Medina Plebeian B, Armon Subasri, Bin Abdul Aziz Mohammad Firdaus, Cheong Io Hong, de Leon Marian P, Drobysz Sonia, Fikry Bin Haji Abdul Momin Muhd Haziq, Garcia Debra Leiolani, Iskandriati Diah, Kozlakidis Zisis, Cui Lin, Mao Seanghorn, Miranda Mary Elizabeth, Mya Khin Mar, Nallenthiran Lingeswran, Obusan Marie Christine, Phimmakong Kongchay, Sabai Phyu, Saejung Channada, Sathasivam Hans Prakash, Jafar Faizatul Lela Binti, Vitor Rodel Jonathan S, Yabes Ailyn M, Calaor Alan B, Vijayan Viji, Lin Raymond T P
Department of Health, Research Institute for Tropical Medicine, Manila, Philippines.
Hospital Kuala Lumpur, Ministry of Health, W.P. Kuala Lumpur, Kuala Lumpur, Malaysia.
Biopreserv Biobank. 2025 Jun;23(3):165-176. doi: 10.1089/bio.2024.0044. Epub 2024 Sep 9.
Southeast Asian countries are at the forefront of public health pressures due to a confluence of factors such as population growth, urbanization, environmental pollution, and infectious diseases (re)emergence. Therefore, the ability to be able to conduct research addressing local and regional needs is of paramount importance. As such, biobanking activities, the standardized collection of biological samples, and associated data, developed over the past few decades supporting ongoing biomedical and clinical research, as well as surveillance are of critical importance. However, the regulatory landscape of biobanking is not widely understood and reported, which this narrative review aims to address for the ASEAN member states. It is evident that there are specific regulatory arrangements within each ASEAN member state, which though may be sufficient for the current level of operations, are unlikely to support a regional sharing of biological samples, data, and eventually benefits from the conducted research. Additionally, legacy and often-overlapping regulatory frameworks exist, which raise the need of an eventual consolidation under a single framework. Thus, this field requires further study as well as the creation of viable, practical proposals that would allow for biobanking harmonization and thus the exchange of biological samples and data to be achieved regionally, if not further afield.
由于人口增长、城市化、环境污染和传染病（重新）出现等多种因素的共同作用，东南亚国家处于公共卫生压力的前沿。因此，开展满足当地和区域需求的研究的能力至关重要。因此，过去几十年来发展起来的生物样本库活动、生物样本和相关数据的标准化收集，对正在进行的生物医学和临床研究以及监测至关重要。然而，生物样本库的监管情况并未得到广泛理解和报道，本叙述性综述旨在为东盟成员国解决这一问题。显然，每个东盟成员国都有具体的监管安排，这些安排虽然可能足以满足当前的运营水平，但不太可能支持生物样本、数据的区域共享，以及最终从所开展的研究中受益。此外，存在遗留且往往重叠的监管框架，这就需要最终在一个单一框架下进行整合。因此，这一领域需要进一步研究，并提出可行、实用的建议，以实现生物样本库的协调统一，从而在区域乃至更广泛范围内实现生物样本和数据的交换。
