Snapshot

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

This pathway can be used where new chemicals, biologics.

It is an abridged review (a reliance pathway).

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.