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北京市第四家药品医械创新服务站落户海淀
Bei Jing Qing Nian Bao· 2025-09-26 01:30
本报讯(记者张月朦)昨日,北京药品医疗器械创新服务站(海淀)(以下简称海淀站)正式落户 中关村创业大街,成为继昌平、经开区、大兴之后,本市第四家市级药品医疗器械创新服务站。自此, 全市正式形成"东南西北"协同布局的药品医疗器械创新服务网络。北京青年报记者了解到,海淀站已成 功入围国家自主创新示范区政策试点"揭榜挂帅"单位名单,未来将精准对接海淀区产业优势,为全市医 药健康产业高质量发展搭建专业高效的服务桥梁。 25日上午,北青报记者在海淀站看到,350平方米的空间内功能齐全、服务完备,从容纳四五人的 洽谈室到十几人的会议室,将为企业提供从研发到上市的全链条服务。北京中关村科学城创新发展有限 公司杜劭君介绍,海淀站之所以选址中关村创业大街,是因为这里距离北大、清华、中科院都不远,能 够方便高校实验室的研发成果尽快落地。"除了政策咨询,海淀站还会为企业融资提供服务,中关村科 学城有规模200亿元的母基金,还链接了很多投资机构,有企业来咨询的时候,我们会把后面一整套的 服务都帮着对接上。"杜劭君说。 活动现场还发布了全国首个省级生物医药企业合规指引——《北京市生物医药企业合规指引》,旨 在帮助生物医药企业快速识别当 ...
北京药品医疗器械创新服务站(海淀站)正式揭牌
Bei Jing Shang Bao· 2025-09-25 11:34
Core Insights - The Beijing Drug and Medical Device Innovation Service Station (Haidian Station) was officially inaugurated on September 25, marking the fourth municipal-level innovation service station in Beijing, focusing on "integrated innovation and AI empowerment" [1] - Haidian District is a key area for the pharmaceutical and health industry in Beijing, housing over 700 pharmaceutical health companies, 20 listed companies, and 33 national-level specialized "little giant" enterprises, supported by rich clinical and research resources [1] - The Beijing Municipal Drug Administration has introduced innovative regulatory measures to support high-quality development in the pharmaceutical sector, with significant progress on multiple initiatives [2] Regulatory Innovations - The Beijing Municipal Drug Administration has implemented a project management system for key projects, with 324 products currently under management, leading to the approval of 20 innovative drugs and medical devices this year [2] - The efficiency of drug and medical device review and approval processes has improved, with over 95% of services available online, making it a national leader in this area [2] - The inspection capabilities for medical devices have been enhanced, achieving a 20% reduction in inspection cycles for urgently needed clinical products, with the fastest inspection speed for antibody drugs in the country [2] Compliance Guidance - The launch of the "Beijing Biopharmaceutical Enterprise Compliance Guidelines" aims to help biopharmaceutical companies identify compliance risks and establish effective risk management systems [3] - A city-wide initiative called "Legal Protection for Innovative Pharmaceutical Enterprises" will provide compliance training and support for companies, focusing on legal interpretation, risk identification, and compliance system development [3] - The Beijing Municipal Drug Administration plans to enhance its service network and prioritize innovative product approvals, aiming for a continued lead in the approval of innovative medical devices and AI medical devices by 2026 [3]