Xiang Cheng, Zhu Qing, Wen Jinqing, Xie Lixiang, Hao Rongrong, Qiu Xueting, Zhu Fei
Zhejiang Provincial Center for Medical Science Technology & Education Development, Hangzhou, Zhejiang, China.
PLoS One. 2025 Aug 12;20(8):e0328923. doi: 10.1371/journal.pone.0328923. eCollection 2025.
Policies play a pivotal role in guiding and overseeing laboratory biosafety management. To ensure that laboratory biosafety management is underpinned by scientifically robust and well-founded policies, an analysis and evaluation of existing policies were conducted. The object was to identify their merits and limitations, thereby offering references for future policy development. The qualitative and quantitative analysis were employed to explore 137 central-level policies issued in China as of April 30, 2024. Additionally, based on policy evaluation theory, a PMC index model was established to evaluate 11 representative laboratory biosafety policies. The results showed that: Firstly, these policies, promulgated by 24 distinct departments, spanned three regulatory tiers: laws, regulations, and administrative rules. Secondly, content analysis revealed three primary aspects: (1) management systems, (2) facility, equipment and containment barrier, and (3) operational technical standards. Thirdly, the average PMC index of the 11 policies was 5.05. Specifically, two policies were deemed excellent, eight policies were acceptable and one was inadequate. The low score was mainly attributed to three indicators: policy level, policy timeliness, and policy content. To sum up, laboratory biosafety policies in China were generally rational and comprehensive. However, insufficient collaboration among departments during policy formulation, as well as the need to improve policy continuity were identified. To enhance biosafety laboratory management, four recommendations are proposed: 1. Strengthen communication among different departments; 2.Optimize the policy formulation process; 3. Enhance supervision of biosafety level 1 and 2 (BSL-1/2) laboratories; 4. Harnessing the power of industry associations.
政策在指导和监督实验室生物安全管理方面发挥着关键作用。为确保实验室生物安全管理有科学稳健且有充分依据的政策支撑，对现有政策进行了分析和评估。目的是找出其优点和局限性，从而为未来政策制定提供参考。采用定性和定量分析方法，对截至2024年4月30日中国发布的137项中央级政策进行了研究。此外，基于政策评估理论，建立了PMC指数模型来评估11项具有代表性的实验室生物安全政策。结果表明：首先，这些政策由24个不同部门发布，涵盖法律、法规和行政规章三个监管层级。其次，内容分析揭示了三个主要方面：（1）管理体系，（2）设施、设备和防护屏障，（3）操作技术标准。第三，11项政策的平均PMC指数为5.05。具体而言，两项政策被评为优秀，八项政策可接受，一项政策不足。得分较低主要归因于三个指标：政策层级、政策时效性和政策内容。综上所述，中国实验室生物安全政策总体合理且全面。然而，发现政策制定过程中部门间协作不足，以及政策连续性有待提高。为加强生物安全实验室管理，提出四点建议：1. 加强不同部门间的沟通；2. 优化政策制定流程；3. 加强对一级和二级生物安全实验室（BSL-1/2）的监管；4. 发挥行业协会的作用。
