medical staff to unnecessary risks.

It is recommended that only decontamination systems that are approved as medical devices for the decontamination of certain types of PPE (such as respirators) are used for this purpose.

Slide 33

Due to a rapid increase in demand for the manufacturing, importation and sale of COVID-19 related products, there has been an increase in medical device inclusions in the ARTG, many of which are manufactured and imported from overseas.

Some of these products do meet the definition of a medical device and must be included in the ARTG before they are supplied.

Some of these products do not meet the definition of a medical device although they may still be used to prevent the spread of diseases, including COVID-19 but they do not need to be included in the ARTG

Some of these products do not meet the definition of a medical device but do need to be included as an OTC medicine, such as some hand sanitisers with specific claims that are used in health facilities.

All class I medical devices that are auto included in the ARTG without pre market scrutiny are assessed for correctness in the post market space

A number of concerns have been raised about the quality and effectiveness of some of these products, particularly face masks, including that they:

  • are included in the ARTG but do not meet the legislative requirements for medical devices; or
  • may not, or do not, perform as intended.

TGA is undertaking a post-market review of COVID-19 related devices that are included in the ARTG to ensure they meet regulatory requirements and perform as intended These devices are also the subject of routine post market scrutiny and sponsors regulatory obligations. So, again, it's really important that you determine if your product meets the definition of a medical device - if so you should ensure that it is included in the ARTG and you have the required evidence before you import and/or supply it.

For example the information required with respect to the post market review of class I masks includes:

  • declaration of conformity
  • a list of models of masks, supply numbers by model and year (if applicable), and the states within Australia where you have distributed the face masks
  • details of the manufacturing standards the devices conform to and evidence of compliance
  • a copy of all packaging and labelling
  • a copy of the Instructions for Use that are supplied with your product (if applicable)
  • where the intended purpose of the device claims to protect the wearer from COVID-19, either specifically or by implication, appropriate evidence to support such a claim (such as evidence from a clinical trial, or testing from an accredited laboratory to a recognised standard)

TGA will be publishing any regulatory or other action taken against individual products as a result of the review on the website

Slide 34

In summary when regulated as therapeutic goods, PPE:

  • are generally regulated as a Class I, Class Is (sterile) or Class IIa medical device
  • 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 not alternatives available

For further information refer to the COVID-19 page of the TGA website on reuse of face masks and gowns.

Again, if an application relates to COVID-19, these are being expedited. Guidance for these applications can be found in the ARGMD and you can also contact the devices team at devices@health.gov.au.

Slide 35

Just a reminder that TGA only regulates therapeutic goods.

Product safety regulation in Australia for general consumer products is a shared responsibility between the ACCC and the states and territories. The three Government organisations shown on the slide can assist with the regulation of non-therapeutic goods. Visit their websites for more information on what they regulate to find where your product sits.

I will now hand back over to Jayne.

Slide 36

Dr Jayne Foster Thanks Melanie. So now you have determined that you have a therapeutic good, let's look at how you supply your therapeutic good in Australia.

This is a general overview, the market authorisation process will differ depending on what type of therapeutic good you have and it's classification (whether it's a Medical device Class I or an Over-The-Counter medicine for example).

Differences include but are not limited to:

  • Fees and charges
  • Evidence of efficacy requirements
  • Evidence of safety and quality requirements

Advertising and manufacturing will also have different requirements depending on your type of therapeutic good.

Slide 37

Here is an overview of a therapeutic good development lifecycle to show you how different regulatory stages fit together

Market authorisation is the approval process to supply your product and it consists of three stages.

  1. In the pre-market stage, you compile data and information about your product and include any clinical data you have collected. If you have a low risk medicine, like a listed complementary medicine, you don’t need to provide clinical data with your application (but you must hold evidence to back any claims you make about your product and provide it later if we ask)
  2. In the processing stage, you submit your application online and attach the data and information you compiled in the pre-market stage
  3. If your application is successful, you move to the post-market stage where you have ongoing responsibilities to maintain your market authorisation

For some products, you may be able to make applications to the Department for subsidy in parallel with your application to TGA for market authorisation.

However, no pharmaceutical, prosthesis or Medicare listing will occur until the product is included in the ARTG. For more information, visit the Pharmaceutical Benefits Scheme website, the Prostheses List Advisory Committee website or the Medical Services Advisory Committee website.

And remember that TGA approval does not mean that your product will be subsidised.

Slide 38

Market authorisation is required before you can supply a therapeutic good in Australia.

Supply is not only the sale of a product. It also includes: exchange, gift, lease, loan, hire or hire purchase so things like a free sample, leasing a dentist drill, and hiring out crutches all need market authorisation.

If you want to: manufacture, import or export therapeutic goods or arrange for any of these, you will need to apply for market authorisation.

Slide 39

If you are interested in manufacturing or supplying medicines or medical devices in response to the COVID-19 pandemic, you need to meet all the regulatory requirements and these are outlined in the relevant Australian Regulatory Guidelines document.

