TGA presentation: Supplying and advertising …...Supplying and advertising certain therapeutic...

Supplying and advertising certain therapeutic goodsfor COVID-19Information for new sponsors of hand sanitisers, disinfectants and personal protective equipment

Regulatory Engagement, Education and Planning Branch

28 May 2020

Dr Jayne FosterSME Assist

Melanie LeakeSME Assist

Welcome!•

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Supplying and advertising certain therapeutic goods for COVID-19 2

DisclaimerThis material is provided to you solely for the purpose of providing a record of today’s presentation.

The presentation is 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 presentation should not be relied upon in any way as representing a comprehensive description of

regulatory requirements, and b) it cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or

completeness of the information contained in the presentation


Objectives of today’s WebinarAs a new or potential sponsor of a therapeutic good, this webinar helps you to understand:•••

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the basics of therapeutic goods regulationthe role of the Therapeutic Goods Administration (TGA)regulation requirements specific to hand sanitisers, disinfectants and Personal Protective Equipment (PPE) for COVID-19your advertising responsibilities

You will also have the opportunity to ask questions of TGA staff in the interactive question and answer session that will follow the presentation

Supplying and advertising therapeutic goods for COVID-19 4

Coronavirus (COVID-19 or SARS-CoV-2)•

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First confirmed case in Australia in late January 2020

The Department of Health is responding to the COVID-19 pandemic in Australia as

a health emergency

Since 14 February 2020, TGA has:

processed over 1500 new organisation forms from new sponsors

processed over 2000 applications for medical devices for personal protective

equipment (e.g. surgical face masks, protective eyewear, gloves and gowns),

COVID-19 test kits, ventilators and disinfectants

received over 1000 enquiries regarding hand sanitisers

issued a number of infringement notices for COVID-19 advertising breaches

Supplying and advertising certain therapeutic goods for COVID-195

TGA’s response•

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We are prioritising and expediting 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

Full regulatory assessments are still occurring

Some approvals given with conditions based on information available at the time of application

We continue to publish the latest information about medicines and medical devices related to

COVID-19 on our website (https://www.tga.gov.au/collection/covid-19


https://www.tga.gov.au/collection/covid-19

Where to start•

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If you are looking to: supplymanufactureadvertiseimport export

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 need to meet certain requirements under the Therapeutic Goods Act 1989 (the Act) Civil and criminal penalties may apply if you do not meet your legal requirements


8Supplying and advertising therapeutic goods for COVID-19

The role of TGAWe regulate and monitor all therapeutic goods in Australia to ensure that they are safe to use and fulfil their intended purpose.

It is our mandate to fulfil this service, as set out by the Therapeutic Goods Act 1989.


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https://www.legislation.gov.au/Series/C2004A03952

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Something used for:

Preventing, diagnosing, curing or alleviating a disease, ailment, defect or injuryInfluencing, inhibiting or modifying a physiological processTesting the susceptibility of persons to a disease or ailmentInfluencing, controlling or preventing conceptionTesting for pregnancyReplacing or modifying a part of the anatomy


We regulate therapeutic goods

What we do NOT regulate

VETERINARY MEDICINES

States and Territories and

Food Standards Australia New

Zealand(FSANZ)

Australian Health

Practitioner Regulation

Agency(AHPRA)

Australian Prudential Regulation Authority (APRA)

Australian Pesticides and

Veterinary Medicines Authority(APVMA)

National Industrial

Chemicals Notification and

Assessment Scheme

(NICNAS)

HEALTH PROFESSIONALS

HEALTH INSURANCE

FOODSTANDARDS

COSMETIC AND CHEMICAL

STANDARDS


We don’t:

Research and develop new

therapeutic goods

Provide clinical advice to

individuals

Consider cost effectiveness or recommend one

product over another

Make decisions about subsidies for therapeutic

goods


Benefit versus risk••

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Therapeutic goods are regulated based on the level of risk they pose Goods that pose a higher risk of adverse events or are used for more serious illnesses are more tightly regulated than those that pose a lower riskMedicines and medical devices are classified according to risk depending on:

what they contain what they claim to do the duration and location of their use the benefits and risks associated with their use

Benefits have to outweigh risks!


https://www.tga.gov.au/registered-and-listed-medicines

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Medicinesthese include:

Prescription medicinesComplementary medicinesOver-the-counter medicinesVaccinesBlood and plasma


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Biologicalsthings that are made from or contain:

Human cells or tissuesLive animal cells, tissues or organs


Medical devicesthese generally have a physical or mechanical effect on the body or are used to measure or monitor functions of the body

They include instruments, appliances and materials


Therapeutic goods for COVID-19•

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Hand sanitisers, disinfectants and personal protective equipment for COVID-19 may or may not be considered therapeutic goods

In response to the pandemic, TGA has excluded some products (e.g. certain types of hand sanitisers) from being therapeutic goods

TGA only regulates therapeutic goods so it’s important you determine if your product is a therapeutic good to understand if your product falls under this legislation


https://www.tga.gov.au/collection/covid-19

Hand sanitisers•

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Hand sanitisers:contain antiseptic ingredients used on the skin to kill or prevent the growth of microorganismscan be either hand washes for use with water or hand rubs for use without watermay not be therapeutic goods, some are considered cosmetics because they meet specific requirements (low level, general claims and formulation) may be excluded from TGA regulations because they meet specific requirements in the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determinationthat are therapeutic goods must be included in the ARTG and meet regulatory requirements


Hand sanitisers as excluded goods•

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Provided the exact formulation and manufacturing, labelling and advertising requirementsare complied with, the following products are covered by the Exclusion Determination and permitted for use in both health care settings and for personal consumer use:

ethanol hand sanitisersisopropyl alcohol hand sanitisers

The specified formulations are based on advice by the World Health Organization and similar decisions by the US Food and Drug AdministrationAlthough not subject to therapeutic goods legislation, these products:

are regulated as consumer goods under Australian Consumer Lawmust still meet the advertising requirements of the Exclusion Determination


Hand sanitisers as therapeutic goodsHand sanitisers that are regulated as therapeutic goods:

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make claims to kill specific organisms (e.g. E.coli) or viruses, and/orare to be used in clinics or hospitalsare not otherwise captured by the Excluded Goods Determinationare regulated as Over-The-Counter (OTC) medicines

20Supplying and advertising certain therapeutic goods for COVID-19

Packaging of hand sanitisers•

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Alcohol-based hand sanitisers and some of their ingredients, are hazardous chemicals

If you manufacture or import hand sanitisers, you must meet specific packaging and labelling requirements

Do not package your hand sanitiser in containers that are likely to be mistaken for food or drink

avoid foil sachets, pouches with a spout or containers with pop-top lids


Summary - Hand sanitisers as therapeutic goods

Contact OTC medicines: [email protected]

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Must be included in the Australian Register of Therapeutic Goods (ARTG)

Are regulated as Over-The-Counter (OTC) medicines by TGA

Must meet all regulatory requirements for OTC medicines including labelling and packaging

See the Australian Regulatory Guidelines for Over-The-Counter Medicines (ARGOM) for

guidance

Applications are submitted through TGA Business Services along with supporting data


mailto:[email protected]

Disinfectants•

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May be used on medical devices or for household or commercial purposesAre regulated in a variety of ways depending on the intended purpose, which is determined by claims, labelling and other advertising materialMay be a therapeutic good, a general consumer product, an exempt disinfectant or an excluded good

Products that claim they kill, or are active against, viruses, spores, tuberculosis, mycobacteria or fungi (i.e. making ‘specific claims’) are therapeutic goodsGeneral cleaners and sanitisers that do not make disinfectant claims and:

are not for use on medical devices are not regulated by the TGAare for use on medical devices are regulated by the TGA


https://www.tga.gov.au/disinfectants-sterilants-and-sanitary-products

Disinfectants as therapeutic goods

Intended use Claim Regulated

Cleaners on medical devices Do not claim to be a device disinfectant or sterilant

Class I medical devices

Liquids, sprays, wipes and aerosols

on medical devices Do make disinfectant or sterilant claims

Class IIb medical devices

Hard surface disinfectants

hospital grade, household or commercial grade disinfectant liquids, sprays, wipes, sponges and aerosols

Make specific claims that a product kills, or is active against, viruses, spores, tuberculosis, mycobacteria or fungi

‘Listed disinfectants’ which are Other Therapeutic Goods (OTG)


https://www.tga.gov.au/publication/disinfectant-claim-guide-specific-claims-and-non-specific-claims

