Egypt has become the first African nation to achieve an advanced classification in the oversight of domestically manufactured drugs and vaccines, according to the Egyptian Drug Authority (EDA). The EDA highlighted the significance of this achievement, stating that it reflects Egypt’s commitment to ensuring the availability of safe, effective, and high-quality medical products.
Ali Al-Ghamrawy, head of the EDA, affirmed the authority’s dedication to international standards. “This high-level achievement is a result of Egypt’s commitment to ensuring the availability of safe, effective, and high-quality medical products,” he said.
In a statement, Al-Ghamrawy noted that the EDA has been developing institutional excellence indicators at the international level for the past five years, adhering to the latest global regulatory references. He added that ongoing modernisation and development across the EDA’s technical, administrative, technological, and regulatory functions have strengthened its prospects for obtaining numerous high-level international accreditations.
Al-Ghamrawy expressed gratitude to President Abdel Fattah El-Sisi for his support of the pharmaceutical sector. He said that Egypt’s attainment of advanced international accreditations is a direct result of the President’s patronage, directives, and continuous support for the Egyptian pharmaceutical industry.
The EDA head also lauded the cooperation between the EDA and the World Health Organization (WHO). He said the collaboration aims to advance the pharmaceutical manufacturing system in Egypt, maintain its regional leadership, and develop the Egyptian drug regulatory system.
Egypt obtained WHO accreditation at Maturity Level 3 for vaccines in March 2022, according to Al-Ghamrawy. Achieving the same level in the pharmaceutical sector proved to be a greater challenge but was successfully met in December 2024.
Al-Ghamrawy explained that this achievement stems from Egypt’s dedication to ensuring the availability of safe, effective, and high-quality medical products. The classification followed a formal, standardised assessment using the WHO’s Global Benchmarking Tool (GBT), which relies on over 250 indicators. Achieving Maturity Level 3 demonstrates a stable, effective, and integrated regulatory system, supporting Egypt’s national health priorities and contributing to sustainable development goals.
Al-Ghamrawy said that this accomplishment unlocks new export markets, attracts foreign investment, deepens the localisation of vaccine and biopharmaceutical manufacturing, enhances the global competitiveness of Egyptian pharmaceuticals, and reflects international confidence in the Egyptian regulatory system.
“This provides a strong boost for the future of the pharmaceutical industry in Egypt, strengthening the EDA’s leadership and solidifying its regional and international position,” he said.
Concluding his remarks, Al-Ghamrawy affirmed the EDA’s ability to continue fostering a conducive environment for the Egyptian pharmaceutical industry. He pledged to collaborate with international and local industry partners, as well as international organisations concerned with health and pharmaceutical affairs, to maintain the strength of the Egyptian drug market and ensure the continued supply of essential medical products to African, Arab, and global markets.