For e.g., the Australian Regulatory Guidelines for OTC Medicines (ARGOM) or the Australian Regulatory Guidelines for Medical Devices (ARGMD).

These guidelines are specific to the type of therapeutic good and are updated regularly.

They contain further details on what is required for market authorisation and other legislative requirements specific to your therapeutic good.

You will also need to consult the ARGATG for your advertising responsibilities.

Note that these are guidance only and the relevant part of the legislation is the definitive source of information.

Slide 40

You can find the Australian Regulatory Guidelines are located under the 'Industry' tab on the TGA website.

The different types of therapeutic goods are listed underneath – select Standards and guidelines and you'll find the relevant Guidelines there.

Slide 41

Once you've obtained market authorisation, you're known as the sponsor.

The sponsor bears all responsibilities and is financially liable for the therapeutic good. This is the case even if there are multiple people working on different stages of manufacture in different countries.

And remember, the sponsor has ongoing responsibilities even after approval has been given.

Slide 42

When market authorisation is granted, the product is added to the ARTG. This an online database on the TGA website where you can search using key words.

It's always a good idea to search the ARTG to see similar products that are being supplied

Slide 43

Each ARTG entry is unique in some way, or 'separate and distinct'.

This uniqueness depends on the type of therapeutic good you have. You will need to look at the definition in the legislation that is relevant to your product.

For example, if we have an OTC medicine and another OTC medicine that is exactly the same, but it has a different name, or different indications or different dosage, that product is considered 'separate and distinct', and will have its own ARTG entry.

You can find more specific information in the relevant legislation, this example does not cover all considerations that make a therapeutic good 'separate and distinct'.

Slide 44

Sponsorship can happen in lots of different ways. We'll now go through an example of a multiple sponsor scenario.

Here we have a therapeutic good. Let's say it's an OTC medicine. John from Victoria would like to import this good for supply in Australia, so he applies for and obtains market authorisation through TGA.

This therapeutic good, in its exact, identical form, can only have 1 sponsor. Meanwhile, Anna from WA is interested in supplying the same product. She has two options:

  • She can contact John to see if she can be a wholesaler or retailer of the good. She has to get permission from him. Note, that there could be commercial agreements in place that may not allow this, and John is under no obligation to have a commercial arrangement with Anna. OR
  • She can choose to sell the medicine under a different brand name, making the product SEPARATE and DISTINCT. In this case, she must apply for market authorisation herself.

Slide 45

TGA Business services, otherwise known as TBS is the online portal available to sponsors. This is where you submit and manage your applications and every sponsor needs an account.

Slide 46

You can find the TGA Business Services Portal under the 'About the TGA' tab.

Slide 47

TGA recover its costs through fees and charges for activities that fall within the scope of the Therapeutic Goods Act.

As a sponsor of a therapeutic good, you will be required to pay fees and charges that apply to your good. Fees are for a service while Charges are an annual tax.

All therapeutic goods on the ARTG are subject to annual charges (except export only products and products that fall under the Annual Charge Exemption scheme). We encourage you to look at the link to fees and charges so you know what to expect.

Slide 48

The Annual Charge Exemption (or the ACE) scheme allows for exemption of annual charges until a product first generates turnover.

All new entries on the ARTG are eligible. Sponsors need to make a declaration each year confirming $0 turnover.

Note that fees are not included in the ACE scheme (only charges).

Slide 49

Fees and charges can also be found under the 'About the TGA' tab.

Slide 50

Manufacturing involves many steps. If you are involved in producing a therapeutic good, or any part of the production of a therapeutic good – you are involved in manufacturing.

There are differences in manufacturing requirements for different types of therapeutic goods:

Good manufacturing practice (or GMP) describes a set of principles and procedures that ensure the manufacture of medicines and biologicals are consistent and of high quality.

GMP is based on principles that:

  • quality cannot be tested into a batch of product
  • quality must be built into each batch of product during all stages of the manufacturing process

Conformity assessment is how a manufacturer demonstrates a medical device or in-vitro diagnostic or IVD (and the process to manufacture it) meets safety, quality and performance requirements.

The level of conformity assessment required matches the level and nature of the risks associated with the use of the device. Self-assessment by the manufacturer is acceptable for low risk devices, whereas for the highest risk devices an assessment of the manufacturer's quality management system and examination of the design of the specific device by a conformity assessment body is required.

Slide 51

If you are interested in manufacturing or supplying medicines or medical devices, you must meet all the regulatory requirements.

Again, these are outlined in the relevant Australian Regulatory Guidelines document.

Slide 52

For more information regarding manufacturing, please view the TGA website.

There are many pages dedicated to understanding manufacturing requirements, GMP and conformity assessment.

Slide 53

TGA's work continues over the lifetime of every therapeutic good, from manufacturing through to adverse events. Ongoing monitoring of therapeutic goods is an important part of ensuring safety, efficacy and quality of therapeutic goods used in Australia.

Now your therapeutic good is included in the ARTG, you as the sponsor have ongoing legal responsibilities associated with that good.

