上海市人民政府办公厅今日印发《上海市全面深化药品医疗器械监管改革促进医药产业高质量发展的若 干措施》的通知，其中提到，强化全生命周期数智监管。建设数字化监管平台，完善品种和信用档案， 强化创新产业地图、AI+智慧辅助审评审批、AI+现场监管、风险预警等在监管中的应用。深化医疗器 械唯一标识应用，加强与医疗、医保等衔接，逐步扩大品种范围。持续推动中药饮片全程追溯，推进中 药代煎配送等服务数智化建设。 ...

上海市人民政府办公厅今日印发《上海市全面深化药品医疗器械监管改革促进医药产业高质量发展的若 干措施》的通知，其中提到，强化标准引领。积极参与药品医疗器械国家标准制修订和国际标准协调。 发挥新型标准化技术组织作用，推进人工智能医疗器械、医用机器人、脑机接口、粒子治疗设备、创新 中医诊疗设备、细胞与基因治疗等前沿技术的标准化研究。持续开展中药饮片、中药配方颗粒及中医医 疗器械标准研究，依托国际标准化组织/中医药技术委员会（ISO/TC249）等国际标准化平台，制定中医 药国际标准。支持药品医疗器械生产过程数字化追溯等团体标准制订。 ...

Core Viewpoint - Zhejiang Province has launched 20 specific reform measures to enhance the quality of the pharmaceutical and medical device industry, aiming for high-quality development through comprehensive regulatory reforms [1][5]. Group 1: Reform Measures - The implementation plan focuses on five key areas to enhance innovation capabilities, including strengthening the "three medical" collaborative mechanism and improving intellectual property protection [1]. - Zhejiang will optimize the review and approval process for drug changes and implement a "research-review linkage" for medical devices, reducing the review time for major changes to within 60 working days [2]. - A key product list will be compiled to provide comprehensive communication and guidance services for products in critical areas such as cancer and cardiovascular diseases, as well as for urgently needed and rare disease medications [3]. Group 2: Regulatory Capacity Building - The province will advance the research and application of new regulatory tools, standards, and methods, including evaluating the maturity of artificial intelligence medical device algorithms [3]. - The plan aims to enhance the overall safety level and innovation capabilities of drug regulation in Zhejiang, targeting international advanced standards by 2035 [1]. Group 3: Broader Implications - The reforms are expected to significantly promote the high-quality development of Zhejiang's pharmaceutical industry and provide a model for national regulatory reforms in the pharmaceutical and medical device sectors [5].

Core Viewpoint - The establishment of the Beijing-Tianjin-Hebei (Jing-Jin-Ji) Center for Drug and Medical Device Review and Inspection aims to enhance the quality and efficiency of drug and medical device regulation, promoting high-quality development in the pharmaceutical industry across the region [1][2]. Group 1: Overview of the Jing-Jin-Ji Center - The Jing-Jin-Ji Center was inaugurated on September 21 and will serve Beijing, Tianjin, Hebei, and Shandong, leveraging three major centers and four service stations to create a comprehensive service network for the biopharmaceutical industry [1][2]. - The center will provide technical services including research and development guidance, consultation, and review communication, focusing on accelerating the review and approval processes for urgently needed innovative drugs and medical devices [2][3]. Group 2: Services and Support for Enterprises - The Jing-Jin-Ji Center will establish flexible communication channels with enterprises to address uncertainties in drug development, offering in-depth discussions on key technical issues to streamline processes and enhance efficiency [3][4]. - The center will implement an annual training plan based on regional industry needs, providing targeted courses to meet diverse training demands [3][4]. Group 3: Integration and Standardization - The center's operations will be integrated into the unified work system of the National Medical Products Administration (NMPA), promoting standardized drug inspection and resource mutual recognition across the four regions [3][7]. - The establishment of the center is expected to enhance the quality of application materials and optimize the allocation of review resources, with over 1,200 enterprises served and more than 3,000 consultation issues resolved by 2025 [6][7]. Group 4: Strategic Collaboration and Future Goals - The Beijing government will strengthen strategic cooperation with the NMPA to create an efficient regional drug and medical device review system, positioning the Jing-Jin-Ji Center as a platform for high-quality integrated development and innovation in the pharmaceutical industry [7][8]. - The center aims to facilitate the integration of research, production, and clinical resources across the Jing-Jin-Ji and Shandong regions, aligning product development with clinical needs and regional health demands [7].

