2. Why do we need regulation?
2
Australian doctor William McBride alerted
the world to the dangers of thalidomide
in the 1960s which triggered the need for
an Australian regulator of therapeutic
goods.
“In recent months I have
observed that the incidence of
multiple severe abnormalities
in babies delivered of women
who were given the drug
thalidomide (‘Distival’) during
pregnancy, as an anti-emetic
or as a sedative, to be almost
20%.”
3. Who is Australia’s regulator?
3
• The Therapeutic Goods Administration was
established in 1990 to “safeguard and enhance
the health of the Australian community through
effective and timely regulation of therapeutic
goods”
• It provides a national system of controls
relating to the quality, safety, efficacy and
timely availability of therapeutic goods used
in, or exported from, Australia
Health
Safety
Regulation
4. TGA - ORGANISATION
4
• TGA is part of the Australian Government
Department of Health
• Every decision the TGA makes is based on the
Therapeutic Goods Act 1989
• Main offices in Canberra – satellite offices in
Sydney, Melbourne, Adelaide and Brisbane
5. Who works at the TGA?
5
Approximately 750 staff made up of:
Biomedical
scientists
Engineers Physiotherapists Medical officers
Pharmacists Nurses Toxicologists Lawyers
Nutritionists Dieticians Scientists
Administrative
staff
6. TGA STRUCTURE
The TGA Regulatory offices are grouped into :
1. Market Authorization Group
2. Monitoring and Compliance Group
3. Regulatory Support Group
TGA Executive: The TGA Executive has overall responsibility for the
management of the TGA's regulatory activities.
7. The TGA Executive:-
—TGA National Manager
—Principal Medical Adviser
—Principal Legal Adviser
—Chief Regulatory Officer
—Chief Operating Officer
8. Market Authorization Group
Undertake evaluations of applications to approve new therapeutic
products for supply in Australia.
The MAG makes decisions whether to approve or reject market
authorization of medicines, medical devices and blood and tissues that
are imported, exported, manufactured and supplied in Australia.
9. The Monitoring and Compliance Group
is responsible for ongoing monitoring of therapeutic products
approved for supply in Australia to ensure they meet the necessary
standards throughout their lifecycle.
10. Regulatory Support Group
Provides whole-of-agency regulatory support services to the TGA, this
includes the legal, finance, information technology and information
management, communications, parliamentary and human resource
management services.
11. The TGA is supported in its work by a number of external expert advisory
committees, including
Australian Drug Evaluation Committee (ADEC) - for prescription
medicines
Adverse Drug Reactions Advisory Committee (ADRAC)
Medicines Evaluation Committee(MEC) - for over-the-counter medicines
Complementary Medicines Evaluation Committee(CMEC) - for
complementary medicines
Therapeutic Devices Evaluation Committee (TDEC) - for medical
devices
National Drugs and Poisons Scheduling Committee (NDPSC)
Therapeutic Goods Committee (TGC)
12. TGA’s mission
12
To safeguard and enhance the health of the Australian
community through the effective and timely regulation of
therapeutic goods.
Health
Safety
Regulation
13. How TGA fulfil this mission?
13
1
2
3
Good Manufacturing Practice or Manufacturing Principles: licensing Australian
manufacturers and verifying compliance of overseas manufacturers (see the TGA
education module on GMP)
Premarket assessments: assessing therapeutic goods for quality and safety (the extent
of the assessment depends on the type of product and level of associated risk), and
for higher risk products also for efficacy or performance
Postmarket assessments: monitoring of therapeutic goods and enforcement of standards
(see the TGA education module on postmarket monitoring)
14. Role of the TGA
The TGA carries out an overall control through five main processes:
Pre-market evaluation and approval of registered products intended for
supply in Australia;
Development, maintenance and monitoring of the systems for listing of
medicines;
Licensing of manufacturers in accordance with international standards of
GMPs
Post-market monitoring, through sampling, adverse event reporting,
surveillance activities, and response to public inquiries;
The assessment of medicines for export.
15. Australian register of therapeutic goods (ARTG)
The Australian Register of Therapeutic Goods (ARTG) was established under the Therapeutic
Goods Act 1989. The ARTG is a computer database of therapeutic goods. Therapeutic goods are
divided broadly into two classes: medicines and medical devices. Unless exempt, medicines must
be entered as either 'registered' or 'listed' medicines and medical devices must be included before
they may be supplied in or exported from Australia
16. Under the Therapeutic Goods Act 1989, therapeutic
goods are defined as:
16
Products for use in humans in connection with
• preventing, diagnosing, curing or alleviating
a disease, ailment, defect or injury
• influencing, inhibiting or modifying a
physiological process
• testing the susceptibility of people to a
disease or ailment
• influencing, controlling or preventing
conception
• testing for pregnancy
• replacing or modifying parts of the anatomy
All these
products are
therapeutic
goods!
