•A new milestone added to the Authority’s record of international accreditations, placing its laboratories on the World Health Organization’s list of prequalified laboratories.
•The achievement strengthens the EDA’s regulatory and technical capabilities and supports Egypt’s position as a regional center of pharmaceutical excellence.
•The prequalification opens new avenues for cooperation with the World Health Organization and participation in international pharmaceutical quality-monitoring projects.
•International recognition of Egyptian expertise, quality systems, testing accuracy, and compliance with the latest laboratory standards.
In a new international achievement added to the record of the Egyptian Drug Authority (EDA), reflecting its advanced technical capabilities and quality systems aligned with the latest international standards, the EDA’s Pharmaceutical Quality Control Laboratories have been included on the World Health Organization’s (WHO) list of Prequalified Quality Control Laboratories. This makes them the first regulatory laboratories to obtain this international recognition, marking a significant step toward strengthening Egypt’s regional and international standing in the field of pharmaceutical quality and safety assurance.
This achievement comes as a culmination of the Egyptian Drug Authority’s continuous efforts to enhance the performance of its regulatory laboratories, develop their quality management systems, and strengthen their technical capabilities in accordance with the highest international standards and requirements adopted by the World Health Organization. It further reinforces the Authority’s position as an advanced, internationally recognized pharmaceutical regulatory authority and qualifies it to participate in a number of WHO projects and activities, including WHO Prequalification Monitoring Projects, which enable the Authority to assess and analyze the quality of medical products procured and supplied globally through United Nations agencies.
The inclusion of the laboratories on the international list also contributes to strengthening the regulatory oversight system for pharmaceutical products and enhancing public health protection, while reinforcing confidence in the quality and safety of pharmaceutical products. In addition, it supports the competitiveness of the national pharmaceutical industry and opens new avenues for technical cooperation and the exchange of expertise with specialized international laboratories and organizations, further supporting Egypt’s efforts to establish itself as a regional center of excellence in pharmaceutical quality and safety assurance.
This international recognition represents a significant milestone that further establishes the EDA’s regulatory laboratories on the map of internationally qualified laboratories. It also opens the door for their participation in the analysis and assessment of medical products involved in international tenders and procurement programs implemented by international organizations and entities, thereby enhancing opportunities for international cooperation and strengthening the Authority’s role as a trusted provider of analytical services at both the regional and international levels.
The Egyptian Drug Authority’s laboratories obtained this international recognition after fulfilling a comprehensive set of stringent technical and regulatory requirements established by the World Health Organization. These included an extensive review of documents, policies, and testing records, as well as an assessment of the quality management systems and their implementation, along with the procedures followed within the laboratories. WHO inspectors commended the high level of technical competence of the Egyptian personnel and their ability to conduct tests and analyses with a high degree of scientific rigor and accuracy.
This achievement reaffirms the Egyptian Drug Authority’s commitment to continuously developing its regulatory and technical capabilities and strengthening its position at the regional and international levels, in support of its mission to ensure the quality, safety, and efficacy of pharmaceutical products and protect the health of Egyptian citizens.