Snapshot

The Abridged Procedure pathway has been developed by the Drug Administration of Vietnam (DAV) of Vietnam.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Austria Belgium Canada Denmark EU-EMA France Germany Ireland Japan Netherlands Sweden Switzerland United Kingdom United States

According to Circular No. 32/2018/TT-BYT, there are two abridged procedures applicable when registering drugs in Vietnam: a quick evaluation procedure and an abbreviated evaluation procedure. The timeline for these evaluation procedures is only six months from the receipt date of a complete drug registration dossier, while it is 12 months for the normal evaluation procedure.