Snapshot

The Institutional Directive for the Registration of Orphan medicines or Biologics previously registered in a high surveillance country pathway has been developed by the of Peru.

This pathway can be used where Drugs and biologics destined to rare or orphan diseases and being part of the National List of Rare Diseases of the Ministry of Health Drugs and biologics destined to treat cancer and being registered in a High Surveillance country Drugs and biologics not included above .

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 Canada Denmark EU-EMA Germany Ireland Italy Japan Netherlands Norway Portugal South Korea Sweden United States

Target time assessment is 45 days.