Snapshot

The Orphan Drug Designation pathway has been developed by the of Saudi Arabia.

This pathway can be used where orphan drugs.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The procedure for orphan drug designation is as follows: 1. Sponsor submits a request to notify SFDA of intent to submit orphan drug designation application through Sdr.drug@sfda.gov.sa 2. Pre-submission SFDA meeting with sponsor 3. Submission of orphan drug designation (ODD) application by sponsor 4. Application validation by SFDA 5. Assessment and recommendations for orphan drug designation 6. Final decision to be adopted 7. Publication of public summary of ODD on SFDA website