These responsibilities include but are not limited to:

  • obtaining information from the manufacturer and providing this to TGA upon request
  • ensuring that the product's manufacturer meets the relevant regulatory requirements
  • paying any ongoing charges associated with maintaining the ARTG entry
  • notifying or requesting changes to the therapeutic good if necessary
  • complying with any conditions imposed on supply or advertising of the good
  • recording supply of the good
  • notifying TGA of adverse events and adverse reactions associated with the sponsored good
  • advising TGA of the need to recall a product
  • recalling the product, if necessary

If you do not meet these requirements, both civil and criminal penalties might apply. See our Compliance and enforcement hub for more detail.

Slide 54

We monitor, and enforce where necessary, compliance with legislation, regulations and rules for therapeutic goods.

Our regulatory compliance functions support consumer protection and enable a fair market for industry. We promote high levels of voluntary compliance through engagement and education.

Slide 55

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

So what is advertising?

Advertising is considered as any promotional material. It includes things like (but not limited to): Labels on your medicine (this includes packaging), TV advertisements Websites, including Social media sites.

Slide 56

Advertising is regulated by the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 and Therapeutic Goods Advertising Code. Advertisements also need to comply with other relevant laws (e.g. the Competition and Consumer Act 2010).

The Act prohibits, among other things:

  • the promotion of therapeutic goods that are not on the ARTG when they should be
  • the use of 'prohibited representations' – such as references to cancer
  • and the unapproved use of 'restricted representations' – such as references to 'serious' diseases and conditions, like COVID-19.

The Act also requires advertisers to comply with the Advertising Code. The Code regulates what can and can't be said when advertising therapeutic goods. It covers definitions and general requirements including accuracy, scientific or clinical representations, endorsements, testimonials. We have Code guidance available to help advertisers interpret the Advertising Code.

So why do we regulate advertising?

We regulate advertising because not only can a false claim be misleading, it can be unsafe! Advertising must not be socially irresponsible, mislead or deceive the consumer. Before you advertise therapeutic goods, it is your responsibility to understand the legislative requirements.

Slide 57

You must pay attention to what claims you make and how they may be directly or indirectly perceived by the average consumer. As COVID-19 is a serious condition (considered therefore a restricted representation), it will need prior approval from the TGA before you can make any reference to it in your advertising. Any claims and representations referring to SARS-CoV-2 or COVID-19 must:

  • have prior approval before their use, as you cannot reference prohibited or restricted representations
  • be included in the ARTG entry of your goods
  • not be misleading
  • And you must have appropriate evidence to support any claims you make

TGA takes illegal advertising claims seriously and can and will penalise sponsors who put consumer's at risk of harm.

Slide 58

Advertising is your responsibility. The Therapeutic Goods Act and the Advertising Code apply to all therapeutic goods to varying degrees. The Advertising Code outlines key requirements that must be met when advertising to the public. Familiarise yourself with this legislation to understand what you can and cannot do. Make sure you are aware of what your labels, or any advertisement says – are you being misleading? Do you hold evidence that your product can be used in the way you are suggesting? Don't wait until a complaint comes through to TGA from the public, or we audit you to be compliant. You can make changes at any time to correct mistakes. We have lots of guidance material and contacts available to help you to understand the Code requirements. You can find these under the Advertising hub.

Slide 59

Again, you can find the Advertising hub under the 'About the TGA' tab.

Slide 60

You can find further help via SME Assist. SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), start-ups and researchers who are developing new medicines and medical devices understand their regulatory and legislative obligations. Our team runs workshops in major cities around Australia which cover the basics of regulation, market authorisation, manufacturing, advertising and post-market monitoring.

We live streamed and recorded our last workshop in Sydney, and we also have pre-recordings of our workshop topics. You can find all of these on the TGA website under SME Assist - Presentations and webinars.

We encourage you to subscribe to our SME Assist email list to stay up to date with the latest SME information including upcoming workshops, new guidance and webinars. You can also contact the SME Assist team via the details shown on this slide.

Slide 61

We also encourage you to visit our various social media sites.

Slide 62

Thanks very much everyone for your attention throughout this presentation and again, our apologies for those technical difficulties experienced at the start. We will now take a short 5 minute break and then regroup for our question and answer session where you will have the opportunity to ask questions of TGA staff. We would appreciate if you could answer a few poll questions about today’s presentation during the break. Thank you.

Slide 63

Welcome back everyone, we will now have representatives from Medical devices (both pre and post market), Over-The-Counter medicines and Advertising joining us for the Q&A session.

Keep in mind that questions should be general in nature. We have reviewed all of your pre-submitted questions and felt that many of these have been addressed throughout the presentation. If you still have questions, you can submit these now. If we don't address your question in this session, please email SME Assist and we will do our best to answer your enquiry or liaise with the relevant area in TGA.

I'll now hand you over to Mel to facilitate the question and answer session.

Note that we have not provided a transcript of the Q and A session. Please advise SME Assist on 1800020653 or email sme.assist@tga.gov.au if you experience any accessibility issues.