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Evidence guidelines

Guidelines on the evidence required to support indications for listed complementary medicines

24 July 2014

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Background

The Therapeutic Goods Act 1989 requires that, at the time of listing a medicine in the Australian Register of Therapeutic Goods (ARTG), sponsors must certify that they hold evidence to support any indications and claims made about their medicine.

The Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines specify the type of evidence required to support indications made for listed medicines (excluding sunscreens and disinfectants) and help sponsors understand their regulatory obligations in relation to holding that evidence.

These guidelines replace the TGA's previous publication: 'Guidelines for levels and kinds of evidence to support indications and claims'.

Once listed in the ARTG, a proportion of listed complementary medicines are reviewed for compliance with relevant regulatory requirements. Any listed complementary medicine may be selected for compliance review at any time after it is listed in the ARTG. For further information see Listed complementary medicine compliance reviews.

Evidence package checklists are available on the TGA website to help sponsors assess, record and present the available evidence for the indication/s for their medicine. Appendix 1 of the Evidence guidelines provides guidance on using these checklists. If a medicine is selected for a review of the evidence that the sponsor holds to support the indication/s for the medicine, it is recommended that the required information be presented in the format provided in the Evidence package checklists.

For further information on the regulation of complementary medicines in Australia, please refer to the The Australian regulatory guidelines for complementary medicines (ARGCM).

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