Exempt disinfectants•

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These products are not required to be included in the ARTG but they must still meet all TGA regulatory requirements as set out in the relevant legislation and guidanceHard surface disinfectants:

such as hospital grade, household or commercial grade disinfectant liquids, sprays, wipes, sponges and aerosols that do not make specific claims that a product kills, or is active against, viruses, spores, tuberculosis, mycobacteria or fungi

do not require inclusion on the ARTG, but must meet all regulatory requirements for exempt disinfectants


https://www.tga.gov.au/disinfectants-sterilants-and-sanitary-products

Claims for disinfectants•

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When making new label claims against microorganisms, including COVID-19 (if permitted), the disinfectant must be compliant with the:

relevant requirements of Chapter 3 of the Therapeutic Goods Act 1989 Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019Therapeutic Goods (Prohibited Representations-Disinfectants) (COVID-19) Permission 2020 TGA instructions for disinfectant testing

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

Human coronavirus 229EMurine hepatitis virus

If Human coronavirus 229E or Murine hepatitis virus cannot be used, consideration will be given to the use of other human or animal coronaviruses with an appropriate justification


https://www.tga.gov.au/publication/tga-instructions-disinfectant-testing

https://www.tga.gov.au/surrogate-viruses-use-disinfectant-efficacy-tests-justify-claims-against-covid-19

https://www.legislation.gov.au/Details/F2019L00482

Disinfectants as excluded goods•

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These products are excluded from regulation by the TGA by the Therapeutic Goods (Excluded Goods) Determination 2018 and the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011While they may be required to meet relevant legislative requirements under consumer legislation, they are not required to meet any of the legislative requirements under the TGAThe following products are excluded from regulation:

disinfectant and sterilant gasesproducts represented to be for antifungal use onlya disinfectant or sanitiser registered under the Agricultural and Veterinary Chemicals Code Act 1994 which only makes claims and representations registered for the disinfectantdisinfectants or sanitisers that are represented to be suitable for the treatment of drinking water onlycontact lens care products


Summary - disinfectants as therapeutic goods•

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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 a Device/OTG>Other Therapeutic Good – Listed

See the Australian Regulatory Guidelines for Medical Devices (ARGMD) for guidance

Contact medical devices:[email protected]



https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd

Personal Protective Equipment (PPE)•

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PPE is designed to protect the wearer from injury or the spread of infection or illness

The presentation and claims you make determine if your product is regulated as a therapeutic good or a consumer product

PPE which are excluded from regulation under the Therapeutic Goods (Declared Goods) Order 2019 and regulated as consumer products, include those that:

are non-sterileare designed as safety or protective apparel do not claim to be for surgical, medical or therapeutic purposes


https://www.tga.gov.au/new-therapeutic-goods-declared-goods-order-2019

PPE as therapeutic goods•

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PPE are regulated as therapeutic goods when they:are to be for therapeutic use, such as being labelled for clinical or surgical use, and/orclaim to reduce or prevent the transmission of disease or micro-organisms such as bacteria or viruses

These are likely to be regulated as:Class I medical devices – if supplied as non-sterileClass Is (sterile medical devices) - if supplied as sterile, requires manufacturer’s evidence to be submitted to demonstrate sterility aspects have been metClass IIa medical devices – if for use in a setting that is surgically invasive to the body, e.g. surgical gloves


Reprocessing of single use PPE•

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During COVID-19, it may be necessary to reprocess single use PPE to make them suitable for reuse

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 approved as medical devices for the decontamination of certain types of PPE, (e.g. respirators) are used for this purpose


https://www.tga.gov.au/behind-news/reuse-face-masks-and-gowns-during-covid-19-pandemic

Post-market review of COVID-19 devices••

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TGA is undertaking a post-market review of COVID-19 related devices that are included in the ARTGSome of these products:

do meet the definition of a medical device and must be included in the ARTG before they are supplieddo not meet the definition of a medical device and do not need to be included in the ARTGdo not meet the definition of a medical device and do need to be included as OTC medicine

The review will ensure devices included in the ARTG meet all regulatory requirements and perform as intendedAll class I medical devices that are auto included in the ARTG without pre market scrutiny are checked for correctness Ensure you have the required evidence available to support claims, safety and performance to provide to TGA when requested as part of the post-market reviewAny regulatory or other action taken against individual products will be published on the TGA website


Summary - PPE as therapeutic goods

Contact for medical devices:[email protected]

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Generally regulated as a Class I, Class Is (sterile) or Class IIa medical devices

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

See the Australian Regulatory Guidelines for Medical Devices (ARGMD) for guidance




Other Australian Government regulators

For information on the regulation of non-therapeutic goods you may wish to contact:

