Update to the Australian Regulatory Guidelines for Complementary Update to the key regulatory guidance document on the evidence a sponsor

AJOR ESEARCH ROJECT S WINBURNE U NIVERSITY OF T ECHNOLOGY 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 consultation with the stakeholders to accommodate their opinions and to ensure AJOR ESEARCH ROJECT S WINBURNE U NIVERSITY OF T ECHNOLOGY 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