The Therapeutic Goods Administration (TGA) has provides an updated draft ‘Listed medicines evidence guidelines – How to demonstrate efficacy for listed medicines’ (the Guidelines), which is intended to replace the existing ‘Evidence guidelines – Guidelines on the evidence required to support indications for listed complementary medicines v 3.0, January 2019’.

Listed medicines are required to hold the appropriate evidence to substantiate the indication(s) being made for the medicine and being able to demonstrate to the TGA that the efficacy of the medicine is acceptable. The Guidelines set out the factors that the TGA considers when assessing the efficacy of a listed medicine. It therefore provides a roadmap to help sponsors put together an appropriate evidence package. In addition, it increases transparency and consumer confidence about the efficacy of self-selected medicines on the market.

The purpose of this update is to enhance the readability and utility of the Guidelines; clarify the way the TGA interprets and analyses the different types of evidence; and clarify specific technical concepts that have been problematic or unclear in the existing Guidelines. The update of the Guidelines is not intended to change the regulatory requirements for listed medicines and will not change the existing requirements to substantiate indications.

These guidelines are primarily for sponsors who base their medicine’s efficacy on publicly available published literature. It is intended to assist these sponsors to:

  1. Find evidence
  2. Critically assess evidence
  3. Select indications (as permitted for use in listed medicines) based on evidence
  4. Present evidence

An evidence package is expected to contain a persuasive critical appraisal of the collated body of evidence to demonstrate a listed medicine’s efficacy. The figure below shows the steps that are involved in compiling an evidence package.

The guide provides a detailed overview of the proposed new guidelines for presenting your evidence package.

You can download the full Draft Guidelines from here.