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TGA faster, slicker in FY18
Posted 28 September 2018
The TGA's official annual report has shown off a faster regulator after the last financial year saw it introduce a raft of new programs.
The regulator named its new pathways as highlights of 2017-18, including the priority and provisional programs. It also mentioned orphan drug reforms, new special access schemes, and a pathway for approvals using shared reports from overseas regulators.
Compared to the previous financial year, the regulator shaved 15 days off the average time for a new drug approval, while it also cut 13 days off its average extension process times, according to the report. (see graph).
Credit: TGA
It said around 14 medicines had been granted priority review between July 2017 to June 2018, while two drugs had received provisional approval since the program's implementation in May.
Priority review medicines were approved over a median of 98 working days, it said.
It also mentioned its new orphan drug reforms, calling the program "fairer" despite recent criticisms the designations did not last long enough for drugs to have their fees waived for PBAC submissions.
Around 16 orphan drugs were designated during the 2017-18 financial year, a much smaller figure compared to 29 in 2016-17 - likely due to the more stringent application requirements for the new program.
However prior to 2016-17, orphan drug designations had been on a steady rise, increasing over a third from 2013, reflecting the larger number of the drugs entering the market.
According to a sales forecast report released by EvaluatePharma in May, orphan therapies are expected to make up a fifth of prescription sales by 2024 around the world.
The TGA also mentioned new OTC applications were "substantially higher" last financial year compared to the previous year.
Meanwhile it also saw an increase in compliance and investigation issues by 3.2 per cent compared to the year before.
Yajun Ma
Posted 28 September 2018
The TGA's official annual report has shown off a faster regulator after the last financial year saw it introduce a raft of new programs.
The regulator named its new pathways as highlights of 2017-18, including the priority and provisional programs. It also mentioned orphan drug reforms, new special access schemes, and a pathway for approvals using shared reports from overseas regulators.
Compared to the previous financial year, the regulator shaved 15 days off the average time for a new drug approval, while it also cut 13 days off its average extension process times, according to the report. (see graph).
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| Credit: TGA |
It said around 14 medicines had been granted priority review between July 2017 to June 2018, while two drugs had received provisional approval since the program's implementation in May.
Priority review medicines were approved over a median of 98 working days, it said.
It also mentioned its new orphan drug reforms, calling the program "fairer" despite recent criticisms the designations did not last long enough for drugs to have their fees waived for PBAC submissions.
Around 16 orphan drugs were designated during the 2017-18 financial year, a much smaller figure compared to 29 in 2016-17 - likely due to the more stringent application requirements for the new program.
However prior to 2016-17, orphan drug designations had been on a steady rise, increasing over a third from 2013, reflecting the larger number of the drugs entering the market.
According to a sales forecast report released by EvaluatePharma in May, orphan therapies are expected to make up a fifth of prescription sales by 2024 around the world.
The TGA also mentioned new OTC applications were "substantially higher" last financial year compared to the previous year.
Meanwhile it also saw an increase in compliance and investigation issues by 3.2 per cent compared to the year before.
Yajun Ma
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