The Orphan Drug Route pathway has been developed by the Drug Administration of Vietnam (DAV) of Vietnam.

This pathway can be used where Orphan drugs; drugs for diseases with prevalence rate in a population at any point in time not exceeding 0.05% and of the following nature: genetic, congenital, cancer, autoimmune, communicable, and tropical infections; any vaccine, drug for estimated usage not exceeding 8,000 cases/year; a radioactive drug: a marker; and a drug which does not generate sufficient profit to cover local investment/marketing. .

When relevant, the agency relies on prior decisions from Australia EU-EMA Japan United States

If the drug is established for treatment of RD, it will serve as the basis for consideration to waive late phase research data (i.e., phase 3) and zone IVb stability data during drug registration. Waiver of above-mentioned requirements for drug registration only applied to RD drugs but not other "not readily available" drugs. If the drug is listed for RD or not readily available, priority will be granted during registration. However, it is not clear how much the regulatory approval timelines of OD registration will be shortened. Sponsors could propose potential OD and rare diseases to be included into the list but unclear when MoH would review and update.