Basics of therapeutic goods regulation

9 June 2017

Contents

Introduction

It's important that Australians have access to quality therapeutic goods that are safe to use and fulfil their intended purpose. The Therapeutic Goods Administration (TGA), as part of the Department of Health, protects the health and wellbeing of the community by regulating and monitoring all therapeutic goods that are distributed here in Australia.

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, in addition to any other relevant Commonwealth, state and/or territory legislation. Civil and criminal penalties may apply if you do not meet your legal requirements.

This material is an overview of therapeutic goods regulation in Australia, and should be used as a guide only. If you'd like more information about any of the topics, please refer to the additional links or the TGA website.

If you're looking to import, supply, export or manufacture a therapeutic good:
"It is easy to understand what is required, but what is required of you isn't necessarily easy."

Is my product a therapeutic good?

9 June 2017

Therapeutic goods are products for therapeutic use; that is, they are intended to be used for human health.

For a full definition of therapeutic goods, go to Section 3 of the Therapeutic Goods Act 1989.

Therapeutic use means use in or in connection with:

  • preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or
  • influencing, inhibiting or modifying a physiological process in persons; or
  • testing the susceptibility of persons to a disease or ailment; or
  • influencing, controlling or preventing conception in persons; or
  • testing for pregnancy in persons; or
  • the replacement or modification of parts of the anatomy in persons.

If your product meets the above definition and criteria, you are required to engage with the TGA.

Therapeutic goods fall under three different categories:

  • Medicines (including prescription, over-the-counter and complementary medicines, such as paracetamol and echinacea)
  • Biologicals (something made from or containing human cells or tissues, such as human stem cells or skin)
  • Medical devices (including instruments, apparatuses and appliances, such as pacemakers and sterile bandages)

Therapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol. The TGA also regulates what are known as Other Therapeutic Goods (OTGs), which include items such as tampons and disinfectants.

A tool has been prepared to help you identify if your product may be a therapeutic good.

The role of the TGA

9 June 2017

The TGA regulates and monitors therapeutic goods through various processes.

  • We authorise the commercial supply of therapeutic goods for use in Australia through the Australian Register of Therapeutic Goods (ARTG), an electronic register of therapeutic goods that can be lawfully supplied in Australia.
  • We monitor the safety of therapeutic goods using information from various sources, including the community, healthcare providers, overseas regulators and the ARTG entry holders ('sponsors') and manufacturers as a part of their reporting obligations.
  • We authorise Australian manufacturers to ensure products made in Australia are of an appropriate standard.

The TGA is required to recover its costs through fees and charges for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities. For more information about the TGA see:

How are therapeutic goods regulated?

The approach to regulation for therapeutic goods depends on the level of risk to public health and/or safety of the product. For example, therapeutic goods that pose a higher risk of adverse events or are used for more serious diseases (such as prescription medicines) are more tightly regulated and monitored than those that pose a lower risk (such as herbal supplements).

When a product is in a higher risk category, we:

  • regulate it more carefully using more rigorous assessment processes
  • require more data or information, especially to demonstrate quality, safety, efficacy and performance
  • have higher fees for manufacturers and sponsors, especially where the therapeutic good might require more monitoring or needs more scrutiny

If a product meets all regulation requirements, it can be added to the ARTG. However, there are special circumstances where therapeutic goods not on the ARTG can be lawfully supplied (such as for clinical trials). This information is relevant to researchers who are developing new innovative therapeutic products. For more information: Accessing unapproved products.

Once you have determined what type of therapeutic good you have, you will need to determine the risk level. For more information:

What are some key terms I need to understand?

9 June 2017

If you have not previously been involved in regulation of therapeutic goods, here are some key terms that might be useful to know.

The ARTG is an electronic register of therapeutic goods that can be lawfully supplied in Australia, and provides information such as the product name, active ingredients (in the case of products such as medicines), classification (in the case of medical devices), sponsor and manufacturer.

More about the ARTG

Every ARTG entry belongs to a sponsor, and they are responsible for applying for and maintaining the ARTG entry. If someone else has an ARTG entry for a particular therapeutic good, that does not make it legal for you to import or supply that therapeutic good, even if the manufacturer is the same.

To supply a therapeutic good, you need to have:

  • your own ARTG entry for that therapeutic good, or
  • a retail arrangement with a sponsor who has an ARTG entry for that therapeutic good

To import or export a therapeutic good, you need to have your own ARTG entry.

There are special circumstances where therapeutic goods not on the ARTG can be lawfully supplied. For more information: Accessing unapproved products

Additionally, there are certain products not on the ARTG that are not considered unapproved, such as custom-made medical devices and homeopathic remedies.

For more information about the ARTG: Searching the ARTG

Conformity assessment is the way by which a manufacturer demonstrates a device (and the process to manufacture it) meets safety, quality and performance requirements. For more information:

GMP describes a set of principles and procedures that seek to ensure the manufacture of medicines and biologicals are consistent and of high quality.

