Snapshot

The Registrations Under Special Conditions pathway has been developed by the of Argentina.

This pathway can be used where new active pharmaceutical ingredients (API/s) (not approved in Argentina), indicated for serious and/or rare diseases.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Argentina Austria Belgium Brazil Canada Chile Colombia Cuba Denmark France Germany Holland Israel Italy Japan Mexico Spain Sweden Switzerland United Kingdom United States

120 administrative business days. However, this time can be reduced to 45 days in the case of drugs approved in the United States, Japan, Sweden, Switzerland, Israel, Canada, Austria, Germany, France, Great Britain, Holland, Belgium, Denmark, Spain and Italy, or in countries recognized as a national regulatory authority by the Pan American Health Organization.