The reforms to the regulation of complementary medicines will:

• support consumer health decisions by increasing the information available on the efficacy of complementary medicines; and
• improve transparency for both industry and consumers by establishing a catalogue of approved ingredients and a list of permitted indications for use in complementary medicines.

The reforms will also increase certainty of processes and increase flexibility for industry by:

• making greater use of assessments for ingredients by comparable overseas regulators;
• implementing an additional and new approval pathway for new complementary medicines;
• introducing statutory timeframes for the approval of new ingredients; and
• adopting a risk-based approach to the variations of complementary medicines.

In addition, a support service to assist Small and Medium sized Enterprises to navigate regulatory processes will be established, along with improved regulatory guidance information.

Transparency, predictability and safety

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

To further protect the public from inappropriate claims, there will be a significant increase in the number of listed complementary medicines subject to post-market review for compliance with the listing requirements.

A new class of complementary medicines will be introduced. Evidence for efficacy 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 as part of the 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.

Legislative timeframes for complementary medicine ingredient and product approvals will be introduced so as to increase certainty for industry.

To help maintain and further improve safety standards the TGA will enhance its post-market monitoring of complementary medicines through better use of adverse event reporting (including of interactions between complementary and prescription medicines), use of broader health data sets and through strengthening the sharing of intelligence with overseas regulators.

Reduced regulatory burden and encouragement of innovation

The TGA will develop, or adopt from overseas regulators, monographs for efficacy, safety and/or quality data for commonly used ingredients (e.g. vitamins). These monographs will document the evidence supporting the efficacy of these ingredients which will reduce the administrative burden on sponsors.

To reduce duplication of effort and improve approval timeframes, new approval pathways for complementary medicine ingredients and products will be established that make use of assessments by comparable overseas regulators. Greater emphasis on risk will be adopted in managing variations to existing complementary medicines.

To encourage innovation and further enhance the competitiveness in the complementary medicine sector the Australian Government will consider options for provision of new incentives for innovation.