Importers to be notified of registration schedules early next week
Informed sources at the Egyptian Drug Authority (EDA) revealed that the executive framework for onboarding and registering imported pharmaceutical products into the new track-and-trace system has been finalized. This will be implemented through a dedicated section added to the Authority’s official website, enabling structured and phased submission of data related to these products.
The sources told Al-Mal that the EDA held an expanded meeting last Monday, chaired by Dr. Ali El-Ghamrawy, Head of the Egyptian Drug Authority, with representatives of DAF Digital Solutionsalong with a number of relevant stakeholders, to discuss timelines and implementation mechanisms.
They added that the meeting concluded with assigning one of the EDA’s central department heads, along with Dr. Engy Alaa from DAF Digital Solutions, to prepare a detailed timeline specifying the dates for onboarding products and different therapeutic groups, whether imported or locally manufactured.
According to the sources, the Authority has decided not to register imported products in a single batch. Instead, onboarding will take place gradually in defined phases to ensure market stability and avoid disruption to supply chains.
They noted that the actual start of registration for imported products will be during the second week of next February and will continue for three consecutive months, during which no new products will be added. This will be followed by a second phase in which new batches of imported products and additional importing companies will be onboarded, after which registration will pause again for three months,continuing in an alternating cycle.
The sources expect the full onboarding of all imported therapies, along with a number of local products, into the pharmaceutical track-and-trace system to be completed by the end of September 2026.
Regarding the pilot implementation of the system, the sources revealed that El-Ezaby pharmacy chain and “Al-Somoum” pharmacies will be excluded from the first phase. The launch will be limited to the pharmacies of the Egyptian Company for Trading in Pharmaceuticals (ECTP) only, totaling 57 pharmacies nationwide.
They explained that the first phase will focus on a limited number of imported therapies, in addition to narcotic substances, which are dispensed exclusively through ambulance pharmacies, given their high-risk nature and the need for enhanced regulatory control.
The sources confirmed that ECTP, Pharma Overseas, and Ibn Sina have been selected as the authorized distributors for the first operational phase, ensuring the availability of organized and electronically traceable distribution channels from day one.
They stressed that the Authority will notify importers early next week of the registration schedules and mechanisms, in a manner that ensures smooth procedures without any disruptions.
In the same context, Dr. Tamer El-Husseiny, Vice President of the Egyptian Drug Authority, met yesterday (Tuesday) with a number of distributors to discuss their roles within the track-and-trace system, electronic integration mechanisms, and technical readiness requirements.
The Authority was also scheduled to hold a meeting today (Wednesday) with several manufacturers to discuss in-factory implementation mechanisms, serialization and coding requirements, and compliance plans with the defined timelines. However, the meeting was postponed due to the Authority’s President being abroad.