The Egyptian Drug Authority (EDA) has secured a new international accreditation, adding to its growing record of achievements in the fields of quality assurance and international recognition. The Authority's General Administration of Reference Laboratories has been accredited by the Egyptian Accreditation Council (EGAC) as the first Egyptian producer of Certified Reference Materials (CRMs), in accordance with the requirements of the international standard ISO 17034:2016, which specifies the competence requirements for reference material producers.
The accreditation follows an official assessment visit conducted by a delegation from the Egyptian Accreditation Council (EGAC), during which comprehensive technical and administrative evaluations were performed. These assessments encompassed the operational framework of the reference laboratories and included verification of production, analytical, and quality assurance systems to ensure full compliance with the requirements of ISO 17034:2016.
This achievement underscores the Authority's continued commitment to implementing the highest standards of quality in its technical and regulatory activities through the production of highly characterized reference materials used in regulatory testing and in ensuring the quality, safety, and efficacy of pharmaceutical products and medical devices.
In this context, Dr. Ali El-Ghamrawy, Chairman of the Egyptian Drug Authority, stated that this international accreditation represents a natural extension of the Authority's ongoing development journey. He noted that the Authority has now added another significant accomplishment to its portfolio through its recognition as a producer of Certified Reference Materials, reflecting its readiness to undertake regional and international reference roles in the fields of analysis, regulatory oversight, and quality assurance.
This accreditation constitutes a key milestone within a strategic national initiative aimed at localizing the production of reference materials using domestic resources, thereby supporting the national pharmaceutical industry and reducing dependence on imported products. Furthermore, these materials serve as highly reliable reference tools utilized in the preparation of monographs for the Egyptian Pharmacopoeia and contribute to enhancing the efficiency of development, registration, and analytical activities across the pharmaceutical sector.
The newly obtained international accreditation further demonstrates the Egyptian Drug Authority's commitment to aligning its regulatory practices with the latest international standards and specifications. This achievement strengthens the Authority's position as an internationally recognized regulatory body and contributes to enhancing the competitiveness and global reach of Egyptian pharmaceutical products, particularly in the fields of pharmaceuticals, medical devices, and cosmetic products.
Through this milestone, the Egyptian Drug Authority continues to advance its strategic vision of promoting regulatory excellence, fostering innovation, and supporting the sustainable development of the healthcare and pharmaceutical sectors, while further consolidating Egypt's position as a regional hub for quality assurance and pharmaceutical regulation.