Dr. Ali El-Ghamrawy, Chairman of the Egyptian Drug Authority (EDA), affirmed that over the past five years, the Authority has worked diligently to establish internationally recognized indicators of institutional excellence by aligning its operations with the latest global regulatory and oversight frameworks. He emphasized that the continuous modernization and development undertaken across the Authority’s technica
administrative, technological, and regulatory functions have significantly enhanced its ability to attain a number of prestigious international recognitions.
Dr. El-Ghamrawy expressed his profound appreciation for the unwavering support and exceptional attention devoted by His Excellency President Abdel Fattah El-Sisi, President of the Arab Republic of Egypt, to the pharmaceutical sector. He noted that Egypt’s attainment of advanced international recognitions has been made possible
through the President’s continued guidance, support, and commitment to advancing the Egyptian pharmaceutical industry.
He also commended the close collaboration and effective coordination between the Egyptian Drug Authority and the World Health Organization (WHO), which have contributed to strengthening Egypt’s pharmaceutical ecosystem, preserving the country’s regional leadership, and advancing the Egyptian medicines regulatory system.
In this context, Dr. El-Ghamrawy highlighted that Egypt successfully attained the World Health Organization’s Maturity Level 3 (ML3) designation for vaccines in March 2022. He noted that achieving the same level of recognition in the medicines sector represented the next major milestone—a goal that was successfully accomplished in December 2024.
The Chairman explained that this distinguished achievement reflects Egypt’s steadfast commitment to ensuring the availability of safe, effective, and high-quality medical products. The designation was granted following a formal benchmarking assessment conducted using the WHO Global Benchmarking Tool (GBT), which evaluates national regulatory systems against more than 250 indicators. Achieving Maturity Level 3 demonstrates the existence of a stable, integrated, and well-functioning regulatory system and represents a significant contribution to supporting Egypt’s national health priorities and the achievement of the Sustainable Development Goals.
Dr. El-Ghamrawy further noted that Egypt has become the first African country to attain this advanced level of regulatory maturity for both locally manufactured medicines and vaccines. He emphasized that this milestone opens the door to new export markets, attracts substantial foreign investment, and supports the localization of vaccine and biopharmaceutical manufacturing. Moreover, it strengthens the global competitiveness of Egyptian pharmaceutical products and reflects the international confidence placed in the robustness of Egypt’s regulatory framework, providing strong momentum for the
future of the pharmaceutical industry and reinforcing the Egyptian Drug Authority’s regional and international standing.
In his concluding remarks, Dr. El-Ghamrawy reaffirmed the Egyptian Drug Authority’s commitment to maintaining an enabling environment for the continued growth and success of the Egyptian pharmaceutical sector. He underscored the Authority’s determination to work closely with domestic and international industry partners, as well as international health and pharmaceutical organizations, to safeguard the resilience of the Egyptian pharmaceutical market and ensure the uninterrupted supply of essential medical products to African, Arab, and global markets.