Updated by Rosalind Hewett, Rebecca Storen and Emma
Vines
Original version by Alex Grove
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:
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:
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.