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Regulation essentials

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If you're a small to medium enterprise (SME), start-up, researcher or simply new to therapeutic goods regulation, here you'll find a general overview of the regulatory processes you need to be aware of.

There are many resources available on our website to assist you and there is no rule about how early you can engage with the TGA.

If you're new to therapeutic goods regulation we recommend you view this page in the order it appears. If you're more confident with regulation, scroll down to the area you are unsure of and discover what resources are available to you.

If you're looking to import, supply, export or manufacture a therapeutic good, you will need to meet certain requirements and obligations in accordance with the Therapeutic Goods Act 1989 (the Act), in addition to any other relevant Commonwealth, state and/or territory legislation.

Understanding your obligations as a sponsor of a therapeutic good and ensuring you are compliant with all applicable legislation is your responsibility.

Failure to meet your obligations may subject you to civil and criminal penalties.

About TGA and regulation

The TGA regulates therapeutic goods in Australia.

It is important to have an understanding of the role of the TGA and regulation of therapeutic goods, so you understand what your responsibilities are.

The following information will introduce you to some basic concepts and get you started:

We only regulate therapeutic goods

The TGA only regulates therapeutic goods. You need to know if you have a therapeutic good so you can comply with relevant legislation. If you don't have a therapeutic good, you might not need to engage with the TGA at all.

You can use our interactive decision tools to help you determine if you have a therapeutic good and if so, what type:

Note that the TGA cannot make this determination for you.

Our website also has information to help you determine which regulatory scheme may apply to your product:

We do not regulate:

  • veterinary medicines
  • food
  • health insurance
  • cosmetics
  • chemicals
  • healthcare professionals
  • clinical practice

If you would like more information on how these products are regulated, you will need to contact the relevant agency responsible for their regulation. You can find more information at What the TGA doesn't do.

Supplying therapeutic goods in Australia

Unless exempt or excluded, all products presented as therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before being imported into, supplied in or exported from Australia. This includes software and mobile 'apps' that meet the definition of a medical device, see Regulation of software as a device for more information.

If a person is receiving a therapeutic good from you through sale, gift, lease, loan, hire or hire-purchase, you are a supplier of that therapeutic good. This includes if it is free of charge (such as a sample or through product testing), or even if you're supplying a product through administration or applying treatment.

Supply is described in Section 3 of Therapeutic Goods Act 1989 (the Act) as:

  • supply by way of sale, exchange, gift, lease, loan, hire or hire-purchase
  • supply, whether free of charge or otherwise, by way of sample or advertisement
  • supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in persons
  • supply by way of administration to, or application in the treatment of, a person

We have the following resources on our website that can provide more detail and help you understand the supply process:

Being a sponsor

If you or your company either are, or intend to:

  • export therapeutic goods from Australia
  • import therapeutic goods into Australia
  • manufacture therapeutic goods for supply within Australia or elsewhere
  • arrange for the import, export or manufacture of therapeutic goods

then you may be a sponsor of therapeutic goods.

In order for a product to be included in the ARTG, a sponsor must submit an application to the TGA, together with relevant supporting data. The sponsor of a therapeutic good included in the ARTG must be an Australian resident and/or carrying on business in Australia.

As the sponsor, you are the one who:

  • obtains the ARTG entry
  • carries all associated responsibilities
  • is financially and legally liable for the good

If you are importing a therapeutic good from overseas with the intention to supply in Australia, you are the one who needs to apply for the ARTG entry prior to importing the good, and you are the one with the responsibilities that belong to a sponsor.

Resources

The TGA offers a range of resources to help you navigate your journey with us. Keep in mind that engaging with the TGA is only one part of your journey towards supplying a therapeutic good in Australia. Our Useful resources for business provide more information about:

  • funding opportunities and support
  • conducting research
  • independent regulatory advice
  • other useful information

Before your therapeutic good is included in the ARTG

Before applying for market authorisation, you need to understand your pre-market responsibilities such as:

  • fees and charges
  • manufacturing
  • advertising
  • market authorisation application

These will change depending on the type and/or classification of your therapeutic good.

For example, a listed medicine will have different market authorisation requirements than a prescription medicine.

