Snapshot

The Fast Track Proceedings: ‘Article 4’ pathway has been developed by the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica of Argentina.

This pathway can be used where drug products with marketing authorization in at least one Annex 1 country. .

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from Australia Austria Belgium Brazil Canada Chile China Cuba Denmark Finland France Germany Hungary Ireland Israel Italy Japan Luxembourg Mexico Netherlands New Zealand Norway Spain Sweden Switzerland United Kingdom United States

Timeline for approval: about 10 months.