推进苏州生物医药产业发展的特殊物品卫生检疫措施研究

Analysis of Quarantine Measures for Special Products for the Development of Biomedical Industry in Suzhou

为推进苏州生物医药产业高质量发展,通过文献检索、专家咨询、访谈和问卷调查等多种方式,对苏州生物医药产业现状、与生物医药产业相关的特殊物品监管方面的不足进行分析。企业对出入境特殊物品监管诉求集中在通关便利化、合理精准科学分类、精细化风险评估和完善查验程序等方面。在特殊物品的监管中,主要存在以下问题:生物安全立法理念尚未完全得到落实、监管部门和环节点多、监管整体能力需要进一步提升、口岸通关时间难以精准控制、后续监管形式化和行业管理分段化、特殊物品卫生检疫专业人员相对少和检测要求高、对涉及特殊物品的违法违规行为处罚力度不够等。在此基础上,立足苏州在全国生物医药产业的定位,提出了强化特殊物品卫生检疫顶层设计、完善特殊物品审批和风险监测制度、建立特殊物品智慧查验机制、创新开展特殊物品多部门联合监管、加强长三角区域海关一体化合作、加强政策服务和典型违法案例普法,实现对特殊物品卫生检疫措施的针对性改进,切实推进苏州生物医药产业的高质量发展。

To promote the high-quality development of the biomedical industry in Suzhou,an a-nalysis was conducted on the current status of the industry and the deficiencies in the regulation of spe-cial products related to the biomedical industry through methods such as literature search,expert con-sultations,interviews,and questionnaire surveys Businesses’demands for the supervision of special products focus on convenient customs clearance,rational and accurate classification,detailed risk as-sessment,and improved inspection procedures Several issues were identified in the supervision of spe-cial products,including incomplete implementation of biosafety legislation,multiple regulatory authori-ties and procedures,the need for further improvement in overall regulatory capacity,difficulties in pre-cise control of port clearance time,empty formalism of post-clearance control and segmentation of indus-try management,shortage of hygiene and quarantine professionals for special products,and insufficient penalties for violations related to special products Based on these findings,proposals were made to strengthen the top-level design of hygiene and quarantine for special products,improve the approval and risk monitoring system for special products,establish an intelligent inspection mechanism for special products,innovate multi-departmental joint supervision for special products,enhance integrated coop-eration among customs in the Yangtze River Delta region,strengthen policy services,promote public awareness of regulations and typical cases of violations,and effectively improve supervision measures for special products to promote the high-quality development of the biomedical industry in Suzhou.