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TGA provisional pathway now assured
Posted 16 February 2018
The Senate has passed the TGA reform bill, ensuring the provisional pathway for new medicines recommended by the Sansom review will come into effect, most likely by the middle of this year.
A last-minute agreement between Labor and the government, brokered by Health Minister Greg Hunt, saw the bill through with a number of amendments including the retention of a pre-approval mechanism for OTC advertisements for two years, plus a review at 18 months.
The Sansom review had called for pre-approvals to be scrapped.
Although dissenters accused Labor of "caving in" to government pressure, the Labor side took credit for saving the legislation, saying: "Consumers will continue to have protection against dodgy claims about therapeutic goods, after the Turnbull Government was forced to back down and amend their own Therapeutic Goods Administration legislation."
Labor also noted the creation of the provisional pathway, saying it would allow patients with serious conditions access to medicines where the early clinical data is promising.
TGA national manager and deputy secretary for the Health Products Regulation Group in the Health Department, John Skerritt, has told industry he expects the provisional pathway to be implemented by mid this year. Approvals on early data will run for between 12 months and six years after which new data must be presented and a re-evaluation will occur.
"Importantly, promising new medicines will now have an expedited pathway so that patients can access the benefits of these medicines sooner. Better access to medicines is always a welcome step," Shadow Assistant Minister for Medicare, Tony Zappia said.
A Greens amendment aimed at complementary medicines stating: "All indications citing traditional evidence must include the following statement: This traditional indication is not in accordance with modern medical knowledge and there is no scientific evidence that this product is effective," was defeated.
Nick Lush
Posted 16 February 2018
The Senate has passed the TGA reform bill, ensuring the provisional pathway for new medicines recommended by the Sansom review will come into effect, most likely by the middle of this year.
A last-minute agreement between Labor and the government, brokered by Health Minister Greg Hunt, saw the bill through with a number of amendments including the retention of a pre-approval mechanism for OTC advertisements for two years, plus a review at 18 months.
The Sansom review had called for pre-approvals to be scrapped.
Although dissenters accused Labor of "caving in" to government pressure, the Labor side took credit for saving the legislation, saying: "Consumers will continue to have protection against dodgy claims about therapeutic goods, after the Turnbull Government was forced to back down and amend their own Therapeutic Goods Administration legislation."
Labor also noted the creation of the provisional pathway, saying it would allow patients with serious conditions access to medicines where the early clinical data is promising.
TGA national manager and deputy secretary for the Health Products Regulation Group in the Health Department, John Skerritt, has told industry he expects the provisional pathway to be implemented by mid this year. Approvals on early data will run for between 12 months and six years after which new data must be presented and a re-evaluation will occur.
"Importantly, promising new medicines will now have an expedited pathway so that patients can access the benefits of these medicines sooner. Better access to medicines is always a welcome step," Shadow Assistant Minister for Medicare, Tony Zappia said.
A Greens amendment aimed at complementary medicines stating: "All indications citing traditional evidence must include the following statement: This traditional indication is not in accordance with modern medical knowledge and there is no scientific evidence that this product is effective," was defeated.
Nick Lush
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