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Evidence guidelines

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

1 February 2019

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Note that the evidence requirements for listed medicines have not changed in the January 2019 V 3.0 version. The Evidence guidelines will be subject to a broader review in 2019 to improve the clarity and useability of the document for sponsors.

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Background

The Therapeutic Goods Act 1989 (the Act) 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 help sponsors understand their regulatory obligations in relation to holding that evidence.

In January 2019 the guidelines were reviewed to incorporate changes to the regulatory framework for listed medicines arising from amendments to the Act, effective 6 March 2018. The amendments to the Act introduced:

  • A list of permitted indications from which AUSTL listed medicines must exclusively draw.
  • An additional listing pathway [AUSTL(A) assessed listed], which provides an option for listed medicines to make higher level indications, when the efficacy of the medicine has been assessed by the TGA. For more information refer to Assessed listed medicines evidence guidelines.

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

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