The electronic Common Technical Document (eCTD) system for drug submissions is being implemented by Tunisia’s National Agency for Medicines and Health Products (ANMPS). The regulatory process for pharmaceutical products will be digitized starting in January 2025 with the transition to online submissions (eSubmission).
The objective of this transition is to improve efficiency, decrease the reliance on paper-based submissions, and align Tunisia with international best practices in regulatory affairs.
- Transition Period (2025): Pharmaceutical companies will be required to submit regulatory documents electronically using the eCTD format from January 2025 as part of the transition period. Companies must adjust their processes to meet this requirement during the first phase of implementation.
- Full Implementation (2026): By 2026, the transition to eCTD will be fully complete. From this date onwards, no paper submissions will be allowed. To submit anything related to pharmaceutical products, the eCTD format must be used for all applications, amendments, renewals, and other submissions.
- Benefits of eCTD Implementation:
- Efficiency: The eCTD system is expected to streamline the regulatory submission process, reducing the time and effort required for the review of drug applications.
- Accuracy and Compliance: By using standardized electronic formats, the risk of errors in submissions is minimized, ensuring better compliance with regulatory requirements.
- Faster Approvals: With a more organized and accessible submission system, ANMPS can review applications more quickly, leading to faster approvals and quicker access to medications in the market.
- Environmental Impact: A shift from paper submissions to digital formats helps reduce the environmental impact of regulatory processes.
- Regulatory Alignment: The move to eCTD aligns Tunisia with global regulatory standards, including practices adopted by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and other regulatory bodies.
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