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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)
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
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
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.
Tags: OTC, medicines, australia, guidance
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