Al-Ghamrawy: Regulatory Process Management System to Go Live by February 2027, with Full eCTD Implementation Targeted for Q1 2028
Dr. Ali Al-Ghamrawy, Chairman of the Egyptian Drug Authority, held a meeting with representatives of DAF, led by Eng. Basel Mubarak, Chairman of the Board of Directors, and representatives of EXTEDO, headed by Mr. Martin Schmid, the Company's CEO, in the presence of Dr. Tamer Elhossieny, Vice Chairman of the EDA. The meeting marked the launch of Phase II of the Electronic Common Technical Document (eCTD) project and forms part of the Authority’s ongoing efforts to advance digital transformation and modernize the regulatory ecosystem in line with the latest international standards.
Dr. Al-Ghamrawy emphasized that the eCTD project is one of the EDA’s most strategic initiatives within its vision to establish a fully integrated digital regulatory environment. He noted that the Authority is accelerating its digital transformation agenda to enhance the efficiency of regulatory processes, strengthen transparency and governance, and facilitate a more enabling business environment for investors.
He added that the project reflects Egypt’s commitment to modernizing the pharmaceutical regulatory infrastructure in accordance with global best practices, thereby supporting the localization of pharmaceutical manufacturing, strengthening pharmaceutical security, and reinforcing Egypt’s position as a leading regional hub in the pharmaceutical sector.
For their part, representatives of DAF and EXTEDO expressed their appreciation for the significant efforts exerted by the EDA to modernize the regulatory framework and adopt advanced digital solutions. They affirmed that the EDA has successfully established a progressive model for digital transformation in the regulatory and oversight domain.

They also commended the Authority’s strategic vision and the high level of professionalism and expertise demonstrated by the work teams, emphasizing that the collaboration represents a successful model of effective partnership aimed at supporting the sustainable development of Egypt’s pharmaceutical sector and enhancing its competitiveness at both regional and international levels.
The meeting featured extensive discussions on the various tracks of the project, including a review of the strategic and operational frameworks governing Phase II of the eCTD initiative. Discussions also covered implementation mechanisms, governance structures, project management arrangements, and targeted performance indicators to ensure effective coordination among all stakeholders and successful execution according to the established timelines.
The parties also agreed to conduct a series of intensive technical and governance workshops over five days. These workshops will focus on aligning multidisciplinary teams, reviewing implementation requirements, defining work priorities, and establishing target timelines, thereby enhancing the readiness of all stakeholders to efficiently advance the project through its subsequent phases.
Furthermore, the meeting confirmed the planned operational launch of the Regulatory Process Management (RPM) system by February 2027, alongside the full implementation of the Electronic Common Technical Document Standard Version 4.0 (eCTD v4.0) during the first quarter of 2028.
This will support the development of the pharmaceutical registration system and enhance the efficiency of regulatory services provided to the pharmaceutical sector.
These milestones are expected to support the modernization of the pharmaceutical registration system and enhance the efficiency of regulatory services provided to the pharmaceutical sector.
The EDA reaffirmed its commitment to adopting state-of-the-art digital solutions and building an advanced, efficient regulatory framework aligned with international best practices.
Such efforts contribute to strengthening the competitiveness of Egypt’s pharmaceutical sector and achieving the State’s objectives in digital transformation and sustainable development, ultimately ensuring the availability of safe, effective, and high-quality pharmaceutical products for Egyptian citizens.
This comes within the framework of the EDA’s strategy to promote digital transformation and further develop the pharmaceutical sector’s regulatory infrastructure, thereby enhancing the efficiency of regulatory procedures and adopting advanced digital systems that comply with international standards, ultimately improving the quality of services delivered to pharmaceutical industry stakeholders.