### Recognition of Accredited Biobanks and Future Perspectives
The mutual recognition of accredited biobanks among accreditation bodies represents a fundamental step towards building global trust in the competence of these facilities. Recently, an important national accreditation was granted to a research biobank. This recognition is part of a broader context in which biobanks are emerging as key players in the biomedical research landscape.
A significant development came from the General Assembly of European co-operation for Accreditation (EA), which validated the EN ISO 20387 standard as a harmonized standard for the accreditation of biobanks. This decision, formalized in EA Resolution 2025 (57) 1, establishes an important standard to ensure that biobanks operate with requirements for competence and impartiality.
The standard, published in Italy as UNI CEI EN ISO 20387:2024 and titled “Biotechnologies – Biobanking – General Requirements for Biobanking,” sets specific criteria for facilities that collect, preserve, and manage biological material and related clinical data for research and development purposes.
## A Growing Sector
The biobanking sector is rapidly evolving, with projections indicating a structural impact on the global economy, expected to reach 2.7% of global GDP by 2030 according to OECD estimates. This scenario encourages European accreditation bodies to begin issuing accreditations, with our country already having accredited two organizations.
The recognition of ISO 20387 as a harmonized standard fosters trust in biobanks not only in Europe but globally. This is crucial for such an international sector, whose implications extend well beyond national borders.
Furthermore, EA has initiated the process to implement the new EA Multilateral Recognition Agreement (EA MLA) for biobanking, which is based on the peer evaluation of accreditation bodies. This implies that the competencies and biological materials of accredited biobanks will be recognized across all European countries that are part of this network, facilitating the circulation of certified goods and services in global markets.
## Ensuring Quality and Reliability
Peer evaluation checks serve as the best guarantee of the competence and uniformity of procedures among accreditation bodies. In Italy, a significant example is the research biobank that recently received accreditation: it is the second accredited biobank in the country, following a previous structure that was recognized in 2022.
These accreditations not only promote a growth environment but are fundamental for improving research and developing new biotechnologies. It is crucial that every stage of the process, from collection to preservation, and from transport to distribution of biological material, is managed in a traceable manner and in compliance with established requirements.
The adoption of standardized procedures and the monitoring of associated clinical data are essential to ensure the comparability and reproducibility of results.
## The Importance of Accreditation
Operating under the ISO 20387 standard allows accredited biobanks to demonstrate their operational capabilities and the validity of their structure, which must adhere to criteria of competence, impartiality, and operational consistency. The requirements of this standard encompass all aspects related to the management of biological material, including supporting functions such as quality management systems.
Adherence to these requirements is a significant guarantee for research, both academic and industrial, positively influencing the fields of personalized medicine, diagnostics, and the development of new drugs. Moreover, research that generates reliable results contributes to a reduced impact on public healthcare expenditure, making accreditation an added value not only for the facilities but also for the entire healthcare system.
In conclusion, the biobanking landscape is evolving rapidly…
