Changes being made to regulation of complementary medicines will:

• provide consolidated lists of permitted ingredients and permitted indications
• make greater use of assessments for ingredients and products by comparable overseas regulators
• implement an additional approval pathways for new complementary medicines which includes pre-market assessment by TGA of evidence for efficacy for listed medicines
• improve transparency for both industry and consumers by establishing a catalogue of approved ingredients and a list of permitted indications for use in complementary medicine
• introduce statutory timeframes for the approval of new ingredients
• adopt a risk-based approach to the variation of complementary medicines

Existing pathways which enable listing of a complementary medicine through sponsor self-declaration and registration of a complementary medicine through full TGA pre-market assessment will continue.

The reforms will:

• support consumer health decisions by increasing the information available on the efficacy of complementary medicines
• increase certainty of processes and increase flexibility for industry

Complementary medicines sponsors will decide which pathway they wish to follow.

No.

The intention of increasing the number of pathways is to reduce regulatory burden for industry and facilitate complementary medicines coming to market in Australia.

The TGA will retain responsibility for approving therapeutic goods in the Australian Register of Therapeutic Goods (ARTG).

No.

To help maintain and further improve safety standards the TGA will:

• increase the number of listed complementary medicines subject to post-market review for compliance with the listing requirements
• enhance its post market monitoring of complementary medicines through better use of adverse event reporting (including of interactions between complementary and prescription medicines)
• use broader health data sets and strengthen the sharing of intelligence with overseas regulators.

The new approval pathways for complementary medicine ingredients and products may make use of assessments by comparable overseas regulators whenever appropriate. The overseas assessment will not be automatically accepted by the TGA, it will use the assessment report as the basis for its decision. The use of overseas reports will help reduce duplication of effort by industry and improve approval timeframes.

The TGA will develop a searchable catalogue of approved ingredients for use in listed medicines that can be accessed on the TGA website by sponsors, healthcare professionals and consumers.

We will also develop a list of 'Permitted Indications' which sponsors must use to describe the permitted therapeutic uses for listed complementary medicines. In doing so, 'free text' will no longer be allowed when listing these products on the Australian Register of Therapeutic Goods (ARTG). Together, these proposals will reduce administrative costs for industry and protect consumers from potentially misleading therapeutic claims.

Criteria will need to be developed for identifying those overseas regulators we can work-share with, and those with assessments which can be used for this purpose.

A new class of complementary medicines will be introduced. Evidence for efficacy alone for these products will be evaluated by TGA prior to their market authorisation. Sponsors of these medicines will be able to make therapeutic claims, supported by the evidence, that go beyond those available for listed medicines but of a lower level than those allowed for registered medicines. Criteria for these medicines will be developed in consultation with sponsors, consumers and health care professionals.

For complementary medicines that have been assessed for efficacy alone as part of the pre-market authorisation process; sponsors will be able to use promotional material to indicate that a product has been assessed as efficacious. Implementation of this change will improve the evidence base of the sector and encourage innovation.

The reforms will be progressively rolled out by the TGA over the next 18 to 24 months, with new regulatory pathways for some medicines in place within 12 months.

• Fact sheet: Complementary medicines regulatory reforms
• Fact sheets on other reforms are available