Guidance for Orphan Drug Designation

Who the SFDA recognizes as a marketing authorization holder (MAH) — the manufacturing-site requirement, what foreign MAHs must set up locally, the difference between MAH, local agent, and scientific office, and how authorizations transfer…

What the SFDA Regulatory Framework for Drug Approval (Version 6.4) actually covers — the four registration pathways, verification against reference authorities, published review timelines, SDR submission rules, and what applicants are responsible for at every stage…

The Agency Registration Certificate required in SFDA drug registration is issued by the Saudi Ministry of Commerce, not the SFDA — what the certificate is, why the SDR application asks for it, who needs it, how to obtain it, and the mistakes that get files rejected…