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Evidence guidelines

Guidelines on the evidence required to support indications for listed complementary medicines

1 February 2019

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Guidelines on the evidence required to support indications for listed complementary medicines

Note: These guidelines will be subject to a broad review in 2019 to improve the clarity and useability of the guidance for sponsors.

Who are these guidelines for?

These guidelines provide information for sponsors and applicants:

  • on the type of evidence that is required to support indications for listed complementary medicines; and
  • to help you understand your regulatory obligations in relation to holding evidence to support indications for your medicine.

Scope of guidelines

These guidelines provide information on the type of evidence that is required to support indications for medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act) (excluding sunscreen therapeutic products). The document is comprised of two parts:

While sunscreens are a listed medicine product type, there is currently separate guidance for these products provided in in the Australian Regulatory Guidelines for Sunscreens (ARGS).

Part A provides guidance on:

  • the types of indications and evidence sources
  • how to assess the relevance, quality and balance of scientific evidence
  • how to assess the credibility and relevance of evidence of traditional use; and
  • how to obtain, record and present the evidence that supports your indication/s.

Part B provides additional technical guidance:

  • to help you assess the relevance, quality, outcomes and overall balance of currently available scientific evidence; and
  • on the evidence required for indications relating to weight loss, biomarkers and nutritional supplementation.

Evidence package checklists are available on the TGA website to help you assess, record and present the available evidence for the indication/s for your medicine. Appendix 1 provides assistance for completing the checklists.

TGA disclaimers

  • This document is a guide only. It is the responsibility of each sponsor to understand and comply with the regulatory requirements contained in the Therapeutic Goods Act 1989 and supporting regulations. You are encouraged to seek your own professional advice to find out how therapeutic goods legislation and other applicable laws apply to you.
  • Indications used in these guidelines have been provided as examples only. These indications do not relate to actual medicines and whether there is evidence to support the indications has not been assessed by the TGA.
  • These guidelines reflect the TGA's approach to assessing evidence to support indications for listed complementary medicines. However, there may be specific circumstances that justify a departure from the evidence guidelines and in this situation the TGA will consider the merits of each case against the regulatory requirements.

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