ASMI welcomes CM evidence proposal

Steps by the Therapeutic Goods Administration to strengthen the regulation of complementary medicines (CMs) have been welcomed by ASMI, the Australian Self-Medication Industry, which represents evidence-based non-prescription consumer healthcare products.

The TGA 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.

Executive director of ASMI Dr Deon Schoombie says the release of the draft paper should set the tone for a thorough examination of how CMs 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,’ Deon says.

‘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.’

The consultation paper specifies the type of evidence required to support indications made for listed medicines, and is intended to become part of the legislative framework.

This follows a recommendation of the Working Group on Complementary Medicines, a body comprising industry and stakeholders which has been lobbying for more rigour in the regulation of CMs.

Deon says the consultation process provides a platform to further the reform process, including:

• the benchmark needed to establish an evidence base for CMs;
• the need for greater compliance with the regulations through increased post-market surveillance;
• the issue of sanctions for those who persistently breach the existing regulations; and
• measures to address the lack of data protection on the evidence required to support applications for registration.

More information at www.asmi.com.au