The Ministry of Health (MOH) – Kuwait has issued Ministerial Decree No. (342) of 2025,  establishing the Regulatory Framework for Drug Approval for human medicinal products in Kuwait.

The document provides a comprehensive framework governing review pathways, approval processes, timelines, and post-approval obligations.

🔍 What’s new:

• Establishes a formal regulatory framework defining all drug review pathways applicable in Kuwait.
• Defines eight review pathways, including standard, fast track, priority, expedited, biosimilar, emergency use, rolling, and GHC-approved drug pathways, each with specific eligibility criteria and timelines.
• Introduces clearly defined assessment timelines, response cycles, and clock-stop mechanisms for each pathway.
• Formalizes approval types, including standard approval, conditional approval, and Emergency Use Authorization (EUA), with defined validity periods.
• Specifies post-approval obligations, renewal requirements, pricing considerations, and conditions for transition from conditional or emergency approvals to standard registration.

💡 Why it matters:

• Provides regulatory clarity on how and when different drug categories can access the Kuwait market.
• Enhances predictability for applicants by defining pathway-specific timelines, obligations, and approval validity.
• Supports structured decision-making for products addressing serious, life-threatening conditions or unmet medical needs.

📌 How ReguLinked can support you:

• Support pathway selection based on product profile and eligibility criteria.
• Assist with regulatory strategy planning for standard, accelerated, or emergency pathways.
• Support review of submission readiness, timelines, and post-approval obligations under MD No. 342/2025.

📎 Official PDF: Framework for human Drug Approval – Kuwait

📨 Planning to Submit New, Renewal or Variation application in Kuwait?

Let ReguLinked accelerate your submissions with a fully compliant with Kuwait requirements and strategy.

“Book your complimentary consultation today”

📧 bd@regulinked.com 🌐 www.regulinked.com

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