More about GMP

GMP is based on the principle 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

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

Indication (registered medicines, listed medicines, Class 3 & 4 biologicals), intended use (Class 2 biologicals), and intended purpose (medical devices) are words used to describe the specific therapeutic use of a product.

If you are producing the therapeutic goods, or are involved in any part of producing the therapeutic goods, you are involved in manufacture

There are subtle differences between these definitions as they apply to manufacturing of medicines and biologicals, and manufacturing of medical devices.

More about manufacture

Manufacture does not just consist of making tablets or putting a medical device together. Many of the steps leading up to these steps are part of manufacturing, as are the packaging and labelling steps.

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

  • 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 Therapeutic Goods Act 1989.

Australian manufacturers of medicines and biologicals need to obtain a TGA licence. For more information: Guidance on licensing/certification inspections.

All medical devices seeking inclusion in the ARTG (except for Class I non-sterile or non-measuring devices) require conformity assessment certification to support their ARTG application. That certification may be obtained from TGA or from a European notified body with the appropriate authority.

Once your product is being supplied, you have ongoing responsibilities and legal obligations. You need to advise us of any issues relating to your product to ensure that it continues to meet regulatory requirements.

The TGA also has a key role to play. We receive and manage adverse event reports from health professionals and the community, and work with overseas regulators.

A sponsor is the person or organisation who exports, imports or manufactures a therapeutic good (for supply in Australia or elsewhere), or arranges for another party to do any of these things. They have to be a resident of Australia, part of a company in Australia, or conducting business in Australia.

The person or organisation who applies for registration, listing or inclusion of a product on the ARTG becomes the sponsor once the product is approved, and their product must be entered on the ARTG before it can be sold in Australia.

A full definition of a sponsor can be found in Chapter 1, Section 3 of the Therapeutic Goods Act 1989.

Under special circumstances where the therapeutic good is not included on the ARTG, you may still be considered the sponsor and the good can still be lawfully supplied (such as for clinical trials). For more information: Accessing unapproved products

All sponsors of therapeutic goods, whether the good is on the ARTG or not, have a number of responsibilities. As a sponsor, you need to be able to:

  • obtain information from the manufacturer when requested by the TGA
  • comply with requirements for records of distribution and supply
  • notify the TGA of adverse events or problems with the goods you sponsor
  • notify the TGA of an issue that needs to be corrected, such as a recall
  • undertake regulatory actions relevant to the products supplied, where necessary
  • comply with the requirements for advertising therapeutic goods
  • ensure all fees and charges issued to your organisation by the TGA are paid

Note: The list above does not describe every sponsor obligation. See our training session on sponsor obligations.

Australian manufacturers often also sponsor their own products; they can apply directly to the TGA to enter their products on the ARTG. If a product is manufactured overseas, however, the application for entry on the ARTG needs to be made by an eligible sponsor.

It is essential the sponsor has a formal relationship with the overseas manufacturer because they will undertake a range of responsibilities on the manufacturer’s behalf, such as:

  • applying for GMP clearance for medicines and some biologicals that are regulated overseas in the same way they are in Australia, and have therefore already been inspected by an acceptable regulator via desktop assessment. For more information: GMP clearance for overseas manufacturers
  • organising for the TGA to inspect the overseas manufacturer if GMP certification is necessary - for example, for some complementary medicines, sunscreens and biologicals or where there is no evidence for a GMP Clearance via the desktop assessment pathways. For more information: Guidance on licensing/certification inspections
  • undertaking post-market responsibilities such as adverse event reporting.

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 the product through administration or applying treatment.

More about supply

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

  • 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

Applying for an ARTG entry

9 June 2017

Before applying for an ARTG you need to set up as a sponsor. For more information: TGA Business services: getting started with the TGA
To apply for an ARTG entry, follow the guidance for your type of therapeutic good:

For more information: /industry-educational-materials

Cost

9 June 2017

The amount that regulation will cost you depends on:

  • whether you are a manufacturer, a sponsor, or both
  • the type of therapeutic good
  • the risk classification of the therapeutic good
  • the amount of data you will have to collect and provide (which can be considerable)

Be aware that there will likely be business setup costs to ensure your product can meet the regulatory requirements before you apply to the TGA, and ensure ongoing compliance with the regulatory requirements.

The TGA has both fees and charges: Summary of fees and charges

  • A fee is charged for a service, such as a product evaluation
  • A charge is a form of tax imposed on the regulated industry and is applied annually based on a 1 July to 30 June financial year

Failing to pay your required annual charge may result in your product being removed from the ARTG.

Other regulators

9 June 2017

Depending on the product, a therapeutic good can be subject to additional legislation. For more information: see “Other local Australian regulators” under Useful Resources.