RegulinkedKuwait MoH issues “Guideline on the Preparation & Submission of eCTD Dossiers” (2025).
🔍 What’s new:
Kuwait’s Ministry of Health has mandated the electronic Common Technical Document (eCTD) as the standard dossier format for New Drug Applications (NDAs) start from September 2025.
Key Elements:
* From 1 September 2025 onward, only eCTD submissions will be accepted through the designated portal.
* A baseline eCTD submission is required before submitting any renewal or variation application.
* The baseline eCTD implementation phase will run from 2 March 2025 to 1 March 2026, during which applicants are encouraged to submit all five CTD modules (1–5) or at least Modules 1 and 3.
*Module 1 must comply with the Gulf Health Council (GHC) eCTD specifications.
💡 Why it matters:
The introduction of eCTD requirements represents a key regulatory milestone in Kuwait’s move toward digitalization of pharmaceutical registration. It standardizes dossier format and structure, enhances alignment with GHC regional specifications, and enables faster, more consistent review cycles by the Ministry of Health.
📌 How Regulinked can support you:
• eCTD conversion & publishing: convert legacy CTD packages into eCTD sequences, prepare the XML backbone and perform validation checks.
• Module-1 regionalization: prepare Kuwait-specific Module-1 content and ensure compliant regional metadata.
• Dossier QC & pre-submission review to minimize requests for information or rejections.
• Training & process implementation: hands-on training for RA teams, SOPs for eCTD lifecycle management, and long-term publishing support.
📨 Preparing to submit to Kuwait’s MoH under the new eCTD requirement? ReguLinked will make your submission reviewer-ready and reduce time-to-approval.
Book your complimentary consultation today
📧 BD@regulinked.com | 🌐 www.regulinked.com
Attached the official update here: eCTD Memo – Kuwait
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