The Kuwait Ministry of Health (Kuwait MOH) has made an important leap forward in the pharmaceutical regulatory landscape by transitioning from the Common Technical Document (CTD) format to the Electronic Common Technical Document (eCTD). This move aims to streamline the submission process for new drug applications, enhancing efficiency and ensuring compliance with international standards.
- Start Date for eCTD Submissions: Beginning 2nd March 2025, the Kuwait MOH’s Pharmaceutical Department will officially begin accepting applications in the eCTD format. However, to facilitate a smooth transition, CTD submissions will still be allowed until 1st September 2025.
- Exclusive eCTD Submissions: After 1st September 2025, only eCTD submissions will be accepted by the Kuwait MOH. This marks a key step in modernizing regulatory practices, pushing for the adoption of more advanced digital systems.
- Baseline eCTD Submissions: From 2nd March 2025 to 1st March 2026, all applicants will need to submit baseline eCTD versions of previously submitted dossiers. This ensures that all past applications are aligned with the new electronic format, maintaining consistency across submissions.
- Harmonization with GCC Countries: This transition is part of a broader effort to harmonize regulatory processes across Gulf Cooperation Council (GCC) countries. By adopting eCTD, Kuwait is facilitating smoother cross-border trade and improving cooperation within the pharmaceutical sector.
This shift to the eCTD format reflects Kuwait’s commitment to modernizing its regulatory framework, aligning with international best practices, and improving the overall drug approval process.
Masuu Global is a leading provider of regulatory services, offering expert support in transitioning to the eCTD format. With extensive experience in regulatory submissions, Masuu Global helps pharmaceutical companies ensure compliance with Kuwait MOH’s new eCTD requirements. Their team provides end-to-end services, including dossier preparation, eCTD publishing, and timely submissions, ensuring a seamless process for clients navigating the regulatory landscape.