17. The benefit versus risk approach
17
• No therapeutic good is risk free
• The work of the TGA is based on
applying scientific and clinical
expertise to decision making
• Ensure that the benefits outweigh any
risks associated with the use of
medicines, medical devices and other
therapeutic goods
18. Types of therapeutic goods
18
Medicines and blood products
• prescription medicines
• over-the-counter medicines
• complementary medicines
• blood, blood components and plasma derivatives
Medical devices
• implants (artificial hips, breast implants)
• in-vitro diagnostics (pregnancy tests, blood glucose monitors)
• low risk medical devices (bandages, tongue depressors, condoms)
Biologicals
• human stem cells
• tissue-based products (skin and bone)
• cell-based products
19. Australian Register of Therapeutic Goods
All goods must be entered in the ARTG before they can be supplied in, imported to,
or exported from Australia
• higher risk medicines that are
registered on the ARTG
• evaluated for quality, safety
and efficacy
• Product Information is
approved by the TGA
• All prescription medicines
• Most over-the-counter medicines
• Some complementary medicines
• lower risk medicines that are
listed on the ARTG
• contain pre-approved, low risk
ingredients
• can only make limited claims
and cannot imply that they will
be useful in the treatment or
prevention of serious illnesses
• Some over-the-counter medicines
• Most complementary medicines
• higher risk devices are
evaluated for quality, safety
and performance
• lower risk devices are not
evaluated for performance
Devices are classified according
to their level of risk, ranging from
Class I (lower risk) such as urine
collection bottles to Class III
(higher risk) such as antibiotic
bone cements
Registered medicines Listed medicines Medical devices
19
20. Registered medicines
• Registered medicines have an 'AUST R' number on the label and/or
packaging
There is a large amount of information to consider
It takes approximately 11 months to evaluate one new higher risk
prescription medicine
Evaluation is undertaken by scientists and clinicians who look at data on:
• Quality
• Safety and efficacy
22. Once approved for marketing in Australia, medicines are included in the ARTG
and can be identified by the AUST R number (for registered medicines) or
an AUST L number (listed medicines) that appears on the packaging of the
medicines.
Medicines that are assessed to be higher risk are individually evaluated for
quality, safety and efficacy.
Higher risk products approved by the TGA are included on the ARTG as
registered medicines.
Listed medicines are low risk medicines and are included on the ARTG via low-
cost and streamlined electronic application and validation process
23. Whether a product is listed or registered in the ARTG depends
largely on three things:
—The ingredients
—The dosage form of
the product
—The promotional or
therapeutic claims
made for the product.
24. In assessing the level of 'risk', factors such as
—strength of a
product
—side effects,
—toxicity, and
—the seriousness
of the medical
condition for
which the product
is intended to be
used.
25. Product Information (PI)
Product Information (PI) is a term used to describe the technical information
approved by the TGA and intended for distribution to health professionals
Statement of ingredients
Directions for use and dosage
Warning statements and contraindications
Distinctiveness of labels
Graphics, logos and symbols
Reference to other products
Internet addresses
Foreign language text on labels.
26. The PI should contain information under the
following headings
Name of the medicine
—Description
—Pharmacology
—Clinical trials
—Contraindications
—Precautions
—Adverse effects
—Dosage and administration
—Overdosage
—Storage conditions
—Name and address of the sponsor
—Date of approval
27. . Listed medicines
Listed medicines are considered to be of lower risk than registered
medicines. The majority of listed medicines are self-selected by
consumers and used for self-treatment, such as vitamin and mineral
products or sunscreens.
They do NOT contain substances that are scheduled in the
SUSDP(Standard for the uniform Scheduling of Drugs and Poisons)
Most complementary medicines (eg. herbal, vitamin and mineral
products) and sunscreens are examples of listed products.
All listed medicines must display an "AUST L" number on the label as
proof of listing.
28. Registered medicines
Medicines assessed as having a higher level of risk must be registered.
The degree of assessment and regulation they undergo is rigorous and
detailed, with sponsors being required to provide comprehensive
safety, quality and efficacy data.
