publicSaudi Food and Drug Authority (SFDA) · Saudi Arabia · Updated Jun 28, 2026
Regulations and Requirements for Conducting Clinical Trials on Drugs (Version 4.0)
Ensure compliance with updated SUSAR reporting timelines (15 days), notify SFDA of Phase IV trials within 20 working days post-IRB approval, and prepare for the financial fee of 15,000 Saudi Riyals for clinical trial evaluations.
Country ComplianceICSRRegulatory Intelligence Lead
SOP Impact3 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead, QPPV
verifiedRegulatory action: Regulation
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