Research Australia supports TGA reforms

Research Australia made a submission to the Senate Committee inquiring into the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017. This Bill is the latest instalment in amendments to implement the recommendations of a Review conducted in 2015 with the aim of improving the processes for the approval of medicines and medical devices by the Therapeutic Goods Administration (TGA), and to provide consumers with better information.

Research Australia supported the amendments to improve access to potentially lifesaving medicines for patients with few or no other options. In doing so, it will implement a scheme that is similar to those already operating in the USA and European Union.

Research Australia also supported the proposed changes to the marketing of complementary medicines, although we urged the Senate Committee to recommend the legislation be amended to include disclaimers to the effect that the efficacy claims for the products have not been independently assessed and/or are based on traditional use rather than scientific evidence.

Research Australia Submission on the TGA amendments.

The Senate Committee issued its Report on 2 February, noting Research Australia’s submissions. It has recommended that the Senate pass the Bill. In responding to concerns raised by the Committee about advertising of complementary medicines, the Department has outlined measures that will be taken to ensure the public is aware that efficacy claims are based on traditional use rather than scientific evidence. The Committee has also urged the Government to ensure the TGA is adequately resourced to undertake its monitoring activities.

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