Senate inquiry into TGA changes

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Further reforms to the TGA have successfully navigated a portion of the parliamentary approval process but the Senate has established an inquiry into the Bill.

The inquiry is schdeuled to report on 2 February 2018.

The Bill establishes 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.

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

The Bill 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.

In a speech to the House of Representatives late yesterday, health minister Greg Hunt paid tribute to the sector's representative groups for supporting the Bill, which also has Labor's backing.

"This bill in particular, coupled with the recent amendments already enacted, will strengthen Australia's therapeutic goods regulatory framework," said Mr Hunt.

"It will ensure that it remains well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods. It makes Australia a more desirable destination for clinical trials. It helps make Australia a more desirable destination for manufacture and development of medical devices. We will receive better health outcomes and better economic outcomes as a result of these changes."

He continued, "I also want to acknowledge and appreciate the constructive work of the opposition. The opposition spokesperson, the member for Ballarat, has been a valued partner in this process, and I think it would be remiss of me not to acknowledge that."