This is a compilation of the recent regulatory updates for Egypt. Every week, we post an update of what's new, which you can view here.
- December 2: The European Commission and Heads of Medicines Agencies held a workshop with stakeholders to agree on common key principles for implementing electronic product information for the European Union (EU). Those principles are being drafted for publication in January of 2019 to gain public commentary.
- November 25: The Ministry of Health announced a workshop on November 22 to discuss the upcoming regulations and current implementation plan submission requirements regarding medical traceability by factories, companies, and parties working in the Egyptian pharmaceutical market.
- November 11: Egypt published an update to their drug track and trace requirements, which document the data and encoding guidelines for individual packs and cases of medicines throughout the supply chain. Along with these guidelines, it was announced that MAHs/manufacturers must submit an initial report and implementation plan to include barcoding and serialization for all medicines and GTINs/GLNs for each company by the end of 2018.
- June 29: The serialization and government reporting requirements for June 2018 have been postponed as long as MAH apply a barcode and identifier to at least one pack and report it to the Ministry of Health by the end of the year. No reset timelines were published.
- April 1: The official track and trace implementation guidelines are finished and will be published this coming week (week of 4/2). Serialization and compliance reporting details will be included with a follow-up on technical guidelines for specific integration requirements to Egypt national system. No announcements will be made on deadlines, but the outcome of the upcoming April stakeholder meeting with the Ministry of Health is expected to result in the serialization deadline of June 2018 sticking and aggregation/compliance reporting being delayed until 2019.
- March 11: Industry guidance on regulations is ready for publication but a circulation date hasn't been set. The XML reporting schema will follow soon after and the June 2018 deadline still stands.
- February 25: A cross-industry stakeholder meeting was held, with some discussion of agreement to delay the June 2018 deadline for serialization and reporting to 2019 given slow progress on publishing guidelines and the start up of the government system. Recommendations may be made to start with high-priority drugs as a pilot.
- January 28: Ministry of Health is drafting serialization and reporting requirements for February publication. They are still expecting full serialization compliance by June 2018.