Regulatory Focus™ > News Articles > TGA Calls for Comments on Evidence Needed to Support Low-Risk Claims

TGA Calls for Comments on Evidence Needed to Support Low-Risk Claims

Posted 23 April 2012 | By Alexander Gaffney, RAC 

Australia's Therapeutic Goods Administration (TGA) announced 23 April it is looking for comments on its draft guideline outlining the types of evidence needed to support indications made for low-risk medicines.

TGA's guideline,Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants), is intended to replace an earlier guideline entitled, Guidelines for Levels and Kinds of Evidence to Support Indications and Claims for Non-Registerable Medicines, including Complementary Medicines and other Listable Medicines.

TGA said in a statement it "intends to embed the document within the legislative framework for regulation of therapeutic goods in Australia," and that the document's recommendations have already been "agreed to in principle" when they were released in the report TGA Reforms: A blueprint for TGA's future.

The guideline's key features include:

  • clear separation of scientific evidence and evidence of traditional use;
  • guidance for sponsors about how to identify potential sources of evidence and how to assess evidence in terms of its relevance, quality, outcomes and consistency;
  • a quantitative approach to the review process and where possible, algorithms have been provided for sponsors to assess different characteristics of evidence;
  • a summary report template that must be completed and may be requested during listing compliance reviews;
  • that the assessment of evidence should be undertaken by an individual with clinical and critical appraisal skills; and
  • specific information (including a number of examples) relating to weight loss indications.

Read more:

TGA - Consultation document on levels and kinds of evidence to support indications and claims for listed medicines - feedback invited

TGA - Evidence required to support indications for Listed medicines (excluding sunscreens and disinfectants) - draft

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