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Additionally, it will also describe potential impact of the changes on complementary medicines industry and consumers.
1.2 Purpose
The purpose of this research is to describe the impact of the TGA reforms on complementary medicines to the industry and consumers
2. Literature Review
2.1 Therapeutic Goods Administration TGA
The Therapeutic Goods Administration TGA is an Australian government institution under the Department of Health and Ageing that has the responsibility to
regulate therapeutic goods supplied in Australia including the evaluation of its quality, safety and efficacy. These therapeutic goods comprise prescription
medicines, over-the-counter medicines, medical devices and complementary medicines. The scope of its regulatory control would include the supply,
manufacturing and advertising of therapeutic goods TGA, 2014. During a product life cycle the TGA is responsible for the pre-market assessment,
post-market monitoring and licensing of its Australian manufacturers. In spite of how the therapeutic goods are approved for sale, either as Aust L or Aust R, it is
subjected to post market monitoring once it has listed or registered on the Australian Register of Therapeutic Goods ARTG TGA, 2014.
TGA post market regulatory activity of complementary medicines consists of the following elements TGA, 2014; NICM, 2014:
inspection of manufacturers for compliance with Good Manufacturing Practice
GMP
compliance review for listed complementary medicines
monitoring if adverse reactions to complementary medicines
AJOR
ESEARCH
ROJECT
S
WINBURNE
U
NIVERSITY OF
T
ECHNOLOGY
Lina Karlina 2067226
Page 10 of 25
laboratory testing of complementary medicines in forms of products and
ingredients
surveillance in the market place
control and monitoring of complementary medicines advertising
2.2 Complementary Medicines
According to the Therapeutic Goods Regulations 1990, a complementary medicine is defined as a therapeutic good consisting principally of one or more designated
active ingredients mentioned in Schedule 14 of the Regulations, each of which has a clearly established identity and traditional use TGA, 2014
In Australia, complementary medicines would include vitamins, minerals, herbals, nutritional supplements, certain aromatherapy preparations and homoeopathic
products. In relation to regulatory framework, complementary medicines are classified into two types based on its potential risks to consumers, these are TGA,
2014:
Low-risk complementary medicines, can be listed on the ARTG
High-risk complementary medicines, must be registered on the ARTG Complementary medicines are regulated under the Australian Regulatory Guidelines
for Complementary Medicines ARGCM. It contains regulatory requirements that complementary medicines sponsors are bound to comply with.
The risk profiles of complementary medicines are established based on the
following elements TGA, 2014:
The composition of substances in the product
The potential in resulting adverse effects either from short-term or long-term
use or due to inappropriate administration.
The use of complementary medicine in treatment of serious disease.
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WINBURNE
U
NIVERSITY OF
T
ECHNOLOGY
Lina Karlina 2067226
Page 11 of 25
Product risk is inherent in therapeutic goods including complementary medicines. However, the risks are acceptable when the benefits outweigh the risks. Risks that
may be occurring in respect to the use of complementary medicines are as follows Harvey, 2008; NICM, 2014:
Adverse reaction
Drug interaction when consumed together with some conventional medicines
Use a complementary medicine to replace clinically proven treatment
Sponsors are not allowed to make indications and claims for listed complementary medicines other than for health maintenance, health improvement and treatment of
non-serious illness. There are certain information that the labels of complementary medicines required to
have which include NICM, 2014:
Product name
Name and quantities of ingredients
Name of ingredients that are known to present a risk to some consumers
Dosage form
Quantity of the medicine
Required warning statements
Directions for use
Name and address of the sponsor
Indicationsclaims
Registrationlisting number
3. Methodology
