上海重磅发布 日前，上海市人民政府办公厅印发《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》。 其中提到，聚焦细胞与基因治疗、罕见病、儿童用药、高质量首仿药、人工智能医疗器械、医用机器人、脑机 接口、粒子治疗设备、创新中医诊疗设备等重点领域和产品，建立在研重点品种服务清单，在临床试验、注册 上市、检查检验、生产许可等环节跨前指导。 完善医疗卫生机构伦理协作审查机制，简化统一受理资料和流程、增加会议频次、缩短审查时间，推进长三角 区域多中心临床试验伦理协作审查。加强临床医疗数据标准化，强化数据在研发创新中的运用。建立以临床价 值为导向的创新医疗器械筛选评估机制，加速转化上市。 支持中药研发创新。建立医疗机构规范收集整理人用经验数据机制，探索人用经验数据作为真实世界证据用于 药品注册申报。制订医疗机构应用传统工艺配制中药制剂备案管理规定。支持疗效确切、特色优势明显的医疗 机构中药制剂及名老中医方开发转化为中药新药。鼓励医疗机构、研发单位和药品企业共同打造中药创新与产 业转化平台，支持中药创新药临床研究和古代经典名方中药复方制剂研究，鼓励中药大品种培育和经典品种二 次开发。外省市按照国家药品 ...

Core Viewpoint - The Shanghai Municipal Government has issued measures to deepen the reform of drug and medical device regulation, aiming to promote high-quality development in the pharmaceutical industry, focusing on key areas such as cell and gene therapy, rare diseases, and pediatric medications [1] Group 1: Key Areas of Focus - The measures emphasize the importance of specific fields and products, including cell and gene therapy, rare diseases, pediatric medications, high-quality first generic drugs, artificial intelligence medical devices, medical robots, brain-machine interfaces, particle therapy equipment, and innovative traditional Chinese medicine diagnostic and treatment devices [1] Group 2: Regulatory Support - A service list for key varieties under research will be established, providing proactive guidance in clinical trials, registration and listing, inspections, and production licensing [1]

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 Insights - The approval of innovative medical devices in China has reached a historical high, with 323 devices approved to date, reflecting a significant acceleration in regulatory innovation and support for high-end medical device development [1][2][5] Regulatory Developments - The National Medical Products Administration (NMPA) has implemented special reviews for innovative medical devices that are domestically created, internationally leading, and clinically valuable, aiming to optimize the review process [1][2] - The NMPA plans to enhance the legal and standard framework, increase support for research and development, and improve the efficiency of reviews and approvals [1][2] Industry Trends - The number of approved innovative medical devices has been increasing annually, with a 87.5% year-on-year growth in the first half of 2025 [2] - The domestic medical imaging industry has seen improvements in the supply chain and production capabilities, with many mid-to-low-end products achieving domestic substitution [2][3] Challenges in Domestic Production - Despite advancements, there are still significant challenges in foundational research, software development, and reliance on imported key components [3][4] - The overall market share of domestic high-end medical imaging equipment remains low, indicating ongoing dependency on foreign technology [3][4] Strategic Initiatives - The NMPA has established innovation cooperation platforms for artificial intelligence and biomaterials to facilitate the transformation of research into practical applications [5] - The Ministry of Industry and Information Technology and the NMPA have announced initiatives to focus on key materials and technologies to enhance domestic production capabilities [5] Expert Consultation Mechanism - The NMPA has introduced an expert consultation mechanism to guide innovative medical device companies through the development and approval process, ensuring comprehensive understanding of cutting-edge technologies [7][8] - The expert consultation process includes a diverse pool of approximately 2,500 experts across various medical and technical fields to support the review and evaluation of innovative products [8][9] Focus Areas for Future Development - Future research in artificial intelligence medical devices is expected to concentrate on wireless diagnostics, digital therapies, brain-machine interfaces, and flexible wearable devices [6]

