Parliament closer to backing device regulation change

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Further reforms to the TGA have successfully navigated a portion of the parliamentary approval process but there are just three sitting days left in 2018.

The Bill implements a number of changes adopted as a result of the recent review of medicines and medical device regulation.

Speaking in the House of Representatives last night, health minister Greg Hunt said, "Medical devices will reach the market sooner through the greater use of comparable overseas regulator assessments afforded by this bill.

"In other words, this is the long-held objective of allowing us to adopt the best quality international regulatory findings and to bring them into the Australian system to help bring the devices into Australia earlier. Patients' lives will be prolonged, protected and improved through this process."

Under the Bill, 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.

The Bill is backed by Labor and includes a range of other changes, including a provisional approval scheme for medicines, under which breakthrough medicines for an unmet medical need will be granted approval for two years based on initial clinical trial data.