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Australian Competition and Consumer Commission (ACCC)

www.accc.gov.au

National Industrial Chemical Notification and Assessment Scheme (NICNAS)

www.nicnas.gov.au

Australian Pesticides and Veterinary Medicines Authority (APVMA)

www.apvma.gov.au


http://www.accc.gov.au/

http://www.nicnas.gov.au/

http://www.apvma.gov.au/

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Supplying therapeutic goodsNow you have determined you have a therapeutic good:

learn about market authorisation to include your therapeutic good on the ARTG

create an account through our TGA Business Services (TBS) portal

be aware of your new responsibilities as a sponsor of a therapeutic good

understand manufacturing requirements

get your advertising right to avoid complaints and compliance issues


Therapeutic good development lifecycle


Subsidy

Clinical trial

design, funding

Clinical trial notification / exemption

Pre-market Processing Post-market

TGA Pre-TGA Dept Health

Get approval to supply your product

(‘market authorisation’)

Subsidy*

Make your product moreaffordable

for consumers

Design andget approval to run clinical

trials

Get approval to use your product in

clinical trials

*subsidisation is not guaranteed and will not be granted prior to ARTG inclusion36

https://www.tga.gov.au/sme-assist/overview-applying-market-authorisation

Market authorisationThe approval given to supply*a therapeutic good in Australia*sale, exchange, gift, lease, loan, hire or hire purchase

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If you want to do one or more of the following:manufacture therapeutic goods for supply within Australia or elsewhereimport therapeutic goods into Australiaexport therapeutic goods from Australiaarrange for the import, export or manufacture of therapeutic goods

… you will need to apply for market authorisationthrough the TGA.


http://www.tga.gov.au/sme-assist/overview-applying-market-authorisation

Australian Regulatory Guidelines•

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All types of therapeutic goods have their own Australian Regulatory Guidelines to assist applicants and sponsors with the process of applying for market authorisationNote that these are guidance documents only

ARGOM for over-the-counter medicinesARGMD for medical devicesARGPM for prescription medicinesARGS for sunscreensARGCM for complementary medicinesARGB for biologicalsARGATG for advertising therapeutic goods


https://www.tga.gov.au/publication/australian-regulatory-guidelines-otc-medicines-argom-0


https://www.tga.gov.au/publication/australian-regulatory-guidelines-advertising-therapeutic-goods-argatg

Finding the Australian Regulatory Guidelines

www.tga.gov.au

Industry

Product type

Standards & guidelines


Market authorisation

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Once you’ve obtained market authorisation, you become known as the sponsorThe sponsor bears all associated responsibilities and is financially liable for the therapeutic good

Sponsor

Remember, you will have ongoing responsibilities even after approval has been given. It is a continuous process.


https://www.tga.gov.au/role-sponsor

Australian Register of Therapeutic Goods (ARTG)•

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When market authorisation is granted, the product is added to an electronic registerof therapeutic goods that can be lawfully supplied in Australia – the ARTGIt provides information such as the product name, active ingredients, classification and manufacturerThe ARTG entry is under the sponsor’s name


https://www.tga.gov.au/australian-register-therapeutic-goods

Separate and distinct products have their own ARTG entry

Product type Where to look Section

Medicines

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Therapeutic Goods Act 1989 16

Biologicals Therapeutic Goods Regulations 1990 11A

Medical devices Therapeutic Goods Act 1989 41BE

Every ARTG entry is unique (separate and distinct)This ‘uniqueness’ is defined in a certain way depending on what type of therapeutic good you haveThese definitions can be found in the legislation:



https://www.legislation.gov.au/Series/F1996B00406


Sponsorship example


TGA Business Services The TGA’s online system where you submit and manage your applications including:

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apply for market authorisationsubmit clinical trial notificationsadvise us of adverse events view, cancel or transfer your current ARTG entries and generate certificatespay/review invoicesupdate your details

Every sponsor needs to have an account


https://www.tga.gov.au/tga-business-services

Finding TBS on the TGA website

www.tga.gov.au

About the TGA

TGA Business Services


http://www.tga.gov.au/

Fees and charges•

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TGA is required to recover its costs through fees and charges for a majority of activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities

FeesFor a service e.g.

applicationproduct evaluationauditcertificatesadvertising approval

ChargesLevied annually as a tax on regulated goods and organisationsProduct charges are payable by 15 SeptemberManufacturing licence charges are payable by 1 OctoberNon-payment of charges may result in the cancellation of goods or licences


https://www.tga.gov.au/schedule-fees-and-charges

Fees and charges

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Allows for the exemption of annual charges until a product first generates turnover All new entries are eligible Sponsors are to make a declaration each year to confirm that their entry had $0 turnover in the previous financial year and have never previously made revenue

