Evidence guidelines

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

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24 July 2014

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

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.

How are complementary medicines regulated in Australia?

Therapeutic goods that are imported or manufactured for supply in Australia are required to be included in the Australian Register of Therapeutic Goods (ARTG) by the Therapeutic Goods Act 1989 (the Act) unless they are specifically exempted by the Therapeutic Goods Regulations 1990 (the Regulations).

Within the regulatory framework, complementary medicines are either listed or registered in the ARTG based on their ingredients and the indications made for the medicine. While some complementary medicines are registered, most are listed.

Listed medicines are considered 'low risk' medicines. The listing process allows for rapid market access for listed complementary medicines. Unlike registered medicines, the TGA does not evaluate listed medicines prior to inclusion in the ARTG.

Refer to the Australian regulatory guidelines for complementary medicines (ARGCM) for more information on the regulation of complementary medicines in Australia.

What are your regulatory obligations when you list a medicine on the ARTG?

Before you list a medicine in the ARTG, you must ensure that the medicine complies with all applicable regulatory requirements. When you apply to list your medicine via the online application portal1, you, as the sponsor of the medicine, must certify that the medicine meets the regulatory requirements of:

  • Section 26A(2)(a)-(k) of the Act; and
  • subsection 26A(3) of the Act if your medicine is manufactured outside Australia.

The range of regulatory requirements includes that:

  • your medicine only contains ingredients permitted for listed medicines
  • you hold evidence to support any indications and claims made about your medicine; and
  • the presentation of your medicine is not unacceptable.

In relation to evidence for your medicine, Section 26A of the Act provides that you must:

  • hold evidence to support your indications at the time the medicine was included in the ARTG
  • retain that evidence at all times while the medicine remains listed; and
  • provide that evidence to the TGA if requested to do so.

There are offences for making false statements in, or in connection with, a certification of any matter under subsection 26A(2) of the Act.

When will the TGA look at the evidence you hold for your medicine?

After listing in the ARTG, a proportion of listed complementary medicines are reviewed for compliance with the regulatory requirements. Your medicine may be selected for compliance review at any time after it is listed in the ARTG. For further information see Listed complementary medicine compliance reviews.

Briefly, a compliance review of a listed complementary medicine involves:

  • assessing information about the product against the relevant legislative requirements, including, where relevant, the certifications given by the sponsor at the time the product was listed; and
  • taking appropriate actions when a breach of the legislative requirements is identified.

If your medicine is selected for a compliance review, you will be required to provide necessary information to the TGA. Evidence provided to the TGA for an 'evidence-based listing compliance review' must be sufficient to address all relevant regulatory requirements.

The TGA may take regulatory action (including cancellation of the listing in accordance with section 30 of the Act), if it is found that any of the certifications (among other things) made at the time of listing were incorrect.

What are the types of evidence for listed medicines?

Evidence used to support indications for listed medicines is usually sourced from the available open literature, rather than from clinical trials specifically conducted with a particular medicine2.

Depending on the proposed indication, the evidence will be sourced from scientific literature or based on a history of traditional use.

What information do these guidelines contain?

The document is comprised of two parts:

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 Act 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 during compliance reviews. 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.
  • This document will evolve over time and updates and clarifications will be included as required.

Footnotes

  1. Refer to the Listed medicines application and submission user guide for information on the application and submission process
  2. If you wish to conduct clinical trials on your medicine - information is available from the National Health and Medical Research Council (NHMRC) website.

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