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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 can request for the new indications to be added to the list. However, the
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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 incompliant 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
