Snapshot

The Conditional Approval for Medicinal Products for Human Use pathway has been developed by the of Saudi Arabia.

This pathway can be used where new medicines to address an unmet medical need in the treatment of a serious or life-threatening condition. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Assessment is the same as for the regular review process, although the clinical data provided as part of a submission for conditional approval may be preliminary, this does not mean that the evaluation workload would be less than for a standard submission for registration. SFDA will take into consideration the standard timetable agreed for the assessment procedure.