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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 part of the body. Therapeutic goods include
medicines (complementary, over-the-counter and prescription), medical devices
(such as bandages and pacemakers) and other goods such as blood products and
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 as a comprehensive account of the TGA’s
Therapeutic Goods Administration
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
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 imposes annual
charges on industry. 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
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).
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’.
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). Many medicines have further information in the
form of a Consumer
Medicines Information (CMI) leaflet (for patients) and a Product Information (PI)
document (for health professionals).
Medicines may be prescribed to treat a different disease
or group of people than is specified in the ARTG entry. This is known as 'off-label'
prescribing, and it is a common practice.
The TGA takes a risk-based approach to
assessing applications for market authorisation. Lower risk products
receive a lesser degree of checking based on certification, whereas higher risk
products undergo a more detailed process involving active evaluation of information
provided by sponsors.
The application pathways for medicines and medical devices
are briefly outlined below.
Application pathways for medicines
Applications to include a medicine on the ARTG follow different
pathways, depending on the level of risk involved:
medicines (such as vitamins and 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
is based on self-certification by sponsors, with an emphasis on the safety and
quality of the product, rather than its efficacy (effectiveness).
listed medicines also contain only certain
low-risk ingredients, but make intermediate level health claims. The application
pathway involves self-certification of quality and safety by sponsors, but
evaluation of efficacy evidence by the TGA.
medicines (including all prescription 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. The TGA generally has 255
working days to complete an evaluation
of a new prescription medicine. 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
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 in Australia.
of new vital and lifesaving prescription medicines can seek permission to
follow a priority
review pathway, which allows for faster assessment of applications (around
150 working days).
of promising new prescription medicines (with only preliminary clinical data
available) can seek time-limited registration through the provisional
approval pathway. Sponsors can apply for full registration when sufficient
clinical data to confirm safety and efficacy become available.
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.
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 a subsidy must
follow a separate application process to have the medicine listed on the Pharmaceutical Benefits Scheme (PBS).
This process is outlined in the Library’s quick
guide to the PBS.
are classified into Schedules which determine how freely they will be
available to the public. For
- 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 cholesterol
medicines) must be prescribed by an authorised healthcare professional and
- 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 legal effect through state
and territory legislation.
The Secretary of the Department of Health (or 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).
When deciding on a schedule for a medicine, the Secretary or
delegate may seek advice from the Advisory
Committee on Medicines Scheduling. Interim
scheduling decisions, and the reasons for these decisions, are published on the
Application pathways for 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.
In order to have a medical device
included in the ARTG, the manufacturer must:
- demonstrate that the device meets the Essential Principles set out in Schedule 1 of the Therapeutic Goods
(Medical Devices) Regulations 2002. The Essential Principles detail the
design and manufacturing requirements for medical devices to ensure they are
safe and perform as intended and
- 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 will require a conformity assessment certification issued
by the TGA or a European
notified body (an organisation designated by a European Union country to
assess the conformity of certain products before they are placed on the
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.
Manufacturers or sponsors seeking to speed up
the process for either TGA conformity assessment or inclusion of the device on
the ARTG can apply for Priority
Review. To be eligible, they must demonstrate that the
device offers a major improvement over existing treatments for a serious
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.
Access Scheme (SAS) allows a health practitioner to access an unapproved
therapeutic good for an individual patient on a case-by-case basis.
category A is for patients who are terminally ill or facing premature death
without treatment. The prescribing doctor notifies the TGA that they are
prescribing an unapproved therapeutic good to the patient.
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.
category C applies to designated medicines, medical devices
(human cell or tissue-based products, or live animal products) with an
established history of use for a particular condition. Health practitioners
must notify the TGA that they are prescribing an unapproved therapeutic good
from one of these lists.
Doctors can apply to the TGA to become an ‘Authorised Prescriber’
of a specific unapproved good to specific patients with a particular medical
condition. Such 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
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 doctor’s
prescription 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.
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 involved,
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.
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(DAEN): 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 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.
The TGA has a number of ways of letting the health
professionals and the public know of safety concerns for medicines on the
market. These include:
communications to highlight potential concerns about a therapeutic good
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 and
- the Medicines
Safety Update publication for health professionals.
The TGA can also restrict
access to a product, or remove it from the ARTG altogether.
Therapeutic goods reforms
In October 2014 the Australian Government announced an independent
review to investigate how therapeutic goods regulation could be streamlined and
enhanced, without undermining quality or safety. The Expert
Panel Review of Medicines and Medical Devices Regulation provided two
reports to the Government in 2015, recommending
extensive legislative and administrative changes to the system. The
49 of the 58 recommendations (in full or in principle) and made provision
for the reforms in the 2016–17 Budget.
The two tranches of reform legislation were introduced into
the Australian Parliament in December
2016 and September
2017, and subsequently passed. Many of the reforms have now been
implemented (including the priority review and provisional approval pathways
for medicines and changes to the SAS scheme), but others are still in
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