Lina Karlina (2067226) Page 1 of 25
CHE8000 Major Research Project A
The Complementary Medicines Reforms and Its Impact to the
Complementary Medicine Industry and the Consumer
Lina Karlina (2067226) Page 2 of 25 TABLE OF CONTENTS
Abstract ... 6
1 Introduction ... 6
1.1 Background ... 6
1.2 Purpose ... 9
2 Literature Review ... 9
2.1 Therapeutic Goods Administration (TGA) ... 9
2.2 Complementary Medicines ... 10
3 Methodology ... 11
4 Discussion ... 12
4.1 Complementary Medicines Reforms ... 12
4.1.1 Update to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM)... 14
4.1.2 Update to the key regulatory guidance document on the evidence a sponsor should hold in support of indications for listed medicines ... 14
4.1.3 Update to the listed medicines electronic application portal ... 15
4.1.4 Enhancing post-market monitoring ... 15
4.1.5 Publishing outcomes of listing compliance reviews ... 15
4.1.6 Permitted (coded) indications project ... 16
4.1.7 Investigation process for advertising breaches ... 16
4.2 Impact of Complementary Medicine Reforms to the Industry and the Consumer ... 18
5 Conclusion and Recommendation ... 23
5.1 Conclusion ... 23
5.2 Recommendation ... 24
List of Tables ... 3
Lina Karlina (2067226) Page 3 of 25 References ... 24
Lina Karlina (2067226) Page 4 of 25 List of Tables
Lina Karlina (2067226) Page 5 of 25 List of Pictures
Lina Karlina (2067226) Page 6 of 25 The Complementary Medicines Reforms and Its Impact to the Complementary Medicine
Industry and the Consumer
Abstract
It is identified that complementary medicine industry in Australia is continuously growing.
This is due to the increasing use of complementary medicines which may be cause by the
assumption that complementary medicines are risk-free, safer and only contains natural
ingredients as well as the search for alternative or a substitute of conventional medicines.
According to the result of post-market compliance review conducted by the Therapeutic
Goods Administration (TGA) in 2010 and the performance audit conducted by the Australian
National Audit Organisation (ANAO) in 2011 a high number of complementary medicine
non-compliance were identified. To address the recommendations given in the Auditor-General’s report and the results of informal working group review the Secretary of Department of Health and Ageing (DoHA) published ‘TGA Reforms: A Blueprint for TGA’s Future’ which one of its reforms is associated with complementary medicines. The complementary medicine reforms consist of seven aspects and are aimed to reduce the level
of non-compliance by sponsors. These changes to complementary medicines regulatory
framework are most likely to have impact on the industry and the consumer which include
better understand of the current Australian guidelines on complementary medicines, sponsors
are encouraged to continuously comply with the regulatory requirements, more informed
consumer in regards to complementary medicines and the increased protection of consumer
from misleading indications.
1. Introduction 1.1Background
There are 10000 complementary medicines supplied in Australian market and only
about 200 of them are registered on the Australian Register of Therapeutic Goods
(ARTG). The remaining numbers of complementary medicines are listed on the
ARTG. This proportion of registered and listed complementary medicines (98%:2%)
Lina Karlina (2067226) Page 7 of 25 which normally slow, high cost and demands more and strict requirements e.g.
clinical trial documents.
According to the National institute of Complementary Medicine (NICM), at least two
out of three Australians use Complementary Medicine (CM) and in the period of
2010-2011 Australians spent more expenses on CM ($2 billion) compare to
conventional medicine e.g. prescribed medicines, over the counter medicines ($1.6
billion) (NICM, 2014).
A survey conducted in November 2013 to January 2014 shows that the Australian
complementary industry is healthy and growing with significant growth estimation in
2017-2018 ($4.6 billion revenue, increase to 45,000 employees). The increasing use
of complementary medicines in Australia is probably due to several factors as follows
(NICM, 2014):
The search for substitute of conventional medicines with less adverse effects.
Many consumers view complementary medicines as natural and considered as risk-free (no adverse effects) or at least safer compare to conventional medicines.
However, there is no risk-free therapeutic product including complementary
medicine even it is listed on the ARTG that considered low–risk complementary
medicines.
