Updated 4 May 2022

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Updated by Rosalind Hewett, Rebecca Storen and Emma Vines
Original version by Alex Grove
Social Policy

Introduction

Therapeutic goods are health-related products. They are used in humans for various reasons including managing illnesses or injuries, altering bodily processes, preventing or testing for pregnancy or replacing or modifying parts of the body. Therapeutic goods include medicines prescribed by a doctor or dentist, medicines available over-the-counter in pharmacies and other retail outlets, complementary medicines (such as vitamins, herbal and traditional medicines), medical devices (such as bandages, COVID-19 rapid antigen tests and pacemakers), vaccines and other goods such as blood products and disinfectants. Foods and cosmetics are generally not therapeutic goods. In Australia, therapeutic goods are regulated by the Therapeutic Goods Administration (TGA).

This quick guide provides an overview of how therapeutic goods are approved, how their supply is regulated, and how they are monitored for safety in Australia. It focuses on areas likely to be of interest to the Australian Parliament and is not intended to be a comprehensive account of the TGA functions.

Therapeutic Goods Administration (TGA)

The TGA regulates therapeutic goods to ensure they are of high quality, safe to use and work as intended. The TGA administers the Therapeutic Goods Act 1989 (the Act) which sets out requirements and obligations for the supply, import, export, manufacture and advertising of therapeutic goods.

The TGA is part of the Australian Government Department of Health. It is largely self-funded and operates on a cost recovery basis. The TGA charges fees for services (such as evaluating a new product) and annual charges on industry (for example, a charge to the sponsor for listing a product on the Australian Register of Therapeutic Goods). All monies received by the TGA are credited to the Therapeutic Goods Administration Account, which is a special account established under section 45 of the Act. These monies are used to fund regulatory activities in Australia and to allow the TGA to participate in international regulatory activities for therapeutic goods.

Approval process for therapeutic goods

A person or organisation wishing to supply a therapeutic good in Australia must apply for market authorisation from the TGA. The TGA assesses the application, and if market authorisation is granted, the therapeutic good is entered on the Australian Register of Therapeutic Goods (ARTG).

In most cases, therapeutic goods must be entered on the ARTG before they can be lawfully imported into, supplied in, or exported from Australia. For cases where patients can access products that have not been approved for use in Australia, see the section below on ‘Access to unapproved goods’.

The ARTG can be searched online. Each entry has a Public Summary document detailing the date the product was included on the ARTG, its intended use and the name of the product’s sponsor (usually a pharmaceutical company or device manufacturer, who must be an Australian resident or be an incorporated body in Australia and conducting business in Australia). Many medicines have further information in the form of a Consumer Medicines Information leaflet (for patients) and a Product Information document (for health professionals).

Medicines may be prescribed to treat a different disease or group of people from what is specified in the ARTG entry. This is a common practice known as ‘off-label’ prescribing.

The TGA takes a risk-based approach to assessing applications for market authorisation. Lower risk products are subject to checking based on certification, whereas higher risk products undergo a more detailed process involving active evaluation of information provided by sponsors.

Application pathways for medicines

Applications to list or register a medicine on the ARTG follow different pathways, depending on the level of risk involved:

• Listed medicines (for example, vitamins and many other complementary medicines) contain only certain low-risk ingredients and only make low-level health claims from a list of permitted indications (reasons for use). The application pathway for listing on the ARTG is based on self-certification by sponsors, with an emphasis on the safety and quality of the product, rather than its efficacy. Most complementary medicines are listed medicines.
• Assessed listed medicines also contain only certain low-risk ingredients, but make intermediate level health claims. The application pathway for listing on the ARTG involves self-certification of quality and safety by sponsors, and evaluation of efficacy evidence by the TGA.
• Registered medicines (including all prescription and most over-the-counter medicines) contain higher-risk ingredients and may make high level health claims. The application pathway involves an assessment by the TGA of the safety, quality and efficacy of the medicine before it can be registered on the ARTG.

Table 1 sets out the key differences between listed, assessed listed and registered medicines.

Table 1     Differences between listed, assessed listed and registered medicines

Attribute	Listed	Assessed listed	Registered
Pre-market efficacy assessment	No	Yes	Yes
Ingredients	From a list of pre-approved ingredients only	From a list of pre-approved ingredients only	Ingredients are assessed pre-market
Indications (conditions the medicine says it will treat)	From a list of pre-approved conditions only	Conditions are assessed pre-market	Conditions are assessed pre-market
Subject to post-market compliance reviews	Yes	Yes	No
Subject to post-market surveillance (e.g. adverse event monitoring)	Yes	Yes	Yes
Available off-the-shelf	Yes	Yes	Some
Needs a prescription	No	No	Some
Can use ‘TGA-assessed’ claim	No	Yes	Yes, for registered complementary medicines

Source: Therapeutic Goods Administration, How we regulate medicines, 20 June 2019.

