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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]