* Implementation of more than 7,200 licensing procedures for pharmacies, drug stores, and storage outlets
* Issuance of 49,860 professional and administrative certificates for pharmacists during 2025
* Approval of more than 2,700 procedures in the Importers Register and endorsement of 1,678 importation plans
* Handling of 5,364 complaints and inquiries with transparency and rapid response

The Egyptian Drug Authority (EDA) achieved notable progress in the field of licensing pharmaceutical establishments during 2025, as part of its efforts to support the regulatory and supervisory framework, facilitate licensing procedures, and enhance the quality of services provided to the pharmaceutical sector and its various stakeholders.

Regarding the activities of the General Administration of Factory Licensing, a total of 362 technical inspections were conducted for pharmaceutical and medical device manufacturing facilities to grant or update technical operating licenses for factories under the Authority’s jurisdiction. These inspections ensure compliance with Good Manufacturing Practices (GMP) requirements, in cooperation with the General Authority for Industrial Development, in accordance with Law No. 15 of 2017 on facilitating industrial licensing procedures, its executive regulations, and the relevant ministerial decisions governing operations.

These efforts resulted in the issuance of 64 new technical operating licenses for newly established factories, in addition to the update of 307 technical operating licenses for previously licensed factories and plasma collection centers. The newly issued licenses included one license for a raw materials factory, one for a biological raw materials factory, two licenses for human, biological, herbal, and veterinary pharmaceutical manufacturing facilities, three licenses for plasma collection centers, eleven licenses for cosmetics and disinfectants factories, and forty-six licenses for medical device and laboratory reagents factories.

Meanwhile, the updated licenses included 172 licenses for pharmaceutical manufacturing facilities of various types, 17 licenses for plasma collection centers, 71 licenses for cosmetics and disinfectants factories, and 47 licenses for medical device and laboratory reagent factories.

As part of supporting industrial investment, the General Administration of Factory Licensing continues to provide the engineering drawing review service through specialized committees that act as non-binding advisory committees. These committees review engineering designs for new factories or for licensed factories seeking to develop their production or storage areas, ensuring compliance with GMP and Good Storage Practices (GSP) requirements. This contributes to saving time and costs while ensuring product quality. The decision governing the engineering drawing review committee was amended to divide it into specialized committees, including a dedicated committee for medical device factories, pursuant to EDA Chairman Decision No. 818 of 2025.

During 2025, 45 committee meetings were held to review 118 engineering drawings for factories producing human, biological, herbal, and veterinary pharmaceutical products. Additionally, 36 committee meetings were held to review engineering drawings related to medical device and laboratory reagent factories, and 38 committee meetings were convened to review drawings for cosmetics factories, ensuring compliance with GMP and good storage requirements prior to implementation or development.

At the level of pharmaceutical establishment licensing, the Central Administration, in cooperation with inspectors from the Authority’s branches across governorates, issued 2,343 new licenses for public and private pharmacies and their affiliated storage outlets, 2,700 ownership transfer licenses, 784 replacement licenses for lost or damaged licenses, 793 engineering drawing amendment licenses, and 193 licenses reflecting approved data amendments.

Additionally, 15 drug warehouses were licensed, 396 warehouse licenses were renewed, 6 storage outlets affiliated with drug warehouses were licensed, and 28 licenses for such outlets were renewed.

With regard to the General Administration for Licensing Scientific Offices, Drug Warehouses, Intermediary Depots, Stability Centers, and Bioequivalence Centers, 21 new intermediary depot licenses were issued and 74 licenses were renewed, along with 4 new licenses for storage outlets affiliated with intermediary depots and 2 license renewals.

Furthermore, 4 new scientific office licenses were issued, 58 licenses for main and branch scientific offices were renewed, 2 new stability center licenses were issued with 7 renewals, and 1 new bioequivalence center license was issued along with 11 renewals.

Additionally, 4 companies were registered under licensing procedures for pharmaceutical waste transportation, 2 companies for pharmaceutical waste treatment, and 1 technology approval was issued for an environmental services company.

Regarding certificates issued to pharmacists, in cooperation with the Authority’s branches in the governorates, 41,934 certificates for the appointment of pharmacy managers were issued for pharmaceutical establishments, along with 3,005 certificates for opening new pharmacies, 2,828 pharmacy ownership transfer certificates, 226 renewals of new pharmacy opening certificates, 880 renewals of pharmacy ownership transfer certificates, in addition to 640 administrative certificates and 347 experience certificates.

During 2025, the Authority also launched its Electronic Services Platform, through which several licensing services are made available to pharmacists. These include licensing a new pharmacy, registering or withdrawing a pharmacy manager for a community pharmacy, issuing community pharmacy license certificates, and issuing administrative certificates, available across all Authority branches nationwide. This initiative supports digital transformation, simplifies procedures, accelerates service delivery, and enhances communication with stakeholders.
https://serviceportal.edaegypt.gov.eg

With regard to the Importers Register Licensing Department, 304 new registration licenses were issued, 314 re-registration licenses, and 2,099 registration renewals, in addition to approving 1,678 pharmaceutical importation plans. The Licensing Department for Contract Manufacturing Companies also issued 86 new licenses, renewed and updated 341 licenses, and issued 228 license addenda for contract manufacturing companies.

In terms of complaints and inquiries, the Complaints Unit of the Central Administration, in cooperation with the relevant general administrations, handled 455 complaints received through various channels, which were reviewed and responded to accordingly. Additionally, 4,909 inquiries from stakeholders were addressed, reflecting the Authority’s commitment to strengthening communication channels, ensuring prompt response, and continuing to enhance performance and service quality for the pharmaceutical sector.