The Saudi Food and Drug Authority (SFDA) has issued its An important regulatory update for the pharmaceutical sector in Saudi Arabia

“Regulatory Guidance for Submissions and Applications,” effective 1 January 2027, replacing the previous Regulatory Framework for Drugs Submission AND Approval.

🔍 What’s New
The guidance provides pharmaceutical companies with a consolidated overview of SFDA drug submission pathways, assessment timelines, inquiry waves, response deadlines and post-approval procedures, supporting regulatory planning ahead of its implementation on 1 January 2027.

*Main Key Points
▪️ New Pathway-specific assessment targets Framework
▪️ Defined response deadlines for validation inquiries and 6 for assessment and pricing inquiries.
▪️ Critical quality, safety or efficacy deficiencies remaining unresolved after the second inquiry wave are grounds for rejection.
▪️ Performance targets cover actual assessment time only. Validation and the registration committee’s decision period are excluded, and the clock stops while applicant responses are awaited.

⏱️Timeline:
The accompanying infographic summarises the key timelines and milestones.

📌 How ReguLinked Can Support
1- Identify the appropriate registration pathway and assess eligibility.
2- Prepare submission dossiers, assess documentation readiness and coordinate responses to SFDA inquiries.

Planning to register a pharmaceutical product in Saudi Arabia?
Let ReguLinked support your regulatory readiness with an SFDA-aligned submission strategy.

Official source: https://shorturl.at/tDNuz

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