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Australia Says Yes To Using Assessments Reports From Key International Regulators

 
• By Neena Brizmohun

Prescription medicines could be approved faster in Australia after the Therapeutic Goods Administration issued an initial list of overseas agencies whose assessments reports it is prepared to rely on.

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Australia will use drug assessment reports by comparable overseas regulators

Australia’s Therapeutic Goods Administration today published an initial list of overseas regulatory agencies that it deems are comparable and whose assessment reports for prescription medicines it will accept under its reformed mechanism for collaborating with its international counterparts and speeding up drug approvals.

Under a new comparable overseas regulators (CORs) report-based application process, the TGA will accept assessment reports by the European Medicines Agency (centralized and decentralized processes), Health Canada, Singapore’s Health Sciences...

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