There are potential risks pose by prolonged use of some conventional medicines
Relatively lower cost than conventional medicines especially prescribed medicines
The increased number of chronic disease, elderly
Complementary medicines supplied in Australian market are regulated by the TGA
and must be either listed or registered on the Australian Registration of Therapeutic
Lina Karlina (2067226) Page 8 of 25 risk medicines can be listed on the ARTG. The listing can be conducted by pre-market
self-assessment scheme through the Electronic Listing Facility (ELF). Therefore, the
products are not evaluated by the TGA for its safety, quality and efficacy before
entering the market. However, the ELF system ensures that the products only contain
permitted (safe) substances for low risk products and are manufactured in GMP
licensed facility (Harvey, 2008). The self-assessment method is highly depends on
trust on the complementary sponsor. Nevertheless, the scope of post-market
monitoring by the TGA covers all medicines regardless its registration scheme (listed
or registered).
Complementary medicines started to draw attention to its stakeholders including
regulatory authority, industry and consumers due to two major incidences. The first
incidence occurred in 2003 when the Pan Pharmaceuticals recalled more than 1600 of
its complementary medicine products. The second incidence occurred in 2010 when
the Department of Health and Ageing (DoHA) released a result of post-market
compliance review conducted by TGA on complementary medicines. It is reported
that 90% of the reviewed complementary medicines were non-compliant with
regulatory requirements which partially required removal from the ARTG and only 3
products were compliant (DoHA, 2011).
Given the two major incidences, an audit was conducted in August 2011 by the
Australian National Audit Organisation (ANAO) as part of periodic audit on TGA’s
performance was focused on listed complementary medicines. As a response, in December 2011 the DoHA published several reforms compiled in the ‘TGA Reforms: A Blueprint for TGA’s Future’ which one of its reforms is related to complementary medicines. The purpose of these reforms on complementary medicines is to reduce the
level of non-compliance by sponsors. In this reforms project the TGA holds a major
role in planning, implementing, monitoring and evaluating the results.
This research is intended to describe the changes in complementary medicines
Lina Karlina (2067226) Page 9 of 25 Additionally, it will also describe potential impact of the changes on complementary
medicines industry and consumers.
1.2Purpose
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
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.
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 Indications/claims
Registration/listing number
3. Methodology
Method that will be used in this research is qualitative research method to analyse
Lina Karlina (2067226) Page 12 of 25 4. Discussion
4.1Complementary Medicines Reforms
Reforms in regards to complementary medicines are part of the “TGA reforms: A blueprint for TGA’s future” which was raised by The Secretary of Department of Health and Ageing (DoHA) in December 2011. The ‘TGA reforms: A blueprint for TGA’s future’ was published as a response to several major reviews in therapeutic goods regulations carried out by government institutions and informal working groups
in 2010 and 2011. Among those reviews there were two reviews that are directly
related to complementary medicines. The first review is the Auditor-General’s report
on Therapeutic Goods Regulation: Complementary Medicines that was released on 30
August 2011 as a result of performance audit conducted by the Australian National
Audit Office (ANAO) in the same year. The second review is when an informal
working group was examining the complementary medicines regulation and causes of
low percentage of regulatory compliance.
The diagram below shows a simple process map that describes how the
Lina Karlina (2067226) Page 13 of 25 Picture 1. Process map of complementary medicines reforms
8 December 2011: TGA Reforms: A Blueprint for TGA’s future
These reforms are grouped under the following themes:
Communications and stakeholder engagement
Advertising of therapeutic products
Complementary medicines (Complementary Medicine Reforms)
Medical devices
Promotion of therapeutic products
Major reviews of therapeutic goods regulations in 2010 & 2011:
The review to improve the transparency of the TGA
Public consultations on the regulatory framework for advertising therapeutic goods
The Auditor-General’s report on Therapeutic Goods Regulation: Complementary Medicines (August 2011)
An informal working group examining the regulation of
complementary medicines and reasons for low compliance rates
Public consultations on the medical devices regulatory framework
The Working Group on Promotion of Therapeutic Products
The Health Technology Assessment Review
The Auditor-General’s report on Therapeutic Goods Regulation:
(Addresses the above 2 reviews in respect to complementary medicines: Auditor-General’s report and Informal Working Group)
Update to the Australian Regulatory Guidelines for Complementary Medicines
Update to the key regulatory guidance document on the evidence a sponsor should hold in support of indications for listed medicines
Update to the listed medicines electronic application portal
Enhancing post-market monitoring
Publishing outcomes of listing compliance reviews
Permitted (coded) indications project
Lina Karlina (2067226) Page 14 of 25 As mentioned in the above diagram the Complementary Medicines Reforms include
seven aspects that will be described in the following discussion (TGA, 2014).
4.1.1 Update to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM)
This reform is a response to the Auditor-General’s report particularly on one of
its findings which is that the TGA has taken and continues to take a long time in
reviewing guidance documentation for complementary medicines (ANAO,
2011). This situation may cause precariousness on how to comply with the
regulatory requirements. Moreover, currency is an important nature of
regulatory guidance which will affect the regulator on how to respond on
findings.
