The Egyptian Drug Authority (EDA) has confirmed a major leap in securing Egypt’s medicine supply chain. Starting November 1, 2025, all manufacturers, warehouses, and pharmacies will be required to comply with pharmaceutical traceability regulations.
The exact legal framework will be published in the Official Gazette in the coming days, with a phased rollout expected to take 3–5 years. While this sounds new, the groundwork for Egypt’s track-and-trace system has actually been in development for years dating back to the 2019 EPTTS Implementation Guideline.
Egypt’s track-and-trace journey began well before this latest announcement:
The 2019 guideline was essentially the blueprint detailing how medicines should be serialized, labelled, and recorded in the EPTTS database. However, participation was largely limited to early adopters and pilot participants.
The November 2025 mandate transforms what was once a pilot framework into law-backed, nationwide enforcement:
|
2019 EPTTS Guideline |
2025 Nationwide Mandate |
|
Voluntary or pilot-based participation |
Mandatory for all manufacturers, warehouses, and pharmacies |
|
Focus on technical setup & pilot testing |
Legal enforcement with penalties for non-compliance |
|
Reference document for standards |
Official Gazette publication with binding requirements |
|
Limited rollout |
3–5 year phased national rollout |
In short: The 2019 document tells you how the system works; the 2025 law tells you that you must do it.
Even before the Official Gazette publishes the final details, stakeholders should take action:
With a phased rollout over 3–5 years, the EDA aims to bring every participant in Egypt’s pharma supply chain into the traceability system while giving the industry time to adapt.
For those who have been following the EPTTS since 2019, the new rules will feel like the final stage in a long-anticipated journey. For others, this will be the first time serialization and supply chain transparency become day-to-day operational requirements.
Bottom line
Egypt’s pharmaceutical traceability system is no longer just a technical project, it’s a national policy. The 2019 EPTTS guideline remains a critical reference, but as of November 1, 2025, compliance moves from “good practice” to legal obligation. The sooner companies prepare, the smoother the transition will be.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the Egypt pharmaceutical serialization requirements.
Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.