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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
Core Insights - The establishment of the Haidian Station marks the fourth municipal-level innovation service station for pharmaceuticals and medical devices in Beijing, enhancing the city's collaborative innovation network [1] - Haidian Station aims to provide precise support for pharmaceutical and health enterprises, leveraging the district's strengths in research, healthcare, and AI to accelerate product incubation [1][2] - The station will offer comprehensive services including policy consultation, technical guidance, and expedited approval processes for key projects [1][2] Summary by Sections Establishment and Purpose - Haidian Station is located in Zhongguancun Entrepreneurship Street and is part of a coordinated layout for innovation services across Beijing [1] - The station is recognized as a pilot unit for national independent innovation demonstration zones, aiming to facilitate high-quality development in the pharmaceutical health industry [1] Services Offered - The station provides a full range of services from early-stage research to market launch, including priority review for key projects and a green channel for production licensing [1][2] - It also connects enterprises with a 20 billion yuan mother fund and various investment institutions for financing support [2] Compliance and Training - The launch of the first provincial-level compliance guidelines for biopharmaceutical companies aims to help businesses identify compliance risks and establish effective risk management systems [2] - The station will conduct compliance training sessions to enhance the management capabilities of pharmaceutical enterprises [2] Future Goals - The Beijing Drug Administration plans to enhance the drug supervision service network and focus on prioritizing innovative products for approval [3] - The goal is to lead the nation in the approval of innovative medical devices and AI medical devices by 2026 [3]
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]