Legislated timeframes for TGA decisions on whether to approve new medicines vary, depending on the pathway. As part of the approval process for registered medicines, scientific and clinical experts evaluate the detailed dossier of data and evidence (from clinical trials and other sources) submitted by the sponsor. The TGA can also seek advice from the expert Advisory Committee on Medicines. A senior TGA regulator considers all this information and decides whether the benefits of the medicine outweigh the risks, and therefore whether it should be registered for supply.

Prescription medicine registration

A prescription medicine is a medicine that can only be made available to a patient on the written instruction of an authorised health professional. The TGA uses 3 pathways to assess a prescription medicine: the standard pathway, the priority review pathway and the provisional approval pathway. The TGA is required by statute to complete its evaluation for approval of a medicine in the standard pathway within 255 working days, but in practice it works to a target timeframe of 220 working days from acceptance of the application for evaluation through to the delegate’s decision. More urgent applications can be prioritised.

Priority review and provisional approval allow fast-tracking of prescription medicines onto the market. The priority review pathway has a target timeframe of 150 working days and allows for faster assessment of vital and life-saving prescription medicines. Sponsors of promising new prescription medicines (with only preliminary clinical data available) can seek fast-tracked registration through the provisional approval pathway.

The TGA allows sponsors submitting via the provisional approval pathway to put in rolling submissions of additional information, such as clinical data while the TGA is evaluating their application, where this information may have a material impact on the registration decision. Sponsors can apply for full registration when sufficient clinical data to confirm safety and efficacy become available. The provisional approval pathway can be used, for example, to prioritise treatments and vaccines for COVID-19 (see below).

All pathways require evidence that medicines are made according to Good Manufacturing Practice (GMP). GMP describes principles and procedures to ensure therapeutic goods are of high quality. The TGA inspects Australian (and some overseas) manufacturers to ensure compliance with GMP standards.

The TGA publishes statistics on its performance each year, including how many applications it has processed by medicine type.

Fast-tracked approval of COVID-19 vaccines and treatments

As of early 2022, COVID-19 vaccines are considered through the provisional approval (or provisional registration) pathway process, through which they are granted temporary registration where the potential benefits of the vaccine are considered to outweigh the potential risks.

For a COVID-19 vaccine to be considered for provisional registration, the sponsor must first apply for, and receive, a provisional determination by the TGA, which is effective for 6 months (with the option of a 6 month extension). A provisional determination means that the TGA has accepted the sponsor’s request to proceed with fast-tracking the sponsor’s application for provisional approval. Timeframes for decisions on provisional approval of COVID-19 vaccines have varied, from several weeks to several months. This process is outlined in further detail in the Parliamentary Library’s COVID-19 vaccines quick guide.

A similar approach for COVID-19 treatments has been adopted, where the TGA must issue a provisional determination before a sponsor can apply through the provisional registration process for the provisional approval of the COVID-19 treatment.

Information on approval decisions

The TGA publishes its reasons for approving or not approving prescription medicine applications in Australian Public Assessment Reports for prescription medicines (AusPARs). AusPARs can be searched by brand name, active ingredient or sponsor on the TGA website.

The TGA does not assess medicines for cost effectiveness, and the inclusion of a medicine on the ARTG does not mean that its cost will be subsidised by the Australian Government. A medicine sponsor seeking to have their medicine subsidised must follow a separate application process to have the medicine listed on the Pharmaceutical Benefits Scheme (PBS). This process is described in further detail in the Parliamentary Library’s quick guide to the Pharmaceutical Benefits Scheme.

Scheduling

Medicines are classified into Schedules which determine how freely they will be available to the public. For example:

• Unscheduled products (such as aspirin and paracetamol) are available for general sale from stores such as supermarkets.
• Schedule 2 (S2) medicines (such as diarrhoea medicines and antihistamines) are available on the shelf at pharmacies.
• Schedule 3 (S3) medicines (such as some asthma inhalers) are kept behind the counter at pharmacies and can be purchased following consultation with a pharmacist. They do not require a prescription.
• Schedule 4 (S4) medicines (such as antibiotics and nicotine vaping products) must be prescribed by an authorised healthcare professional.
• Schedule 8 (S8) medicines are controlled drugs (such as very strong pain relievers) with strict requirements for prescribing and supply.

The Schedules are published in the Poisons Standard and are given effect through state and territory legislation.

The Secretary of the Department of Health (in practice, their delegate) makes decisions on the scheduling of medicines (and chemicals), and other changes to the Poisons Standard. The Secretary may make a medicine scheduling decision on their own initiative, as part of the registration process for a new medicine (described above) or following an application from a sponsor or other interested party to reschedule a medicine (to make it easier or harder to access) (pp. 9–11).

When deciding on a schedule for a medicine, the Secretary or their delegate may seek advice from the Advisory Committee on Medicines Scheduling. Interim and final scheduling decisions, and the reasons for these decisions, are published on the TGA website.

Application pathways for medical devices

Medical devices are used in humans to treat illness or modify or monitor functions of the body. They generally achieve this through physical, mechanical or chemical means. They are classified according to risk, ranging from lowest risk (Class I) for items such as bandages, to highest risk (Class III and Active Implantable Medical Devices) for items such as heart valves and pacemakers.