Regulation and classification of therapeutic goods

Now you know you have a therapeutic good, you need to know what type and classification you have as this will impact what responsibilities you have with TGA.

There are four main categories of therapeutic goods:

  • Medicines
  • Biologicals
  • Medicals devices
  • Other therapeutic goods

Within these categories, TGA has different classifications of therapeutic goods regulated according to their level of risk.

See Product regulation according to risk for more information.

For medicines:

  • How we regulate medicines shows how medicines are classified as registered, assessed listed or listed and how this relates to whether you have a prescription or complementary medicine.
  • Is my product a therapeutic good? (interactive decision tool) will also help you determine the type of medicine you have.

For medical devices and in vitro diagnostics (IVDs):

Biologicals and Other Therapeutic Goods (OTG):

Manufacturing your therapeutic good

If you are producing a therapeutic good, or are involved in any part of production of the therapeutic good, you are involved in manufacture.

Manufacture does not just consist of making tablets or putting a medical device together.

Many parts of the process leading up to these steps are part of manufacturing, as are the packaging and labelling steps.

There are differences between the manufacturing requirements that apply to medicines, biologicals and medical devices.

Manufacture of goods that are not medical devices are described in Section 3 of the Therapeutic Goods Act 1989 (the Act) as:

  • producing the goods, or
  • engaging in any part of the process of producing the goods or bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process.

A manufacturer of medical devices is described in Section 41BG of the Act:

  • the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person's name, whether or not it is the person, or another person acting on the person's behalf, who carries out those operations

Note that this is not the entire definition of a manufacturer of a medical device. For more information, go to Section 41BG of the Act.

If you're new to manufacturing, watch our presentation on Manufacturing from our SME Assist 'Meeting Your Obligations' workshop.

For more information on manufacturing in general:

Medicines, Biologicals and Good Manufacturing Practice

Good Manufacturing Practice (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

Medicines and biologicals (except class 1 biologicals), must be manufactured in accordance with the principles of GMP.

For biological and non-biological prescription medicines, the manufacturer of the active pharmaceutical ingredient (API) must also be licensed, or have a clearance.

There are different codes of GMP depending on the type of therapeutic good and whether or not it originates from human blood or tissue.

More detailed information on GMP:

Medical devices do not have GMP specifically, but have equivalent requirements such as following essential principles and obtaining conformity assessment.

Manufacturing licence

If you manufacture, or intend to manufacture, a medicine, biological or other therapeutic good within Australia you must have a current licence to manufacture therapeutic goods.

Australian manufacturers of medicines and biologicals need to obtain a manufacturing licence issued by the TGA for the specific manufacturing steps and dosage forms relevant to the therapeutic good being manufactured, or process occurring at a specific site.

GMP certification and GMP clearance

If you manufacture medicines, biologicals or other therapeutic goods overseas, a sponsor must have appropriate good manufacturing practice (GMP) certification or clearance.

For manufacturing sites located overseas, the sponsor must obtain GMP certification or GMP clearance for the specific dosage forms and manufacturing steps undertaken at that site.

For overseas manufacturers of APIs for over-the-counter and complementary medicines, no GMP clearance is required, although the sponsor is expected to hold evidence of the site's compliance to GMP.

More about manufacturing licences, certification and clearance:

Medical device manufacture and conformity assessment

Conformity assessment is how a manufacturer demonstrates a medical device 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.

For medical devices (except class 1 medical devices), an Australian manufacturer must hold a TGA Conformity Assessment Certificate.

Overseas manufacturers must hold an equivalent certification from a European notified body with the appropriate authority.

For more information:

More about medical device and IVD manufacture and conformity assessment:

Overseas manufacturers

The sponsor should have a formal relationship with their overseas manufacturer because they will undertake various responsibilities on the manufacturer's behalf. These may include (but are not limited to):

Ingredients in therapeutic goods

Ingredients in therapeutic goods are substances used to formulate a medicine. The use of an ingredient in a formulation of a therapeutic good often comes with requirements and restrictions associated with its use.

You can find more information about ingredients at:

Clinical trials

In some circumstances you may need to run clinical trials to gain supporting evidence for the efficacy of your therapeutic good.

