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New TGA pathway open by mid-2018
Posted 31 August 2017
Australia will have a provisional approval pathway within 12 months, the TGA has told industry, providing legislative changes go as planned.
TGA national manager John Skerritt says the new system, revealed earlier this year in response to the Sansom Review, would be implemented by mid-2018 with plans for it to be in place in the first quarter of next year.
The new pathway will allow medicines to be available in Australia prior to full ARTG-listing "on the basis of promising evidence from early data that the medicine is likely to provide a major therapeutic advantage in efficacy and/or safety over existing treatments that are fully registered", Skerritt said in a presentation to industry at the 2017 ARCS conference this month.
The provisional registration will be valid for a possible six years, after which sponsors will be required to submit post-market safety and efficacy data.
Medicines approved under provisional approval will be "re-evaluated for full registration when enough data is provided to confirm adequate safety and efficacy standards," industry was told.
While sponsors may be given as little as one year, the provision for more than two years provisional approval is more generous than Europe, where conditional licensing currently provides only one year with the option for the sponsor to renew.
It will be the second new pathway to market access to be introduced by the TGA in Australia in 12 months, with the TGA implementing a Priority Review pathway in July. Roche's Alecensa (alectinib) was revealed this week as the first drug offered access to the pathway.
The TGA's Prescription Medicine Authorisation Branch Assistant Secretary Adrian Bootes told the conference the Provisional Approval pathway was still under development, emphasising it would be available to new drugs or new indications for existing drugs only on promising evidence from early clinical data.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 31 August 2017
Australia will have a provisional approval pathway within 12 months, the TGA has told industry, providing legislative changes go as planned.
TGA national manager John Skerritt says the new system, revealed earlier this year in response to the Sansom Review, would be implemented by mid-2018 with plans for it to be in place in the first quarter of next year.
The new pathway will allow medicines to be available in Australia prior to full ARTG-listing "on the basis of promising evidence from early data that the medicine is likely to provide a major therapeutic advantage in efficacy and/or safety over existing treatments that are fully registered", Skerritt said in a presentation to industry at the 2017 ARCS conference this month.
The provisional registration will be valid for a possible six years, after which sponsors will be required to submit post-market safety and efficacy data.
Medicines approved under provisional approval will be "re-evaluated for full registration when enough data is provided to confirm adequate safety and efficacy standards," industry was told.
While sponsors may be given as little as one year, the provision for more than two years provisional approval is more generous than Europe, where conditional licensing currently provides only one year with the option for the sponsor to renew.
It will be the second new pathway to market access to be introduced by the TGA in Australia in 12 months, with the TGA implementing a Priority Review pathway in July. Roche's Alecensa (alectinib) was revealed this week as the first drug offered access to the pathway.
The TGA's Prescription Medicine Authorisation Branch Assistant Secretary Adrian Bootes told the conference the Provisional Approval pathway was still under development, emphasising it would be available to new drugs or new indications for existing drugs only on promising evidence from early clinical data.
Megan Brodie
megan.brodie@lushmedia.com.au
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