Therefore, the Australian Regulatory Guidelines for Complementary Medicines
(ARGCM) as one of the primary guidelines that regulate complementary
medicines is updated by the TGA in a timely manner through the following
activities (DoHA, 2011):
Publish completion date for the update of ARGCM
Provide periodic reports of progress on the current updates include its publication on the TGA website.
4.1.2 Update to the key regulatory guidance document on the evidence a sponsor should hold in support of indications for listed medicines
One of the recommendations from Informal Working Group review is to update the ‘Guidelines for levels and kinds of evidence to support indications and claims’ which was published on April 2011. In order to address the
recommendation the TGA has replaced it with the ‘Evidence guidelines:
Guidelines on the evidence required to support indications for listed
complementary medicines’ which was published on March 2014 and refined on
July 2014. The revision of previous guidelines was conducted through public
Lina Karlina (2067226) Page 15 of 25 that the guidelines stay current and applicable with present situation (DoHA,
2011).
4.1.3 Update to the listed medicines electronic application portal
In the Auditor-General’s report it was recommended that the TGA enhance the
integrity of listing procedure of complementary medicines due to the increased
number of inappropriate use of free-text field on the electronic system by
sponsors. This reform on the electronic application portal is aimed to ensure that
only permitted claims or indications are made by the sponsors for their
complementary medicines. To achieve this purpose the TGA has planned to
remove the free-text field from the electronic application portal. By doing so the
TGA has directed the sponsors to use only the permitted list of indications
available on the portal (DoHA, 2011).
4.1.4 Enhancing post-market monitoring
Based on the performance audit conducted by the ANAO in 2011 apparently the
TGA did not utilise the results of compliance review on listed complementary
medicines for further use. Therefore, the TGA was recommended to use the
results of compliance review in generating risk profiles on sponsors and
complementary medicines which later will provide a tool in determining priority
of targeted post-market reviews (ANAO, 2011). This reform in post-market
monitoring program is carried out to improve the compliance rate with the
existing regulatory framework of complementary medicines. The TGA has
agreed to the recommendation made by the ANAO by implementing a
risk-based approach in the conduct of its post-market reviews (DoHA, 2011).
4.1.5 Publishing outcomes of listing compliance reviews
According to the ANAO findings the TGA has not publicise the results of its
Lina Karlina (2067226) Page 16 of 25 for a long time and that those results are considered important information for
consumers in selecting complementary medicines to be used. Nevertheless, the
TGA has always announced review outcomes which may result in adverse
reaction and/or product recall (ANAO, 2011).
In order to provide information associated with listing compliance review to
consumers the TGA will make the information available to public through the
provision of publicly-viewable elements on the ARTG. This information will
include the complementary medicines that have been reviewed as part of the
post-market monitoring program as well as the review outcomes (DoHA, 2011).
4.1.6 Permitted (coded) indications project
The trigger for this reform associated with permitted indications project is the
increased rate of inappropriate claims made about listed complementary
medicines by the sponsors. This reform is closely related to the previous reform which is ‘Update to the listed medicines electronic application portal’ (section 4.1.3) since it has the same reason and purpose for the reforms to be taken
(ANAO, 2011).
Accordingly, the TGA will improve the permitted indications for listed
complementary medicines through addition of new indications obtained from
the evaluation of claims frequently made by sponsors in the free-text field on
the ARTG (DoHA, 2011).
4.1.7 Investigation process for advertising breaches
Great number of breaches in complementary medicine advertising such as
prohibited terms use and unpermitted claims are currently exist in many media
including a widely used media, internet. The TGA holds a major responsibility
in managing advertising breaches compared to other national agencies
associated with advertising e.g., the Therapeutics Goods Advertising Code
Council (TGACC) and the Complaints Resolution Panel (CRP). It was
Lina Karlina (2067226) Page 17 of 25 of advertising violations which resulted in two recommendations (ANAO,
2011).
To address the finding and recommendations the TGA have planned a number
of measures in order to improve the investigation process for advertising
violations which include (DoHA, 2011):
Implementation of standard operating procedure for investigating
advertising breaches
Development of timeframes to complete investigations of advertising breaches
Periodic reporting of the investigation progress to the TGA Executive
It is planned to take four years for the Blueprint reforms to be completely
implemented. This four years implementation period is divided into 3 phases as
follows (TGA, 2012):
Phase 1 (January – June 2012): better managing our communication Phase 2 (July 2012 – June 2013): better managing our practice
Phase 3 (July 2013 – December 2015): mature and sustainable performance Based on the Blueprint Implementation Schedule the implementation of
complementary medicine reforms is scheduled to finish in phase 2 with the following
details:
Table 1. Implementation schedule of complementary medicines reforms
Lina Karlina (2067226) Page 18 of 25 4.2Impact of Complementary Medicines Reforms to the Industry and the
Consumers
The impact of complementary medicine reforms on the industry and its consumers
will be discussed according to each reform as described below.
