Government to Improve Regulation of Therapeutic Goods

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PDF printable version of Government to Improve Regulation of Therapeutic Goods (PDF 22 KB)

08 December 2011

The Gillard government will introduce a comprehensive package of reforms for Australia’s Therapeutic Goods Administration (TGA) to ensure the regulation of medicines and medical devices is more effective and transparent.

Releasing TGA reforms: A blueprint for TGA’s future, the Parliamentary Secretary for Health and Ageing, Catherine King, said that several important reviews of the TGA regulatory system have highlighted a number of issues of concern to consumers, health professionals and the regulated industry.

"In recent times, the TGA has been hampered by concerns around transparency and an inability to tackle some of the core issues that concern consumers," Ms King said.

"These include the effectiveness of complementary medicines, their promotion and the adequate evaluation of some high risk medical devices," Ms King said.

“The reforms will enhance the regulatory framework, ensuring that it remains adaptable to community and industry expectations.

“They will also improve the Australian community’s understanding of the TGA’s regulatory processes and decisions and enhance public trust in the safety and quality of therapeutic goods."

Ms King said over the past 18 months the government has received more than170 public submissions across seven separate reviews into the operations of the TGA.

"The Government has taken these submissions on board and consulted widely on the suggested reforms with representatives from industry, health professional and consumer groups through the review processes," she said.

Ms King said reforms to the regulation of complementary medicines would be of particular interest to many Australians.

“While the TGA has always ensured that complementary medicines in Australia contain safe ingredients and are manufactured in safe facilities, there has been some lack of understanding in the community that the TGA does not test these low risk products for efficacy,” Ms King said.

“The planned reforms are designed to better inform the Australian community about the therapeutic products they use and strengthen the response to unsubstantiated claims on labels or in advertising.”

Ms King said the reforms would be implemented in stages, with the TGA working closely with consumers, health professionals and industry to ensure the new regulatory arrangements are appropriate, efficient and fully transparent.

“These reforms are well overdue and I am confident that the TGA will welcome the opportunity to strengthen understanding and compliance with its regulatory processes,” she said.

The TGA reforms: A blueprint for TGA’s future can be found at http://www.tga.gov.au/about/tga-reforms-blueprint.htm

For more information, contact the Parliamentary Secretary’s Office 02 6277 4230