Annual Charge Exemption (ACE) scheme


https://www.tga.gov.au/annual-charge-exemption-scheme

Finding fees and charges on the TGA website

www.tga.gov.au

About the TGA

Fees and payments

Schedule of fees and charges



Manufacturing•••

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Manufacture is not only making tablets or putting a medical device together Many parts of the process are considered manufacturing, such as the packaging and labelling stepsIf you are producing a therapeutic good, or are involved in any part of production of the therapeutic good, you are involved in manufacture

There are differences in manufacturing requirements depending on the type of therapeutic good you have, for example:

Good Manufacturing Practice (GMP) for medicinesConformity assessment for medical devices


https://www.tga.gov.au/manufacture-therapeutic-goods

Manufacturing during COVID-19

If you are interested in manufacturing or supplying medicines or medical devices,

you must meet all the regulatory requirements. These are outlined in the

relevant Australian Regulatory Guidelines document


Finding manufacturing on the TGA website

www.tga.gov.au

Industry

Manufacturing therapeutic goods

Manufacturing basics



Our work is ongoing

Our work doesn’t stop when a

product reaches the market

It continues over the lifetime of

every therapeutic good

MANUFACTURING MARKETING

ADVERSE EVENTS

HAZARDS

We regulate therapeutic

goods throughout

their lifecycle in a number of

ways.SUPPLY


Regulatory compliance framework

We use a range of compliance and enforcement tools to address alleged non-compliance and to encourage compliance with the Act


https://www.tga.gov.au/hubs/compliance-and-enforcement/compliance-management

Advertising therapeutic goods

Advertising is any promotional material:


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Regulation of therapeutic goods advertising

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A false claim can be misleading to the public and this can be unsafe

Before you advertise therapeutic goods, it is your responsibility to understand the legislative requirements

Advertising is regulated by the:– Therapeutic Goods Act 1989– Therapeutic Goods Regulations 1990– Therapeutic Goods Advertising Code (No. 2) 2018 (the Code)– other relevant laws (e.g. the Competition and Consumer Act 2010)

Supplying and advertising therapeutic goods for COVID-19 55


Making claims and COVID-19COVID-19 is a serious condition Claims and representations that refer to SARS-CoV-2 or COVID-19:

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are either prohibited or restricted representations and cannot be used without prior authorisation from TGAmust be included in the ARTG entry for the advertised therapeutic good must not be misleadingmust be supported by appropriate evidence

Illegal COVID-19 advertising claims are of significant concern to the TGA. Companies who put consumers at risk may receive criminal or civil penalties



Supplying and advertising therapeutic goods for COVID-19

• Advertising requirements vary according to the type of therapeutic good

• Familiarise yourself with the relevant sections of the Act and the Code

• Make sure you have supporting evidence to back up all of your claims and indications

• Don’t wait until a complaint or post-market review of your advertising to be compliant

• If in doubt, we have resources for you – visit the Advertising hub on the TGA website

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Advertising is your responsibility

https://www.tga.gov.au/advertising-advertising-code-and-guidance

Finding the advertising hub on the TGA website

www.tga.gov.au

About the TGA

Advertising hub

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https://www.tga.gov.au/advertising-hub

Finding help - SME Assist•

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Targets the needs of small to medium enterprises (SMEs), start-ups, researchers and those unfamiliar with therapeutic goods regulationAssists users with navigating the ‘regulatory maze’The service offers:

guidance articles––––– 🔗🔗

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interactive decision tools educational face-to-face workshops across Australiarecorded presentations on regulatory obligations email and phone supporta subscription service to keep up-to-date with news and events

tga.gov.au/sme-assist [email protected] 1800 020 653

The TGA website (and SME Assist portal) contains useful information about the regulation of therapeutic goods and contact details for different areas of TGA


https://www.tga.gov.au/sme-assist

More information

TGA website – tga.gov.au

Facebook – TGA Australia

Twitter – @TGAgovau

YouTube – TGA Australia

🔗🔗

TGA topics blog - tga.gov.au/blogs/tga-topics

SME Assisttga.gov.au/sme-assist

[email protected] 1800 020 653

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Q&A

Brian ChamberlainMedical Devices

(Pre-market)

Leanne McCauleyAdvertising

Chris HarwoodMedical Devices

(Post-market)

Dr Gaelene PykeOTC medicines

Dr Pradip AdhikariOTC medicines

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