Snapshot

The TGA Comparative Overseas Regulator (COR)-A 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 COR-A, the TGA regulatory decision will be based on a critical review of the COR assessment reports and an evaluation of the Australian label, Product Information (PI) and where required, the Risk Management Plan (RMP). The evaluation and decision timeframe for COR-A applications is 120 working days.