4.2.1 Update to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM)
To the industry:
It is more likely to increase the compliance rate of complementary industry to
the regulatory requirements since the updated guidelines represent the current
regulatory framework. The probability of increase of compliance rate is also
supported by the consultation process held after the first updated version of this
guideline was published involving the TGA and the complementary medicine
stakeholders to maintain the pertinence and currency of information available in
the guidelines (DoHA, 2011).
To the consumer:
The higher the industry compliance rate to regulatory requirements the higher
assurance that their products are safe and of good quality. Provided with the
assurance that complementary medicines available in market place are safe and
of good quality, it will result in higher consumer confidence in using
complementary medicines which later may cause the increase of complementary
medicines usage.
4.2.2 Update to the key regulatory guidance document on the evidence a sponsor should hold in support of indications for listed medicines
To the industry:
The evidence guidelines describe the types and levels of evidence required to
Lina Karlina (2067226) Page 19 of 25 including complementary medicines. By revising the previous guidelines to
ensure the currency of information contained the sponsors will be more
well-informed on the requirements demanded by the regulator and eventually it will
likely increase the compliance rate to the regulatory requirements particularly
when the TGA conducts its listing compliance review.
In spite of the positive impact, this reform on the evidence guidelines renders
difficult some of the small industry of complementary medicines since it
normally lack of resources to perform pre-clinical or clinical trial (CMA, 2014).
To the consumer:
Claims or indications made about complementary medicines provided with
scientifically sound evidence will increase the trust of consumers on the safety,
quality and efficacy of complementary medicines because it is scientifically
proven rather than just traditionally known to be effective for certain symptoms.
4.2.3 Update to the listed medicines electronic application portal
To the industry:
This reform is performed by eliminating the free-text field on the application
portal which will direct the sponsors to use only the available indications
provided by the TGA. These indications have been assessed and permitted to be
used for low risk medicines such as listed complementary medicines. Therefore, it will limit the sponsors’ freedom in making claims and indications for their products which this can be considered as an advantage when the sponsor
deliberately misuses the free-text field to make misleading or unsubstantiated
claims or indications for promotion purposes. Moreover, it will be difficult for
the sponsors to make particular indications that are not available in the list but
considered as appropriate for low risk products. Given the situation, the sponsor
Lina Karlina (2067226) Page 20 of 25 procedure would not be simple since it has to pass through assessment and
regulation amendments (DoHA, 2011).
To the consumer:
Consumer will be more protected from misleading and unsubstantiated claims
and indications. This is crucial especially when the sponsors do not hold
evidence to support the safety of their products.
4.2.4 Enhancing post-market monitoring
To the industry:
Since a risk-based approach will be implemented on the TGA’s post-market
monitoring program through the utilisation of risk profiles of sponsors and
products characteristics which means products that pose high probability of
non-compliant and sponsors who frequently innon-compliant will be more often
subjected to post-market monitoring (Harvey, 2012). Therefore, this reform
encourages the industry to continuously comply with regulatory requirements.
To the consumer:
This will provide greater assurance to consumer that the listed complementary
medicines reviewed by the TGA are proven to be safe, manufactured in GMP
licensed facility, of good quality and effective. On the other hand, consumer
may become unsure in regards to the safety, quality and efficacy of listed
complementary medicines that have not been reviewed since post-market
monitoring is performed only on a small percentage of the medicines.
4.2.5 Publishing outcomes of listing compliance reviews
To the industry:
Providing the results of listing compliance reviews to public through the TGA
Lina Karlina (2067226) Page 21 of 25 may be considered as free promotion media by notifying the public that their
products have been reviewed and passed all the regulatory requirements.
Nevertheless, it results in different situation when the products did not pass the
review. Moreover, the company’s reputation may be damaged when the
companies were given sanctions or financial penalties by the TGA and the
medicine reviewed or other medicines produced by the company may be in
questioned by consumer in regards to its safety, quality and efficacy. Consumer
may question the safety, quality and efficacy of the product reviewed even if the
product was only incompliant with some aspects of the regulatory requirements.
To the consumer:
Publication of the outcomes of listing compliance reviews on the TGA website
provides easy access for consumer to obtain information on complementary
medicines that have been reviewed as well as the outcomes which will greatly
assist the consumer in making well-informed decision associated with
complementary medicines use.
