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Regulations and Requirements for Conducting Clinical Trials on Drugs (v4.0)

SFDA rules for drug clinical trials

Type	Regulation
Issuing authority	Ministry of Health (MOH)
Framework	Health data
Tier	Implementing & executive regulation
Legal status	In force
Instrument number	Saudi Food and Drug Authority (SFDA)
Issued	2026-05-10
Version	4.0
Dates	SFDA, version 4.0, 10 May 2026; current
Last verified	2026-10-20

The Saudi Food and Drug Authority (SFDA) Regulations and Requirements for Conducting Clinical Trials on Drugs (version 4.0, 10 May 2026) apply to sponsors and investigators running drug trials in the Kingdom.

• Trials must be registered in the Saudi Clinical Trials Registry (SCTR).
• Use of AI must be declared in submissions.
• Export of biological samples needs IRB permission under the research ethics law (M/59).
• Trial data about participants is health data, which is sensitive data under the PDPL.

Documents

• Official source (www.sfda.gov.sa)

Updates for this instrument

• 2026-05-10 · SFDA issues clinical trials regulations v4.0: The Saudi Food and Drug Authority (SFDA) issued version 4.0 of its Regulations and Requirements for Conducting Clinical Trials on Drugs on 10 May 2026: Saudi Clinical Trials Registry registration, AI use declared in subm

In this framework

• Law of Ethics of Research on Living Creatures and its Implementing Regulations
• Saudi Health Information Exchange Policies (IS0303 v1.0)
• MoH internal Data Governance Policy (v0.1)
• Saudi eHealth Security and Privacy Interoperability Specification (IS0101)
• Telehealth Application Guidelines
• Guidance on AI/ML-Enabled Medical Devices (MDS-G010)
• Guidance on Pre-Market Cybersecurity of Medical Devices (MDS-G38)

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Content and register data licensed CC BY 4.0. Cite the live URL. Machine-readable register (JSON) · Markdown register · Content last verified: 2026-10-21