Snapshot

The Expedited Pathway pathway has been developed by the of Israel.

This pathway can be used where New drugs that have been registered or received a positive opinion by: FDA, EMA, or Swissmedic. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

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

180 calendar days. (NB: the agency uses a clock-stop approach).