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Regulatory Focus™ > News Articles > Australia Revises OTC Evidence Guidance

Australia Revises OTC Evidence Guidance

Posted 28 August 2012

Australia's Therapeutic Goods Administration (TGA) has released revised guidance on the evidence required to support indications made for over-the-counter (OTC) medicines.

The revised version now permits two ways to provide supporting evidence to the TGA: established sources, such as comprehensive evidence reviews conducted by international regulators (Sources of Established Evidence or "SEE"), or full systematic reviews conducted by the product sponsor where established sources do not exist (Evidence Report).

The new guidance includes essential steps required during the consideration of a SEE, and during the development and fulfillment of the requirements of an Evidence Report. This includes guidance about literature searching, and the assessment of the level, relevance, quality, outcomes and overall balance of currently available evidence.

In recognition of evidence used to support indications for listed medicines is often obtained from the available literature rather than sponsor-initiated clinical trials specifically conducted with a proposed product, a large portion of the guidance is dedicated to providing direction on the assessment of the relevance of scientific and evidence of traditional use to a proposed indication.

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