Pharmacy Daily | TGA CM reforms rolling on

THE Therapeutic Goods Association is examining the sanctions and penalties associated with repeated breaches of its regulations, with Parliamentary Secretary for Health and Ageing, Catherine King, telling a Complementary Medicines Industry Leaders’ reception at Parliament House last night the move will “provide extra incentive to those sponsors who have not quite been at the level we require”. King outlined the current major reform process for the TGA, which will aim to increase compliance with regulatory requirements. She said the TGA was also looking at amending labelling of complementary medicine products, including clear explanation of the ‘AUST L’ number on these items. “It is the Government’s view that greater explanation of the regulatory arrangements for complementary medicines, including this labelling change, will enhance public faith in the regulator and be a positive step towards greater transparency,” King told the reception. A key part of the reforms will be close collaboration with the industry, and King confirmed that she had asked the TGA to establish the Therapeutic Goods Advisory Council which will oversee the implementation and evaluation of recommendations resulting from the transparency review. King said that the government “realises the importance of the complementary medicines industry to Australians, to our economy, and to the growing numbers of Australians who choose complementary medicines for their health and wellbeing”. Regulatory and cost recovery impact assesssment as well as amendments to the regulations will be required in some cases. “Increased compliance will reduce the criticism levelled at your industry and improve trust,” she said.

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