The Orphan Drug Route pathway has been developed by the Philippine Food and Drug Administration (FDA) of Philippines.

This pathway can be used where Drugs, diagnostic kits, medical devices, and biological products..

It is an abridged review (a reliance pathway).

Orphan drug designation (ODD) status can be requested before or after new drug application to PH FDA. If DoH has granted ODD status, PH FDA is expected to prioritize review and registration of the drug. PH FDA has not specified how much shorter regulatory timelines will be compared to non-OD.