Tag archive

Regulation

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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publicHealth Canada · Canada · Updated Jul 15, 2026

Order Providing for Reliance on Foreign Regulatory Authority Decisions for Certain Drugs (Ministerial Reliance Order)

Urgency: High

Manufacturers must demonstrate that any variances from the foreign authorized drugs do not adversely affect safety or effectiveness when filing for deeming under this new framework.

Country ComplianceSignal ManagementRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead, QPPV

verifiedRegulatory action: Draft Guidance

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