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上海自贸区监管创新:高风险生物样品进口从“畏途”变“坦途”

2017-09-13 15:21:28   新华网

新华社上海9月13日电(记者吴宇)近日,400个包括人体血清、人体组织在内的生物样品从美国伊利诺伊冷藏空运至中国(上海)自由贸易试验区,这是今年七月国家质检总局对相关进口企业进行整体风险评估后,上海自贸区进口的首批高风险生物样品。

上海出入境检验检疫局卫生检疫监管处负责人张琳介绍说,对相关进口企业进行整体风险评估,意味着作为生物样品需求方的国内众多医院和医药科研机构,今后不需各自耗费人力和时间向各入境口岸逐批申报、审批和清关,而可直接通过专业代理企业通过上海自贸区集中进口和清关,且不需要每进一批生物样品都经过长时间风险评估。多年来困难重重的高风险生物样品进口业务,终于从“畏途”变为“坦途”。

经测算,对相关进口企业进行整体风险评估的监管新规实施后,相关生物样品从美国发出至中国用户手中,仅需两周时间,不到以往各自申报进口通关周期的三分之一。预计明年上海自贸区相关企业生物样品进口规模,将从近三年平均每年近千个猛增至9000个左右。

据张琳介绍,鉴于人体血清、人体组织等生物样品含有潜在的传染病风险,属于高风险特殊物品,检验检疫部门在对负责上海自贸区生物样品进口的企业进行整体风险评估过程中,要求其对每一批进口全程记录,做到产品流向实时可查询、可追踪。上海出入境检验检疫局可对相关进口生物样品随机抽样检测,并可与相关属地检验检疫局合作,保障进口生物样品在上海之外地区的后续监管。

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