Following Africa Health ExCon 2026, Business Monthly sat down with Dr. Ali El-Ghamrawy, Chairman of the Egyptian Drug Authority (EDA), to discuss recent developments in Egypt’s pharmaceutical sector. The conversation covers regulatory standards, manufacturing and exports, localization efforts, digital transformation, and the EDA’s priorities through 2030.
The Q&A has been edited for length and clarity.
Business Monthly: Egypt has set an ambitious goal of becoming a regional pharmaceutical manufacturing and export hub. What are the key priorities driving this strategy, and what role does the Egyptian Drug Authority play in achieving it?
Dr. Ali El-Ghamrawy: Egypt’s pharmaceutical sector has entered a new phase of growth. By the end of 2025, the market reached approximately 4 billion medicine packs valued at EGP 422 billion ($8.48 billion), up 37% from 2024. First-quarter 2026 sales totaled EGP 109.9 billion ($2.21 billion), maintaining annual growth of around 15%.
To sustain that momentum, we’re creating a predictable and transparent regulatory environment that attracts investment. Through the EDA’s Investment and Export Incentives Guide, we’re offering fast-track registration pathways, localized pricing incentives, and a regulatory framework that supports innovation.
Our ambition is to establish Egypt as a trusted regional center for pharmaceutical manufacturing, regulation, and innovation serving Africa and the Middle East.
BM: Egypt recently achieved WHO Maturity Level 3 for medicines and vaccines. How is this milestone boosting investor confidence and creating new opportunities for pharmaceutical exports?
El-Ghamrawy: WHO Maturity Level 3 confirms that the EDA operates a stable, transparent, internationally recognized regulatory system, strengthening confidence among multinational pharmaceutical companies and investors.
The EDA also became a full member of the United States Pharmacopeia (USP), giving Egypt voting rights in shaping international pharmaceutical standards. In addition, the World Health Organization designated the EDA’s Continuous Professional Development Center as a Regional Biomanufacturing Training Hub for the Eastern Mediterranean, making Egypt one of only seven accredited centers globally.
The impact is already visible. Pharmaceutical exports reached approximately $1.3 billion by the end of 2025, while first-quarter 2026 exports rose 7% year on year to $280 million. Egypt is targeting $3 billion in pharmaceutical exports by 2030, including $1.34 billion to African markets.
To support this goal, the EDA introduced the Manufacturing for Export framework, cutting regulatory approval times by more than half through fast-track pathways and helping unlock capacity across Egypt’s 183 licensed pharmaceutical factories.
BM: Africa Health ExCon 2026 resulted in several new partnerships across the continent. How do these agreements support Egypt’s ambition to become Africa’s pharmaceutical gateway?
El-Ghamrawy: This year, the EDA signed cooperation agreements with Algeria’s National Agency for Pharmaceutical Products (ANPP), the Somali Medicines Regulatory Authority, and Sierra Leone’s Pharmacy Council to harmonize regulatory systems, strengthen institutional cooperation, and build regulatory capacity. We also launched the inaugural African National Regulatory Authorities Heads Forum under the African Medicines Agency (AMA) and signed a two-year agreement with GSK Egypt focused on pharmacist training and professional development.
These partnerships serve different purposes. With countries whose regulatory systems are equivalent to ours, we apply mutual recognition, allowing each side to rely on the other’s regulatory decisions. This reduces registration timelines from two to three years to a much shorter process.
For countries with developing regulatory systems, Egyptian approvals are recognized, allowing medicines registered in Egypt to reach those markets faster. Ultimately, our goal is to strengthen African regulatory cooperation while expanding Egyptian pharmaceutical exports as a regional alternative to imports from India and China.
BM: Localizing active pharmaceutical ingredient (API) production is central to strengthening Egypt’s pharmaceutical industry. Where has the greatest progress been made, and what challenges remain?
El-Ghamrawy: APIs are the foundation of pharmaceutical manufacturing, but the challenge isn’t producing them—it’s achieving the scale needed to compete globally with producers in India and China.
If Egypt produces more APIs than the domestic market requires, exports become essential to make production commercially viable. That’s why localization and export strategy must go hand in hand.
The EDA is implementing a comprehensive localization strategy. Egypt now has 183 pharmaceutical factories, 138 cosmetics factories, and 214 medical device factories. The Authority is localizing the 50 most strategically important imported APIs while working with the Unified Procurement Authority on 280 inactive raw materials.
Between 2023 and 2025, the EDA supported the localization of 155 APIs used in 234 finished pharmaceutical products, helping optimize imports worth about $691 million. Local manufacturing now covers 92% to 94% of demand for essential and chronic medicines, while the number of biological products available in Egypt has grown from roughly 8,500 to more than 10,000.
BM: Digital transformation has become a key pillar of the EDA’s strategy. How are initiatives such as Track & Trace changing pharmaceutical regulation?
El-Ghamrawy: Digital transformation is one of our top priorities because it is transforming how medicines are monitored and regulated across the supply chain. Alongside expanding the Track & Trace system, the EDA has introduced mandatory electronic Common Technical Document (e-CTD) submissions and is implementing its Regulatory Procedure Management (RPM) system, with full electronic integration targeted for the first quarter of 2028. Together, these initiatives will reduce approval timelines while improving efficiency, transparency, and regulatory consistency.
Egypt has between 80,000 and 86,000 registered pharmacies. Launched in February 2026, the Track & Trace system will be rolled out over three to five years, integrating every pharmacy and pharmaceutical product into a single digital network. We began with imported medicines and will gradually expand to locally manufactured products. The system enables us to track every medicine pack throughout the supply chain—from the manufacturer to the pharmacy—providing real-time visibility into its location and movement.
The pilot phase includes 4,500 pharmacies connected to the EDA’s digital platform through barcode scanners that record transactions in real time. Each medicine pack is assigned a unique digital identity, helping prevent counterfeiting, enable rapid product recalls, and strengthen regulatory oversight across the market.
BM: Looking toward 2030, what will define success for Egypt’s pharmaceutical sector, and what message would you give to international investors considering Egypt?
El-Ghamrawy: Our ambition is to establish Egypt as a trusted regional center for pharmaceutical manufacturing, regulation, and innovation serving Africa and the Middle East.
Most importantly, these reforms are designed to ensure patients have continuous access to safe, effective, and affordable medicines while building a sector that attracts investment and supports sustainable economic growth.
