ASMI welcomes consultation on next step to strengthen complementary medicines regulation

26 April 2012

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The Australian Self-Medication Industry (ASMI), the industry body representing evidence based non-prescription consumer healthcare products today welcomed steps by the Therapeutic Goods Administration (TGA) to strengthen the regulation of complementary medicines (CMs).

The TGA has issued a draft discussion paper, Evidence required to support indications for listed medicines', which outlines the nature of evidence required to support health claims made for CMs. Specifically, the document is aimed at clarifying requirements for sponsors and improving the Australian community's understanding of the TGA's regulatory processes and decisions and enhancing public trust in the safety and quality of therapeutic goods. The document specifies the type of evidence required to support indications made for listed (low risk) medicines and is intended to replace the 'Guidelines for Levels and Kinds of Evidence to Support Indications and Claims for Non-Registerable Medicines, including Complementary Medicines and other Listable Medicines'.

The TGA intends to embed the document within the legislative framework for regulation of therapeutic goods in Australia. This reflects a recommendation of the Working Group on Complementary Medicines, a group made up of industry and stakeholders who have been lobbying for more rigor in the Complementary Medicines regulatory framework. It was also agreed to in-principle by the Government in TGA Reforms: A blueprint for TGA's future.

The Executive Director of ASMI, Dr Deon Schoombie, said the release of the draft paper should set the tone for a thorough examination of the way that complementary medicines are positioned in the Australian market.

"If consumers are to have faith in the rapidly growing complementary medicines industry, there needs to be a high level of confidence, rigour and transparency around the way that complementary medicines are marketed, including the health claims that are made about individual products.

"ASMI has long argued for appropriate regulation of the sector, with more accurate and timely advice to the public that helps to protect the credibility of those products that are proven and evidence-based.
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About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. ASMI's mission is to promote better health through responsible self-care. This means ensuring that safe and effective self-care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health strategy. www.asmi.com.au

Media contact: Bob Bowden, Foresight Communications (02) 9241 2811, 0412 753 298