IMPLEMENTATION OF eCTD IN TUNISIA
IMPLEMENTATION OF eCTD IN TUNISIA
The statement regarding the implementation of eCTD has just been published officially by the National Agency for Medicines and Health Products (ANMPS) on the 28th of June 2024.
Tunisia is set to implement eCTD in 2025, with a transition period for online submissions (eSubmission), starting in January 2025. The full implementation is planned for 2026, with no paper submissions allowed after this date.
This move aims to optimize patient access to innovative treatments and reduce administrative processes.
Congratulations to Tunisia and the new agency for this achievement as Tunisia is the 2nd country in Africa to implement eCTD (after South Africa).
For more information, you can find the document published by the agency: http://www.dpm.tn/images/pdf/Communique-28062024.pdf