We are delighted to announce that the Egyptian Drug Authority (EDA) has officially launched Phase II of its strategic digital transformation project, in collaboration with EXTEDO and its local partner, DAF for digital solutions. This next step in the EDA’s ambitious project represents a significant leap forward in modernising Egypt’s pharmaceutical regulatory infrastructure and will support the EDA in achieving its goal of reaching World Health Organization Maturity Level 4.
Phase I focused on the implementation of electronic Common Technical Document (eCTD) version 3. This milestone enabled EDA to transition from paper-based regulatory processes to a fully digital submission and review environment. The additional deployment of the health authority review solution and submission portal created seamless two-way communication between the EDA and the pharmaceutical industry, accelerating drug registration timelines and improving compliance.
In Phase II of the joint project, the EDA is building on its efforts to modernise regulatory processes in Egypt. This will be handled using a two-step approach. First, the core functionality will be delivered to support the EDA’s end-to-end process. Then, additional enhancements and improvements will be made to maximize the authority's daily regulatory operations.
By laying the groundwork for eCTD v4, the EDA is ensuring compatibility with the upcoming global standard, which it is driving forward with great determination. Furthermore, during this project stage, the EDA will introduce advanced solutions designed to streamline regulatory workflows within a Regulatory Procedure Management system that consists of:
Together with a Master Data Management, EDA is completely equipped to reach another significant step towards Egypt’s digital transformation of pharmaceutical regulation.
All capabilities will allow the EDA to manage their regulatory procedures more efficiently, ensure data integrity, and offer faster, more transparent interactions with industry stakeholders. Thus, EDA is setting a benchmark for regulatory excellence, not only within the region itself but also on a global scale.
Long-Term Partnership for a Healthier Future
EXTEDO CEO and cormeo COO, Martin Schmid, emphasizes the importance of this milestone:
'Phase II reflects our shared vision with the EDA to create an innovative and forward-looking regulatory environment in Egypt. We are grateful for EDA's trust in us for these significant developments. Alongside our esteemed local partner, DAF for digital solutions, we are dedicated to ensuring that EDA meets global standards while improving safety, efficiency, and compliance.”
This is in line with EXTEDO’s mission of empowering regulatory authorities and companies worldwide to support compliance and improve public health. We are excited to continue accompanying EDA on this journey and look forward to further milestones that will shape the future of regulatory affairs in Egypt.
EXTEDO CEO Martin Schmid together with Dr. Ali Ghamrawy, Chairman of the Egyptian Drug Authority (EDA) at the official launch of the joint project in Cairo.
About EXTEDO
EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). With our Regulatory Information Management Solution Suite EXTEDOpulse, we provide end-to-end solutions focusing on optimizing and streamlining our clients’ regulatory, quality, and safety information management processes. Today, EXTEDO enables more than 35 regulatory authorities and over 1000 maintained customers across 65 countries to deliver Effortless Compliance™.
About DAF for digital solutions
DAF for digital solutions (DAF) is a financial technology company committed to advancing financial inclusion through innovative, secure, and accessible digital solutions. By harnessing cutting‑edge technology, DAF facilitates access to credit, savings, payment systems, and other essential financial services. The company’s mission is to promote economic empowerment and sustainable growth by making financial services more transparent, efficient, and widely available.
For more information, visit www.dafholding.com.