### Recognition and Accreditation of Biobanks: A Fundamental Step for Scientific Research
The mutual recognition of accredited biobanks among accreditation bodies marks an important evolution in the biobanking landscape, fostering increasing global trust in the competence of these institutions. Recently, a research biobank obtained its second national accreditation, representing a significant milestone for the sector.
Last May, the General Assembly of an important European organization officially recognized the EN ISO 20387 standard as a harmonized tool for the accreditation of biobanks. This standard, now published in Italy as UNI CEI EN ISO 20387:2024, establishes the requirements for competence and impartiality that biobanks must comply with in order to collect, store, and manage biological material and related clinical data in an organized manner, aiming to promote scientific research and development.
The biobanking sector is expected to expand significantly, and according to recent estimates, it is projected to contribute 2.7% to the global Gross Domestic Product by 2030. European institutions have begun to issue accreditations in this emerging sector. In Italy, which is closely monitored to ensure high standards, two biobanks have already been accredited.
### The Importance of Harmonization of ISO 20387
The accreditation of ISO 20387 as a harmonized standard not only increases confidence in biobanking within the European Union but also on a global scale. This standard harmonization is crucial for a sector that is inherently international in nature. The European organization has initiated a process that will culminate in the establishment of a new international mutual recognition agreement for biobanking, allowing for the biological material exchanges and the competence of accredited biobanks to be recognized in all countries that are part of the accreditation network.
These international mutual recognition agreements ensure the equivalence of accreditations, thereby facilitating the circulation of certified goods and services in international markets. Peer evaluations are fundamental, as they represent a guarantee of competence, procedural rigor, and operational uniformity among accreditation bodies worldwide.
### The Second Accredited Biobank in Italy
An Italian research biobank has recently received accreditation, thus becoming the second facility of its kind to achieve this recognition. This development is extremely relevant, not only for the institution itself but also for the national context of biomedical research, as it helps to enhance the quality of research and promote new biotechnologies.
The quality and reliability of biological samples are essential at every stage, from collection to distribution. Each step of the process must be managed in a traceable manner and in accordance with standards to ensure reliable results. Biobanks can therefore ensure the comparability and reproducibility of results in research only through the adoption of standard procedures and the monitoring of associated clinical data.
### The Value of Accreditation for Biobanks
Operating in accordance with the ISO 20387 standard allows biobanks to demonstrate their operational capability and the adequacy of their facilities in terms of competence and impartiality. This regulation covers various essential aspects, from the collection to the storage and distribution of biological material, as well as supporting processes such as quality management systems.
Adhering to such requirements represents a significant guarantee for research, fostering positive impacts not only in personalized medicine and diagnostics but also in the development of new drugs. The evident link to reliable research also translates into a reduced impact on public healthcare spending, making biobanking an increasingly relevant sector.
Therefore, the accreditation of biobanks is not just a recognition of operational capacities but a key element for the future of research and public health. We encourage readers to follow our updates on social media profiles.
