Evidence guidelines

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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).

Version history

Version Description of change Author Effective date
V1.0 Original publication Therapeutic Goods Administration, Office of Complementary Medicines October 2001
V1.1 Change of format Therapeutic Goods Administration, Office of Complementary Medicines April 2011
V2.0 Revision Therapeutic Goods Administration, Office of Complementary Medicines March 2014
V2.1 Table 6, correction of BMI range to state 25-30kg/m2 Therapeutic Goods Administration, Office of Complementary Medicines July 2014

Copyright

© Commonwealth of Australia 2014
This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted under the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>.

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