eCTD-Pharma Tunisia

The National Agency for Medicines and Health Products (ANMPS) in Tunisia has defined the following roadmap for the mandatory implementation of the eCTD:

• 1° April 2026: From this date, electronic submission becomes mandatory for new Marketing Authorisation (MA) applications, renewals, variations and transfers (eCTD or e-submission)

• 1° June 2026: eCTD Exclusivity: From this date, all regulatory submissions must be filed exclusively in eCTD format.

• Pending questions: Marketing Authorization (MA) applications submitted after January 1, 2025, and not yet evaluated, must be resubmitted in eCTD format, with a deadline of June 30, 2026.

Tunisia thus joins South Africa and the ECOWAS nations in adopting the eCTD standard, completing the transition to a digital regulatory model and eliminating paper submissions.

Gruppo SASI is fully prepared to support companies in this new scenario.

Our software eCTD-Pharma is operational and already configured for the management and submission of eCTD dossiers in Tunisia , ensuring a certified submission process to the competent authorities.