Phase I - an Important Foundation and Complete Success
With the project launch for the electronic Common Technical Document (eCTD) implementation in Phase I, the EDA has begun 2025 with a milestone in Egypt’s digital transformation of pharmaceutical regulation. The implemented health authority reviewing solution for eCTD and the submission portal support the acceleration of pharmaceutical registration processes in Egypt, transitioning their workflows towards a fully digital system. The seamless two-way communication between authorities and industry streamlines submission and review processes and, therefore, enhances efficiency and compliance.
Following on from Phase I – Advanced Solutions for EDA
The new project builds on the ongoing implementation of eCTD v3 and sets the foundation for eCTD v4, whose rollout is being actively driven forward with strong commitment by the EDA.
With the start of Phase II, the Egyptian Drug Authority will extend its regulatory infrastructure once again. The EXTEDOpulse Agency Portal powered by CARA will further expand the bi-directional portal solution. In addition, the Master Data Management, Regulatory Procedure Management, and Document Management will take EDA another significant step towards Egypt’s digital transformation of pharmaceutical regulation.
A Reliable Ally for Egypt’s Digital Transformation
“This partnership affirms EXTEDO’s global standing as a trusted collaborator for regulatory authorities and organizations. Backed by its innovative approach and extensive expertise, EXTEDO is well positioned to support the digital transformation of regulatory processes, ensuring safety, efficiency, and compliance”, says Martin Schmid, CEO of EXTEDO.
Together, Digital Access to Finance and EXTEDO are committed to a long-term partnership with the Egyptian Drug Authority, supporting their digital evolution for a healthier tomorrow.
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 Digital Access to Finance
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.