Regulatory requirements for medical devices in Australia are considered among the most stringent in the world (p. 3). In recent years, the TGA has been reviewing and updating its medical device regulatory framework, including implementing a priority review pathway for medical devices to fast-track approvals. To have a medical device included in the ARTG, the manufacturer must:

• demonstrate that the device meets the Essential Principles set out in Part 1, Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002, which detail the design and manufacturing requirements for medical devices to ensure they are safe and perform as intended
• undertake conformity assessment, which is the systematic and ongoing examination of evidence and procedures to ensure that a device conforms to the Essential Principles. Some low risk devices only require manufacturer self-assessment of conformity, while higher risk devices require a conformity assessment certification issued by the TGA or a notified body comparable overseas regulator or assessment body.

The degree of scrutiny the TGA applies to applications depends on the level of risk associated with the device. Some low-risk devices can be ‘auto-included’ in the ARTG upon application (with supporting evidence held by the sponsor), some devices can be included in the ARTG based on the information provided in the application (outlined above), and some higher risk applications will be audited by the TGA.

Similar to medicines, manufacturers and sponsors can seek a priority review for medical devices for either a TGA conformity assessment certificate or for inclusion in the ARTG. Applicants must meet 3 criteria for priority applicant determination, including that the purpose of the device is to monitor, treat, prevent or diagnosis a life-threatening or seriously debilitating condition.

Access to unapproved goods

Therapeutic goods generally need to be entered on the ARTG before they can be sold in Australia. However, there are a number of ways that patients can gain access to products that have not been approved for use in Australia.

• The Special Access Scheme (SAS) allows a health practitioner to access an unapproved therapeutic good for an individual patient on a case-by-case basis.
  • SAS category A is for patients who are terminally ill or facing premature death without treatment. A prescribing medical practitioner or health practitioner on behalf of a prescribing medical practitioner must notify the TGA within 28 days of a medicine being given or after the use of an exempt medical device.
  • SAS category B is the general pathway followed when neither category A nor category C applies. The health practitioner must apply to the TGA for approval before the unapproved product can be accessed and supplied to the patient.
  • SAS category C allows certain types of health practitioners to supply specified therapeutic goods with an established history of use for a particular condition. Health practitioners must notify the TGA that they are prescribing an unapproved therapeutic good within 28 days of the therapeutic good being supplied.
• Medical professionals can apply to the TGA to become an ‘Authorised Prescriber’ of a specific unapproved good to specific patients with a particular medical condition. In some instances, doctors also need to have their application approved by a human research ethics committee or endorsed by a specialist college.
• Depending on the level of risk involved, a sponsor of a clinical trial can make either a notification or application to the TGA to use an unapproved good in the trial.
• Under the Personal Importation Scheme, individuals can legally import a three-month supply of some unapproved therapeutic goods for personal use, without TGA approval. A prescription from an Australian-registered medical practitioner is required for S4 and S8 medicines.
• If a medicine included in the ARTG is in short supply, the Secretary (or delegate) can approve the import and supply of a substitute medicine that is not on the ARTG. In some instances, pharmacists are allowed to substitute medicines, including different strengths or forms of a product, without a prescribing doctor’s approval where a medicine is unavailable.

Monitoring of goods on the market

The TGA also monitors therapeutic goods once they have been approved and are on the market. This is known as post-market monitoring. Depending on the type of good and the degree of risk, post-market monitoring activities may include risk management plans, collecting reports of adverse events and reactions, reviewing worldwide complaints data for medical devices, auditing manufacturers, and scanning medical literature and media reports to identify safety issues.

Adverse events are unintended and sometimes harmful events (including side effects) associated with the use of a therapeutic good. The TGA records reports of adverse events in two searchable Databases of Adverse Event Notifications: one for medicines and vaccines and one for medical devices. An adverse event report does not necessarily mean that the therapeutic good caused the event, nor that it is unsafe. Rather, the TGA uses these reports to identify when a safety issue may be present. Reporting of adverse events by consumers and health professionals is voluntary, but sponsors and manufacturers must report serious adverse events to the TGA. Following strong public interest in adverse event reports relating to COVID-19 vaccinations and improvements to its IT systems, the TGA announced in August 2021 that it was reducing the time between adverse events being accepted into its database and being published from 90 days to 14 days.

The TGA has several ways to let health professionals and the public know of safety concerns for medicines on the market. These include:

• monitoring communications to highlight potential concerns about a therapeutic good
• alerts where a safety concern has been investigated and advice needs to be given
• recalls when a therapeutic good needs to be modified or removed from the market
• updating the Medicines Safety Update publication for health professionals.

The TGA can also restrict access to a product or remove it from the ARTG altogether.

Sponsors of registered S4 (Prescription Medicine), S8 (Controlled Drug) and some over-the-counter medicines must notify the TGA if the medicine is not likely to meet the normal or projected consumer demand within Australia during the next 6 months or is being discontinued.

 

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