The Ministry of Health (MOH) – Kuwait has issued Ministerial Decree No. (341) of 2025, issuing the “Content of the Registration Dossier for human pharmaceutical medicinal products”.

The decree defines the requirements for preparing and submitting CTD or eCTD dossiers to the Medicine and Medical Products Registration and Regulatory Administration, in alignment with ICH M4 (Modules 1–5) and regional requirements linked to the Gulf Health Council (GHC).

🔍 What’s new:

• Establishes CTD/eCTD (Modules 1–5) as the required dossier structure for pharmaceutical registration submissions and Introduces detailed Module 1 administrative requirements.
• Defines a comprehensive scope covering all human medicinal products, including new drug entities, generics, biological products, biosimilars, hormonal products, advanced therapy medicinal products (ATMPs), combination products, radiopharmaceuticals, and vitamins and minerals when intended for therapeutic use.
• Specifies review pathways applicable in Kuwait, including standard, fast track, priority, expedited, biosimilars, emergency use, rolling, and GHC-approved drug pathways.
• Defines types of regulatory approvals, including standard approval, conditional approval, and Emergency Use Authorization (EUA).

💡 Why it matters:

• Clarifies product eligibility, submission pathways, and approval mechanisms.
• Standardizes dossier preparation through alignment with international CTD/eCTD practices while maintaining Kuwait-specific administrative and ethical requirements.

📌 How ReguLinked can support you:

1. Assist with CTD/eCTD dossier structuring in line with Kuwait Module 1–5 requirements.
2. Support review of administrative and regulatory documentation, including certificates and declarations required under Module 1.
3. Provide regulatory guidance for selection of applicable review pathways and submission readiness.

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📎 Official PDF: KWU-CTD requirements

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

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

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

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