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The Egyptian Drug Authority (EDA) launches the second phase of the electronic Common Technical Document (eCTD) project in collaboration with EXTEDO and DAF
Dr. Ali El-Ghamrawy, Chairman of the EDA, held a meeting with representatives from EXTEDO, led by Martin Schmid, CEO and COO of cormeo, and DAF, led by Eng. Hatem Kandeel, CEO, to discuss ways to enhance cooperation and develop the digital system within the pharmaceutical sector.
The meeting was part of the EDA’s ongoing efforts to support digital transformation and update the eCTD-system. It marked the official launch of the second phase of the eCTD-project, reflecting the EDA’s commitment to implementing the latest international standards and developing pharmaceutical registration mechanisms in line with global systems.
The participants discussed ways to develop pharmaceutical databases, update registration and tracking mechanisms, and improve the efficiency of the electronic registration system. Their joint goal is to enhance the quality of services and expedite the approval process for pharmaceutical products in the Egyptian market.
Dr. El-Ghamrawy emphasized the EDA’s commitment to adopting the latest digital solutions in various sectors, in line with the state's vision for digital transformation and improving the pharmaceutical sector. He noted that the eCTD v4 project represents a significant step forward in the pharmaceutical registration process The second phase of the project enhances the development of a sophisticated digital infrastructure capable of managing data more efficiently and increasing compliance with international standards. This will allow faster decision-making as well as enhancing the competitiveness of the Egyptian pharmaceutical industry. Additionally, the second phase of the project enhances the development of a sophisticated digital infrastructure capable of managing data more efficiently and increasing compliance with international standards, thereby supporting faster decision-making and enhancing the competitiveness of the Egyptian pharmaceutical industry.
Representatives ofEXTEDO stated that the second phase of the project provides an opportunity to implement the latest global digital solutions in pharmaceutical data and document management, enhancing the accuracy and speed of registration, approval and tracking processes, and enabling work according to the highest standards of quality and transparency. They confirmed their commitment to providing continuous technical support to ensure the project's success.
DAF also praised the EDA's leading role in driving digital transformation, noting that the agency has developed an electronic registration system and built a strong digital infrastructure, thereby enhancing efficiency and supporting innovation in pharmaceutical data management. They confirmed their readiness to provide all forms of support to ensure the project's continued development and success.
This cooperation reflects the EDA's commitment to implementing a comprehensive vision for digital transformation in the pharmaceutical sector, contributing to enhanced efficiency, transparency, and quality of services provided to citizens, and positioning Egypt among the leading countries in implementing digital solutions in the pharmaceutical sector.
The meeting was attended by Dr. Tamer El-Husseini, Vice Chairman of the Egyptian Drug Authority (EDA); Dr. Yasin Ragaey, Assistant Chairman for Media and Investment Support and Supervisor of the Central Administration for Pharmaceutical Care; General Mohamed Tantawi, Advisor to the Chairman for Digital Transformation; Dr. Mohamed El-Khatib, Head of the Central Administration of the Chairman's Office; Dr. Amira Mahgoub, Head of the Central Administration for Inspection of Pharmaceutical Establishments; Dr. Osama Hatem, Chairman Associate for Policies and International Cooperation and Supervisor of the Central Administration for Pharmaceutical Policies; and Dr. Wedian Younes, Head of the Central Administration for Drug Control.
Also present were Fabio Boni, Health Authorities Accounts Manager for Europe, the Middle East, and Africa, representing EXTEDO; and Professor Dr. Safwat Hamad, Projects Manager, Dr. Nada Youssef, Quality Manager, Dr. Ingy Alaa, Commercial Manager, and Eng. Ayman Kamal, Planning Manager, representing DAF. This collaboration reflects the Egyptian Drug Authority’s commitment to implementing a comprehensive vision for digital transformation in the pharmaceutical sector, which contributes to enhancing efficiency, transparency, and the quality of services provided to citizens, and places Egypt among the leading countries in implementing digital solutions in regulatory bodies and the pharmaceutical industry.
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The Egyptian Drug Authority (EDA)
eCTD
EXTEDO
DAF