Short timeline for Senate inquiry

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The christmas and new year period may be busier than expected for some because of the Senate inquiry into TGA changes.

The Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 was referred to the Senate Community Affairs Legislation Committee for inquiry and report last week.

The Bill establishes a scheme under which the work of comparable overseas regulators will be accepted as evidence when determining whether a medical device should be included on the Australian Register of Therapeutic Goods.

It creates the provisional approval scheme, scheduled for implementation early next year, under which breakthrough medicines for an unmet medical need will be granted approval for two years based on initial clinical trial data.

It also includes changes to the regulation of complementary medicines, reforms to streamline the advertising framework for therapeutic goods, and improved compliance and monitoring provisions designed to strengthen consumer protections.

The inquiry is due to report on 2 February, the Friday before the first sitting week of 2018, with 12 January as the closing date for submissions.

Liberal Party Senator Slade Brockman is chair of the committee. The deputy chair is Greens Senator Rachel Siewert.