Egypt’s pharmaceutical sector has witnessed remarkable growth in recent years, marked by a series of structural reforms and strategic investments. This progress culminated in a significant milestone: the Egyptian Drug Authority (EDA) has been officially awarded Maturity Level 3 (ML3) certification by the World Health Organization (WHO)—a globally recognized benchmark affirming that Egypt’s regulatory system for medicines and vaccines is stable, effective, and fully functional.
First Country in Africa Attaining Regulatory Maturity
Dr. Khaled Abdel Ghaffar, Deputy Prime Minister and Minister of Health and Population, described the certification as a landmark achievement for Egypt, making it the first country in Africa to attain this level of regulatory maturity. He emphasized that this global recognition would strengthen investor confidence, open new markets for Egyptian pharmaceuticals, and pave the way for expanded exports across Africa, the Arab region, and the Eastern Mediterranean.
The WHO assessment followed a rigorous benchmarking process, conducted by international experts using over 260 performance indicators, covering core regulatory functions such as product licensing, laboratory testing, post-market surveillance, and adverse event reporting.
Rapid Market Growth and Solid Industrial Base
According to Dr. Ali El-Ghamrawy, Head of the Egyptian Drug Authority, Egypt’s pharmaceutical market has been expanding at a compound annual growth rate (CAGR) of 15% between 2023 and 2028. The institutional pharmaceutical market alone is valued at EGP 94 billion with 0.6 billion units sold, while the broader domestic market has reached 2.9 billion units, valued at EGP 215 billion. The total market value now exceeds EGP 309 billion, positioning Egypt as the largest pharmaceutical market in the Middle East.
Currently, Egypt has 179 licensed pharmaceutical factories, 150 medical supply manufacturers, 130 cosmetics production facilities, and 5 factories for active pharmaceutical ingredients (APIs), with a combined total of 2,370 production lines nationwide.
Export Ambitions: $3 Billion Target by 2030
Egypt’s pharmaceutical exports hit $1 billion in the last fiscal year, with a goal to triple exports to $3 billion by 2030. Egyptian medicines are currently exported to over 147 countries, and the country is working to expand access to additional international markets through improved regulatory credibility and investment in high-tech pharmaceutical production.
Advancing Local Manufacturing and National Drug Security
El-Ghamrawy emphasized the state’s commitment to localizing the production of advanced medicines, particularly oncology treatments and insulin, to secure self-sufficiency and strengthen national pharmaceutical security. He noted the government’s focus on technology transfer and public-private partnerships to drive innovation, build capacity, and modernize infrastructure.
This effort includes launching a new Sustainable Green Industry Program, which encourages environmental compliance across pharmaceutical manufacturers. The Ministry of Environment has already allocated EGP 150 million in funding to support sustainable industrial practices.
Supply Chain Oversight and Drug Availability
Egypt has also made major strides in ensuring drug availability, with over 95% of medicines currently in stock. According to El-Ghamrawy, every registered drug has alternatives or equivalents, with more than 12,000 substitute products available in the local market. He confirmed that the country is no longer experiencing drug shortages, thanks to a combination of supply chain digitization, real-time tracking, and proactive regulatory oversight.
To combat counterfeit drugs and market manipulation, Egypt has implemented a national drug traceability system, allowing authorities to track every medicine box from production to point-of-sale—further enhancing market transparency and consumer safety.
Global Recognition and Regional Leadership
By achieving ML3 status, Egypt becomes the 15th country globally to receive this level of WHO accreditation, joining the ranks of top-performing regulatory systems worldwide. This milestone not only affirms the strength of Egypt’s pharmaceutical governance but also cements the Egyptian Drug Authority’s position as a leading regulatory body in the region.
The certification expanded market access, and further integration into global pharmaceutical supply chains—supporting Egypt’s broader vision to become a regional hub for pharmaceutical innovation, manufacturing, and regulation.