All registered medicines must display an AUST R number on the label as
proof of registration;
They are evaluated as either 'high risk' or 'low risk' registered if they are
prescription medicine or non- prescription medicine respectively.
29. Prescription medicines Non-prescription medicines
• High-risk Registered products.
• This group includes all
prescription medicines and some
specified products such as
sterile injectables.
• lower risk than prescription
medicines
Examples of products in this
category are mild analgesics,
cough/cold preparations, anti-fungal
creams.
30. Complementary medicines
TGA has developed the Australian Regulatory Guidelines for
Complementary Medicines (ARGCM) to assist sponsors of
complementary medicines to meet their legislative requirement.
Complementary medicines are also known as 'alternative medicines',
'natural medicines' ‘traditional medicines’
Examples include vitamins, minerals, nutritional supplements and
herbal, aromatherapy and homeopathic products.
31. Purpose of ARGCM
• Provide information to help sponsors of complementary medicines to
meet their therapeutic goods legislation;
• Applications to the TGA relating to complementary medicines
processed successfully within minimum time frames;
• Enhance clarity and transparency of processes leading to the
Registration and Listing of complementary medicines in the Australian
Register of Therapeutic Goods (ARTG).
32. Over-The-Counter
• These are medicines which are available without a prescription but not
‘complementary medicines’.
• The object of the guidelines is to assist sponsors to submit
applications which will be evaluated in the minimum possible time and
be successful.
33. Where an evaluation of a product or substance via the OTC route, the
primary factors to be taken into account include:
The safety of the active substance;
The need for professional counseling before use;
The nature of the ailments or symptoms to be treated
The abuse potential of the product or substance;
The incidence of adverse effects and contraindications;
The risk of masking serious disease;
The risk/benefit profile of the product (eg. therapeutic index).
34. The Act states that the presentation of OTC medicine is unacceptable
If it is capable of being misleading or confusing as to the content or
proper use of the goods.
if it suggests that the goods have ingredients, components or
characteristics that they do not have.
If a name applied to the goods is the same as the name applied to other
therapeutic goods that are supplied in Australia
If the label of the goods does not declare the presence of a
therapeutically active ingredient
35. Medical devices
Medical Devices Evaluation Committee (MDEC) provides advice to the Minister
on issues relating to the safety, quality, performance and timely availability
of medical devices
The regulation of medical devices includes the following features:
• classifying the medical device based on different levels of risk
• assessing compliance with a set of essential principles for their quality,
safety and performance
• implementing appropriate regulatory controls for the manufacturing
processes of medical devices
• including the medical device in the ARTG
• Implementing a comprehensive post market vigilance and adverse incident
reporting program
36. Examples of medical devices include
blood pressure monitors
breast implants
Catheters
lubricating eye drops
MRI scanners
Syringes
tongue depressors
37. Key elements of the medical device regulatory scheme is to ensure quality, safety
and performance of the medical device that must be complied:
• Before the device is supplied to the market in Australia, OR
• on an ongoing basis while the device is supplied to the market in Australia
• monitoring of medical devices that are available on the market
• regulatory controls for the manufacturing processes of medical devices THE
AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (ARTG) AS THE CENTRAL
POINT OF CONTROL FOR THE LEGAL SUPPLY OF MEDICAL DEVICES IN
AUSTRALIA
• Provision for imposing penalties where regulatory requirements are breached
• Range of corrective actions should be taken if there is a problem with a device.
38. Blood and tissues
It include
Blood,
Blood components
Plasma derivatives
Tissue and cellular products
Tissue cell based derivatives
It is Regulated under the Therapeutic Goods Act 1989.
39. Chemicals
The Office of Chemical Safety undertakes the risk assessment and provides
advice on potential public health risks posed by chemicals used in
community.
Example includes : Cosmetics, Agricultural, Veterinary, Industrial Chemicals,
Pesticides, Environmental chemical, Cosmetic use chemicals.
40. . Excluded:-. However, it is important to note that all other applicable
requirements under the Act and Regulations (eg. standards and
advertising or labelling) must be complied with.
41. Exempt or excluded medicines
• Excluded medicines are products (mostly therapeutic devices, rather
than medicines) may be unintentionally covered by the definition of a
Therapeutic Good. They are therefore specifically excluded under
section 7 of the Act.
• An example of an excluded good is unmedicated soap.
• Exempt medicines do not need to be registered or listed in the ARTG
as a result of a specific exemption or determination.
All medicines manufactured for supply in Australia must be listed or registered in
the Australian Register of Therapeutic Goods (ARTG) unless they are exempt or
excluded
