Proposed update to evidence guidelines for listed medicines

Closed 1 Apr 2022

Opened 3 Mar 2022

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on the updated ‘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 do not undergo pre-market assessment but are subject to post-market compliance reviews that determine whether these medicines comply with the relevant regulatory requirements for listing. This includes holding 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. Nevertheless, it is inevitable that some clarifications may appear to be a change to some readers, given that the previous lack of clarity would have resulted in different interpretations.

The purpose of this consultation is to provide an opportunity for relevant stakeholders and interested parties to provide feedback on the content, presentation, and usability of the updated Guidelines.

Why your views matter

The TGA is requesting feedback to help refine the proposed update to the Guidelines.

To assist sponsors with this consultation, the TGA will be providing two webinars during the consultation period to outline the proposed changes to the Guidelines and give an opportunity for interested parties to give early feedback on the update. Information on the webinars will be published on the TGA website.

Audiences

  • Health professionals
  • General public
  • Complementary medicines

Interests

  • Non-prescription medicines