4.2.6 Permitted (coded) indications project
This measure will be taken to support the previous action planned by the TGA
which is the update to the listed medicines electronic application portal.
Therefore, the impact are more likely to be similar.
To the industry:
The sponsors are only allowed to use indications permitted in the list which
have been assessed by the TGA. This project limits the sponsors that previously
used the free-text field to deliberately make misleading claims and indications
for commercial purposes (Harvey, 2012).
To the consumer:
The indications available on the label of complementary medicines packaging
Lina Karlina (2067226) Page 22 of 25 Accordingly, it will prevent the consumers from being exposed to misleading
and inappropriate indications.
4.2.7 Investigation process for advertising breaches
To the industry:
A risk-based approach will also be implemented in the investigation of
advertising violations where risk profiles will be developed and trends will be
made based on previous or historical data of advertising breaches (DoHA,
2011). Through trending of the breaches it will be easier to identify sponsors
that often conducted violation on advertising as well as the common type of
advertising breaches. In this regard, sponsors required to better understand and
will be more aware of regulations and requirements applied to advertising of
complementary medicines.
The development of investigation timeframes by the TGA will affect the
response time to address complaint associated with violation in advertising as
well as the time required to determine follow-up action (e.g. sanctions, financial
penalties) to the sponsor who conducted the breaches.
To the consumer:
The completion of investigation associated with advertising breaches within
specified timeframes ensures that follow up action in regard to the
advertisement (e.g. withdrawal from media or public spaces) will be promptly
carried out. It is necessary to have a fast response to prevent the more
widespread of misleading information contained in the advertisement to a larger
Lina Karlina (2067226) Page 23 of 25 5. Conclusion and Recommendation
5.1Conclusion
The complementary medicine reforms consist of the following elements:
- Update to the Australian Regulatory Guidelines for Complementary
Medicines
- Update to the key regulatory guidance document on the evidence a sponsor
should hold in support of indications for listed medicines
- Update to the listed medicines electronic application portal
- Enhancing post-market monitoring
- Publishing outcomes of listing compliance reviews
- Permitted (coded) indications project
- Investigation processes for advertising breaches The impact of the reforms to the industry would include:
- The sponsors became better understand the Australian guidelines for
complementary medicines (e.g. ARGCM, Evidence guideline) as well as the
approach to comply with current regulatory framework.
- The sponsors are more encouraged to continuously comply with the
regulatory requirements.
- The sponsors are limited to use only the permitted indications during listing
of complementary medicines through the Electronic Listing Facility (ELF). The impact of the reforms to the consumer would include:
- The consumer became more informed on complementary medicines that
have been reviewed for compliance
- The increased consumer’s assurance that the complementary medicines
supplied in the market place are safe and of good quality.
- The increased protection of consumer from misleading, inappropriate or
Lina Karlina (2067226) Page 24 of 25 5.2Recommendation
It is recommended that the government:
Provides more incentives to encourage the industry to comply with the regulatory framework of complementary medicines.
Accommodates the industry to conduct clinical research in complementary medicines to encourage evidence-based complementary medicines
Provides basic information especially associated with listed complementary medicines in an interesting way to educate consumer as well as to assist in
informed decision making.
Applies more enhanced sanctions and financial penalties to advertising breaches.
References
ANAO, 2011, The Auditor – General audit Report No. 3 2011 – 12 Performance Audit Therapeutic Goods Regulation: Complementary Medicine, Australia.
CMA, 2014, 2014 Complementary Medicines Industry Survey, Australia
DoHA, 2011, TGA Reforms: A Blueprint for TGA’s Future, Australia.
Harvey, K, 2008, Does CM regulation need reform?, Australia.
Harvey, K, 2012, TGA Complementary Medicines Reforms, Australia.
NICM, 2014, The Safety of Complementary Medicines, Australia.
NICM, 2014, Information for Consumers: Reports, Surveys and Audits, Australia. <http://www.nicm.edu.au/health_information/information_for_consumers/reports,_
surveys,_audits>
TGA, 2012, Delivering Reforms – Implementation Plan for TGA Reforms: A Blueprint for TGA’s Future, Australia.
Lina Karlina (2067226) Page 25 of 25 <http://www.tga.gov.au/complementary-medicine-regulation-basics>
TGA, 2014, Complementary Medicines Reforms, Australia.
< http://www.tga.gov.au/complementary-medicines-reforms>
TGA, 2014, TGA Basics, Australia. <http://www.tga.gov.au/tga-basics>
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