Snapshot

The TGA Comparative Overseas Regulator (COR)-B pathway has been developed by the Therapeutic Goods Administration (TGA) of Australia.

When relevant, the agency relies on prior decisions from Canada EU-EMA Japan Singapore Switzerland United Kingdom United States

Under the COR-B approach, the TGA regulatory decision will still be mostly based on a critical review of the COR assessment reports. The COR-B process has a 175 working day evaluation and decision timeframe, allowing for TGA evaluation of certain data, in addition to the label, PI and RMP.