The Tunisian pharmaceutical industry is set to enter a new phase of digital transformation with the impending mandatory adoption of the electronic Common Technical Document (e-CTD) system, starting from January 1, 2027. This move aims to modernize the licensing procedures for medicines. However, it poses financial, technical, and regulatory challenges for several industrial institutions. A symposium was organized on October 8, 2026, by the National Pharmacists' Chamber, in partnership with the Ministry of Industry, Mines, and Energy.
The e-CTD system represents a unified digital format adopted by health authorities for submitting applications for marketing authorization, renewal, and changes to medicinal products. According to Tarek Hemami, representative of the National Pharmacists' Chamber, the initial implementation date was set for September 1, 2026, but was postponed to December 31, 2026, at the request of industry stakeholders. As a result, all submissions made from January 1, 2027, will be required to adopt the e-CTD system mandatorily.
Hemami explained that several institutions have already begun submitting their files in the new format, while others are still working to complete their preparations to meet the technical and regulatory requirements. The symposium, titled "The Tunisian Pharmaceutical Industry: Transition to the e-CTD System, Digitalization, and Sustainable Competitiveness," brought together industry stakeholders to discuss the challenges and opportunities presented by the new system.
The adoption of the e-CTD system is expected to enhance the efficiency and transparency of the licensing process for medicinal products in Tunisia. However, industry stakeholders have expressed concerns about the financial and technical implications of implementing the new system. The National Pharmacists' Chamber and the Ministry of Industry, Mines, and Energy are working together to support the industry in its transition to the e-CTD system.
The symposium highlighted the need for industry stakeholders to invest in digital infrastructure and training to ensure a smooth transition to the e-CTD system. Hemami emphasized that the successful implementation of the e-CTD system will depend on the collaboration and coordination of all stakeholders, including regulatory authorities, industry players, and service providers.
The Tunisian pharmaceutical industry is expected to benefit from the adoption of the e-CTD system, which will enable the country to align with international standards and best practices in the regulation of medicinal products. The implementation of the e-CTD system is also expected to improve the competitiveness of the Tunisian pharmaceutical industry in the regional and global markets.
Industry stakeholders have been advised to expedite their preparations to ensure compliance with the new regulatory requirements. The National Pharmacists' Chamber and the Ministry of Industry, Mines, and Energy will continue to provide support and guidance to industry stakeholders to ensure a successful transition to the e-CTD system.
Key points
- The e-CTD system will be mandatory for all medicinal product submissions in Tunisia starting from January 1, 2027.
- The implementation of the e-CTD system aims to modernize the licensing procedures for medicines in Tunisia.
- Industry stakeholders have expressed concerns about the financial and technical implications of implementing the new system.
