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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
consultation with the stakeholders to accommodate their opinions and to ensure
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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