In a historic milestone for Egypt’s national quality infrastructure, the Egyptian Accreditation Council (EGAC) announced the granting of the first official accreditation for a biobank in Egypt, the Middle East, and Africa. The accreditation was awarded to the Biobank of Theodor Bilharz Research Institute (TBRI) in accordance with the requirements of the international standard ISO 20387:2018 for Biobanking.

This achievement marks the successful completion— for the first time in Egypt— of accreditation procedures in the field of biobanking activities. With this addition, biobanking becomes the thirteenth accreditation field operated by EGAC, reflecting the Council’s continuous expansion and reinforcing its position regionally and internationally as one of the largest accreditation bodies worldwide in terms of scope diversity.

The accredited scope granted to TBRI’s biobank covers the acquisition, processing, long-term preservation, and distribution of human biological materials, including human serum, plasma, and buffy coat, in addition to the management of associated data and information. All activities are conducted in full compliance with ISO 20387:2018, the internationally recognized standard that establishes the general requirements for competence, impartiality, and consistent operation of biobanks, ensuring traceability, integrity, and quality of biological materials used in research and advanced medical applications.

The accreditation became effective on 5 February 2026 for a full four-year accreditation cycle, following the successful completion of comprehensive assessment procedures conducted by an EGAC specialized evaluation team. The assessment included detailed technical evaluations, documentation review, on-site visits, verification of quality management system implementation, validation of sample handling and preservation protocols, and confirmation of compliance with all relevant international requirements.

This milestone represents a strategic advancement in strengthening Egypt’s scientific research infrastructure, particularly in the fields of precision medicine, personalized medicine, genomics, and liver disease research. Accredited biobanks play a fundamental role in ensuring the availability of high-quality, well-characterized, and traceable biological samples, thereby enhancing the credibility, reproducibility, and international acceptance of research outcomes.

The accreditation also comes at a pivotal time as EGAC is progressing toward obtaining international recognition in the field of biobank accreditation from the European co-operation for Accreditation (EA) in 2026. Such recognition will further enhance the global credibility of EGAC’s accreditation services in this specialized field and open broader opportunities for international scientific collaboration and research partnerships.

EGAC affirms that accrediting the Biobank of Theodor Bilharz Research Institute reflects the effective integration between research institutions and the national quality infrastructure. It underscores Egypt’s commitment to implementing the highest international standards in managing scientific and biological resources, thereby strengthening confidence in Egyptian research outputs and enhancing their competitiveness at both regional and global levels.

The Egyptian Accreditation Council will continue its strategic efforts to expand and develop emerging accreditation fields in line with global scientific and technological advancements, in support of Egypt’s vision toward a knowledge-based and innovation-driven economy.