The TGA has standards which need to be met and specific clinical trial access schemes available to you.

For more information, see:

Advertising therapeutic goods

TGA regulates how therapeutic goods are advertised.

It's your responsibility you ensure that you comply with the Therapeutic Goods Advertising Code and know whether you can advertise your therapeutic good to consumers (for example, biologicals and prescription medicines are restricted in their advertising).

Anything that would have the effect of inducing a consumer to purchase or use a therapeutic good is likely to be considered advertising, for example:

  • images and graphics may be considered advertising
  • content on your social media page may be considered advertising
  • labels are considered advertising

Watch our Advertising presentation from our SME Assist 'Meeting your Obligations' workshop.

We also have the Advertising hub where you can find advertising requirements, relevant legislation and further assistance with understanding your requirements. This hub also includes the interactive decision tool 'Can I advertise this therapeutic good to the public?'.

Including your therapeutic good in the ARTG

If you wish to supply a therapeutic good within Australia you need to apply to have it included in the ARTG (unless exempt or excluded), this is known as market authorisation. Applications to obtain market authorisation are made through the TGA Business Services portal (TBS).

Pre-submission meeting

In certain circumstances, it may be appropriate that you have a pre-submission meeting with us. For more information, including when we recommend this, see the pre-submission meeting guidance.

Guidance for your therapeutic good application and more

You can find more information about your responsibilities and application requirements in the Australian regulatory guidelines for each type of therapeutic good:

TGA Business Services

TGA Business Services (TBS) is our electronic business services portal.

Before submitting your application, you need to go to TBS and complete the organisation details form in order to obtain a client ID or complete the appropriate service forms to update your organisation details. This will enable you to access our secure online TBS portal.

Submit your completed forms to the TGA TBS Helpdesk at ebs@health.gov.au. For help with completing your forms, see TGA Business services: getting started with the TGA.

Once registered, additional organisation details will need to be completed by the account's Administrator.

You can use TBS to:

  • apply to have a therapeutic good included in the ARTG
  • access information related to your applications and ARTG entries
  • submit clinical trial notifications
  • advise us of adverse events or recalls
  • view and cancel your current ARTG entries and generate certificates
  • review paid and unpaid invoices
  • pay outstanding invoices
  • maintain your contact details

Fees and charges

There are fees and charges associated with your market authorisation application.

The Annual charge exemption scheme (ACE) provides an exemption from paying the annual charge for a good that is registered, listed or included in the ARTG until the ARTG entry first commences generating turnover.

After your therapeutic good is included in the ARTG

Once your therapeutic good is included in the ARTG, you as the sponsor have ongoing legal responsibilities associated with that good. These post-market 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.

Post-market monitoring and surveillance

Ongoing monitoring of therapeutic goods once approved for use in Australia, is an important part of ensuring safety, efficacy and quality of therapeutic goods used in Australia.

Adverse events and serious adverse reactions

Watch our Post-market monitoring presentation for an overview of your ongoing obligations, as reporting some types of adverse events to TGA is mandatory.

You can find out more information:

Medicines shortages, deficiencies or defects

You may also have mandatory reporting obligations for medicines shortages, see Medicines shortages guidance and resources for more details.

You can find information on Report a problem or side effect here.

Recalls

If there is an issue with the safety, quality, efficacy, performance or presentation of a therapeutic good, it may be necessary to recall the good to resolve the issue. You can find more information about recalls on our website.

Getting help

The TGA is unable to provide regulatory advice about individual products, including advice about whether a product is a therapeutic good, what classification of device it may be or assisting with business decisions.

If you require specific advice about your therapeutic good, you should seek the services of a lawyer or regulatory affairs consultant; a list of contact details for industry organisations that may be able to recommend suitable consultants is available on the TGA website.

You can Contact the TGA and specific areas of interest for more detailed information regarding regulatory processes, although we recommend looking at relevant guidance material for your therapeutic good in the first instance.

You can also email sme.assist@tga.gov.au which is a dedicated contact point for SMEs, researchers, start-ups and those new to regulation. We recommend that you subscribe to our SME Assist email list to stay up to date with the latest SME information including upcoming workshops and events.

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