Over the past few months, several important milestones have been announced by the Egyptian Drug Authority (EDA), confirming that the national track & trace system is entering its operational phase.
Here is a consolidated snapshot of where the implementation stands today.
Pilot Phase Has Started
According to reports from Al-Mal Newspaper, the pilot phase of the national system has officially begun.
• The pilot currently covers 6 narcotic product categories
• Around 18,000 serialized pharmaceutical packs are being tracked
• Products are dispensed through Esaf pharmacies as part of a controlled testing environment
Official Launch of the National Project
Dr. Ali El‑Ghamrawy, Chairman of the Egyptian Drug Authority, officially launched the national pharmaceutical track & trace project from an Esaf pharmacy branch in Giza.
Regulatory Framework
In late 2025, Egypt officially announced the implementation of the national system covering:
• Serialization and aggregation requirements
• Imported medicines starting February 2026
• Locally manufactured medicines starting August 2026
Decision 804 defined:
• Mandatory reporting events
• Responsibilities across supply-chain stakeholders
• Clear compliance expectations
The national traceability hub will be powered by technology from SAP.
Controlled Registration of Imported Medicines
To avoid market disruption, the EDA adopted a phased onboarding strategy.
Phase 1
• Started in the second week of February
• Runs for 3 months
• No new imported SKUs added during this phase
Phase 2
• Opens after Phase 1
• Allows new imported products and companies
• Also runs for 3 months
In total, 1,300 imported pharmaceutical products will be gradually onboarded through monthly batches, with completion expected before August.
Local Manufacturing Integration
Parallel to imported products:
• Registration of locally manufactured medicines will start in August
• Products will also be onboarded in monthly batches
This phased approach reflects the complexity of Egypt’s pharmaceutical ecosystem.
Phase 1 Technical Execution (EPTTS)
Phase 1 of the Egyptian Pharmaceutical Track & Trace System (EPTTS) focuses on a controlled onboarding mechanism using CSV-based event reporting.
Current EPCIS business steps supported:
Commissioning of Serialized Trade Items (STIN)
Commissioning of Shipping Container Codes (SCC)
Packing / Aggregation events
Key operational rules include:
• EPC must be commissioned before packing
• Files must be uploaded as a single validated CSV structure
• Maximum 50,000 serialized items per file
• Maximum 5 batches per commissioning file
This approach allows companies to start submitting traceability data even before full system-to-system EPCIS integration becomes mandatory.
Supply Chain Infrastructure in Egypt
The scale of the Egyptian pharmaceutical ecosystem highlights the importance of a phased rollout.
• 4 billion medicine packs sold in 2025 (vs. 3.5B in 2024)
• Market value: USD 8.8B
• ~180 local manufacturers
• ~1,600 pharmaceutical warehouses
• ~80,000 pharmacies
• ~12,000 registered products
Local manufacturing represents 91% of total volume and 70% of market value, while imports represent 9% of volume but 30% of value.
Supporting Market Adoption
The EDA is also preparing incentive programs to accelerate adoption.
Planned initiatives include providing computers and barcode scanners to selected pharmacies to ensure accurate and fast serialization verification during dispensing.
Some notes to the latest decisions
- Pallet’s aggregation not mentioned in Execution requirements for the first phase of EPTTS only shrink and carton for local manufacturing.
- Adding manufacturing date on the outer packaging is mentioned in Execution requirements for the first phase of EPTTS for the first time.
- Other event types (e.g., shipping, receiving, unpacking, returns, dispensing, destruction) are outside the scope of Phase 1