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As such, the panel referred to the Centre for Innovation in Regulatory Science (CIRS) data showing the TGAs median approval time of 391 days in 2013fourth out of the six regulators assessed: FDA (USA), Pharmaceuticals and Medical Devices Agency (PMDA, Japan), Health Canada, EMA (EU) and Swissmedic (Switzerland) (median approval time 304, 342, 350, 478 and 511 days, respectively) [12]