18条“硬核”举措助推江苏生物医药产业“高质量”

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记者 许海燕 洪叶

10月9日,省市场监管局、省药监局、省知识产权局三部门联合召开新闻通气会,对日前三部门出台的《关于深化改革创新推动生物医药产业高质量发展的意见》进行解读。

《意见》从激发产业创新活力、加速上市审评审批、促进医药产业质量提升、强化技术支撑能力建设、完善服务发展工作机制五个方面提出18条“硬核”举措。

《意见》鼓励创新贯彻药品医疗器械全生命周期管理各个环节。在鼓励研发方面,提出建立创新项目“一站式”服务机制、支持创新平台建设、鼓励开展真实世界数据研究等。在知识产权保护方面,提出促进医药知识产权创造和储备,加快培育布局一批支撑和引领产业发展的高价值专利。在审评审批方面,出台创新医疗器械特别审查程序,对创新器械实行优先检测、优先审评、优先检查、优先审批等。在技术支撑方面,建立省级创新发展服务平台,创新检查员管理机制和检查模式,促进创新产品尽快上市。

围绕破解影响产业发展的瓶颈,《意见》提出一系列举措,如简化产品本地化转移申报资料,加快项目转移进程;对本省生产场地转移类许可申请优先审评审批,确保产品快速达产;申报时可提供自检报告,缓解检验压力。为满足地方医药产业发展需求,《意见》提出建立“面对面”对接服务机制、重点医药产业园区挂钩服务机制、完善知识产权保护和服务机制,加强省市对接联动。

生物医药产业是高度依赖知识产权保护的战略性产业。省知识产权局产业促进处处长丁岚介绍,未来,省知识产权局将着力打造一批支撑产业创新发展的高价值专利培育载体,加快产业关键核心技术攻关和专利布局,抢占制高点,提升竞争力;组建产业知识产权联盟、产业知识产权运营中心,推动知识产权成果走出“实验室”、走上“生产线”、实现“高价值”,跑出产业创新发展的“加速度”;建立一支直接面向企业的“知识产权管家”队伍,开展“面对面”服务,及时解决企业知识产权难题,为产业高质量发展提供服务支撑。

瞄准“产品质量”,《意见》出台了多条举措,其中“实施药品上市许可持有人、医疗器械注册人生产质量安全责任清单”,属于全国首创。省药监局副局长姜伟介绍,我省将实施高质量监管,构建分级分类监管为重点、智慧监管为支撑、信用监管为基础的“三位一体”监管新模式。针对新业态、新模式,推行柔性监管、包容审慎监管,不断强化公平竞争,加强反垄断执法,营造健康有序的发展环境。

激发医药企业创新活力,离不开公平竞争的市场环境。省市场监管局反垄断处处长朱益俊介绍,将持续深化反垄断执法,依法查处医药行业固定商品价格、分割市场、指定交易、附加不合理交易条件等垄断行为,维护医药领域市场竞争秩序;指导医药企业建立反垄断合规体系,提升企业合规水平,引导企业守法经营,防范化解垄断风险。

近年来,我省生物医药产业持续快速发展,医疗器械产品注册存量稳步增长,共有二类医疗器械注册证累计11764件,全国领先。

“我们会进一步加大对医疗器械创新发展的支持力度,做好优先、提速、融合的文章。”省药监局行政审批处处长张霓介绍,“优先”是指对产品具有技术创新领先优势、具有重大临床价值的医疗器械、列入国家重点研发计划、科技重大专项以及对突发公共卫生事件应急所需的第二类医疗器械,实现优先检验、优先受理、优先审评、优先审批,加快产品上市进程。“提速”即针对我省第二类医疗器械审评审批制度机制、工作流程等方面,在减材料、压时限和提效率方面求实效,逐步实现申报材料“应压尽压”、核查程序“应简尽简”、时限“应缩尽缩”。“融合”是将科技创新资源和我省医疗器械产业链发展优势更好融合,握指成拳,助推医疗器械产业链稳定性、安全性和竞争力不断提升。


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