Core Points - The article discusses the implementation of the "Several Measures for Deepening Drug and Medical Device Regulation Reform in Shanxi Province" aimed at promoting high-quality development in the pharmaceutical industry [1][2] Group 1: Support for R&D Innovation - The measures include six specific actions to support drug and medical device R&D innovation, such as strengthening core technology research, accelerating drug development to preclinical research, and encouraging the innovation and industrialization of drugs and devices [1] Group 2: Improvement of Review and Approval Efficiency - Seven specific actions are proposed to enhance the quality and efficiency of drug and medical device review and approval processes, including optimizing review mechanisms and expediting the approval of urgently needed drugs and devices [1][2] Group 3: Promotion of Innovative Product Application - Four specific actions are outlined to accelerate the application and promotion of innovative products, such as encouraging enterprises to increase the application of innovative results and optimizing support for imports and exports [1] Group 4: Regulatory Compliance Enhancement - The measures emphasize strict regulatory responsibilities and propose seven specific actions to improve compliance levels in the pharmaceutical industry, including promoting the quality enhancement of generic drugs and increasing the efficiency of supervision and inspection [2] Group 5: Development of a Regulatory System - Four specific actions are suggested to build a regulatory system that aligns with industry development and safety needs, such as strengthening regulatory capacity building and advancing regulatory information technology [2]

Core Points - The provincial government is implementing reforms to accelerate the approval process for innovative medical devices and drugs, including establishing a green channel for priority reviews and compressing inspection timelines to enhance market access [1][2] Group 1: Approval Process Optimization - The provincial drug regulatory authority has introduced measures to optimize the review and approval mechanism, including a proactive approach with tailored strategies for each product and dedicated support teams [1] - The approval process for drug changes has been streamlined, reducing the minimum processing time for site changes from 195 days to 105 days, achieving an overall time reduction of over 40% [1] Group 2: Inspection and Registration Improvements - The registration inspection for low-risk drug varieties has been optimized, with the required batch quantity for inspection reduced from three times to two times the full inspection quantity [2] - The inspection timeline for registered medical devices has been compressed to 20 working days, and emergency approvals are being implemented to expedite the process for urgently needed medical devices and drugs [2] Group 3: Focus on Rare Diseases and Urgent Needs - The approval process for drugs and medical devices related to rare diseases has been expedited, with the number of required inspection batches reduced from three to one, and the batch quantity requirement also decreased [2] - Clinical urgent medical devices are prioritized in the approval process, with the approval timeline reduced from 58 working days to 30 working days [2]

Core Viewpoint - Shanxi Province is implementing a series of 28 specific measures to enhance the regulation and development of the pharmaceutical and medical device industry, aiming for high-quality growth in the sector [1][2]. Group 1: Support for R&D Innovation - The measures emphasize strengthening key core technology breakthroughs, accelerating the transition of drug research to clinical trials, encouraging the development and industrialization of innovative drugs and devices, promoting traditional Chinese medicine innovation, enhancing standard leadership, and strengthening intellectual property protection [1]. Group 2: Improvement of Review and Approval Efficiency - The measures include optimizing the review and approval mechanisms, expediting the approval of urgently needed drugs and medical devices, improving clinical trial review processes, enhancing service efficiency in approvals, optimizing registration inspections, accelerating the review of drugs and devices for rare diseases, and advancing the implementation of internationally accepted regulatory rules [2]. Group 3: Promotion of Innovative Product Application - The measures encourage enterprises to increase the application of innovative results, expedite the use of innovative drugs and medical devices in hospitals, enhance medical insurance payments, and optimize import and export support [2]. Group 4: Enhancing Compliance through Effective Regulation - The measures stress the importance of strict regulatory responsibilities, integrating regulation with service, and ensuring high-level safety to support high-quality development, including promoting the authorization of biological product batch release and improving the quality of generic drugs [2]. Group 5: Building a Regulatory System Aligned with Industry Needs - The measures propose to improve the drug safety responsibility system, enhance regulatory capacity building, strengthen regulatory scientific research, and advance regulatory information technology construction [2]. Implementation Timeline - The measures will take effect on June 16, with a commitment to deepen pharmaceutical regulation reforms and support high-quality development in the industry [2].