Snapshot

The Abridged Procedure pathway has been developed by the Ministry of Health (MOH) Pharmaceutical Division of Israel.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

180 days (excluding periods of time in which the applicant responds to a MOH letter of deficiencies) for new medicinal products that are already registered or received a positive opinion by one of the following regulatory agencies: The Food and Drug Administration; The European Medicines Agency; The Swiss Agency for Therapeutic Products (Swissmedic). **Generic products that file for registration in Israel after receiving marketing authorisation from the Food and Drug Administration or by the European Medicines Agency, must be registered by the MOH within 70 days (as opposed to the standard examination period which is 270 days) (section 47A(a2)(2), Pharmacists Ordinance).