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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 listing compliance reviews despite the fact that the review has been conducted
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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 andor 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
