The Tunisian pharmaceutical industry is facing significant challenges as it transitions to a unified electronic technical file system, set to become mandatory by 2027. The system, known as e-CTD, is a digital platform that allows for the submission of marketing authorization requests for medicines. According to Tarek Hemami, representative of the National Pharmacological Industry Chamber, the transition poses substantial financial and regulatory hurdles for industry players. The new system requires significant investment in specialized software and equipment.
The e-CTD system was initially set to become mandatory on September 1, 2026, but was later postponed to December 31, 2026, at the request of industry players. As of January 1, 2027, all submitted files will be required to adhere to the new system. Hemami noted that several companies have already begun submitting their files in accordance with the new system, while others still face challenges in making the transition. The transition is part of a comprehensive plan to improve drug management in Tunisia.
The adoption of the e-CTD system requires significant investment in specialized software and equipment, including the acquisition of software for compiling and verifying files, as well as setting up a dedicated information server. The initial investment cost is estimated to be around 30,000 dinars. According to Hemami, 25 national manufacturers have invested in this equipment so far, while others are still in negotiations or planning to outsource to local specialized institutions.
The transition to the e-CTD system not only poses technical challenges but also requires strengthening regulatory affairs teams and allocating budgets for training. Additionally, companies must reprocess and restructure their accumulated old files, which requires significant effort from regulatory affairs teams. Hemami emphasized that the cost of these requirements makes them inaccessible to all industry players.
Despite the challenges, the adoption of the e-CTD system and digitalization is expected to provide opportunities for the Tunisian pharmaceutical industry to enhance its competitiveness and open up new avenues for growth and export. The system will unify procedures, reduce processing times for files, and provide better tracking of document updates.
The pharmaceutical sector in Tunisia currently comprises 48 licensed manufacturing facilities, which cover around 80% of the country's needs in terms of volume and 60% in terms of value. Tunisian pharmaceutical exports currently stand at around 100 million euros to nearly 25 countries, including Libya, West African countries, Gulf countries, and Europe.
The industry players believe that the transition to the e-CTD system will enhance the image of Tunisian-made medicines, facilitate their access to international markets, and support the competitiveness of Tunisian industry players in the face of foreign competition. The sector has significant potential for growth, which has yet to be fully realized.
Key points
- The Tunisian pharmaceutical industry faces significant challenges in transitioning to a unified electronic technical file system.
- The transition is expected to enhance the competitiveness of the industry and open up new avenues for growth and export.
- The sector has significant potential for growth, with current exports standing at around 100 million euros to nearly 25 countries.