Core Insights - The forum on "Medical Device Technology Review and High-Quality Development" highlighted the rapid growth and innovation in Beijing's medical device industry, with a projected revenue exceeding 1 trillion yuan in 2024 [1][3] - Beijing has established itself as a national innovation hub for the pharmaceutical industry, with over 81 approved Class III innovative medical devices, accounting for more than 20% of the national total [1][3] - The city is leading in the number of artificial intelligence medical products and surgical robots, further solidifying its position in the medical device sector [1][3] Industry Development - The medical device industry is increasingly recognized for its importance in the health sector, with Beijing forming significant advantages through policy support and industry collaboration [3] - As of 2024, the medical device industrial output value is expected to reach 48 billion yuan, with retail and wholesale values at 390 billion yuan [3] - The Beijing Drug Administration has implemented measures to streamline the review and approval process, reducing the average review time for Class II medical devices to 43 working days [3] Innovation and Regulation - The Beijing Economic and Technological Development Area (Yizhuang) is a key area for the development of the medical and health industry, housing over 5,000 enterprises and accounting for nearly half of the city's output [4] - Yizhuang has entered 56 products into the national special review process for innovative medical devices, with 25 approved for market launch [4] - The area aims to create a world-class medical device industry cluster through a dual-driven approach of foreign investment and local ecosystem development [5] Expert Support and Collaboration - The National Medical Products Administration's Medical Device Technical Review Center has over 2,500 experts, including 41 academicians, providing technical support for the review process [6] - A collaborative platform for innovative biomaterials was established to address critical issues in the field, emphasizing the strategic importance of mastering core technologies [7] Clinical Applications - The forum discussed the regulatory focus on specific medical devices, such as orthokeratology lenses, with domestic products accounting for two-thirds of the market [8] - Artificial intelligence medical devices are generating numerous clinical application scenarios, enhancing medical supply capabilities and optimizing treatment processes [9]

Core Insights - The "Results Transformation Forum" focuses on the integration of high-performance medical device technology and innovation, addressing the needs for deep collaboration between industry, academia, and research [1][3] Group 1: Forum Overview - The forum is themed "New Quality Building Dreams, Medical-Engineering Integration" and is organized by the Guangdong Provincial Association for Science and Technology, with eight sub-forums dedicated to academic sharing, paper competitions, industry exhibitions, and collaboration agreements [3] - The forum aims to promote technological and industrial innovation in the high-performance medical device sector, which is crucial for improving disease diagnosis and enhancing public health [3] Group 2: Industry Trends - The global population aged 60 and above is projected to reach one-sixth by 2030 and 2.1 billion by 2050, leading to a more diverse and economically viable demand for medical device services [3] - China's medical device industry has established a comprehensive development ecosystem, with increasing domestic enterprise numbers and enhanced product export capabilities [3] Group 3: Technological Advancements - The development of artificial intelligence (AI) in medical devices is accelerating, with AI technologies accounting for approximately one-third of the approved Class III medical devices in 2024, particularly in medical imaging [4] - Experts emphasize the need for deeper medical-engineering integration to overcome existing bottlenecks in diagnosis and treatment pathways, leveraging AI's rapid advancements for high-end medical device innovation [4]

Core Viewpoint - The article outlines Suzhou's strategic plan to accelerate the development of the "Artificial Intelligence+" city initiative, aiming to establish a robust AI ecosystem by 2026, including significant investments and talent development [1][2][3]. Group 1: Investment and Funding - Suzhou plans to establish an AI fund cluster exceeding 50 billion yuan by 2026 [1]. - The city aims to achieve 50 key core technology breakthroughs and accumulate over 13,000 high-value patents in the AI sector by the end of 2026 [1]. Group 2: Talent Development - By 2026, Suzhou aims to cultivate 240 leading talents in the AI field and establish 15 various talent training platforms and bases [2]. - The city will enhance its talent introduction, training, evaluation, and incentive mechanisms, focusing on attracting high-level and innovative young talents [2]. Group 3: Enterprise and Industry Growth - Suzhou targets the cultivation of 50 intelligent native enterprises, 15 unicorn companies, and 100 city-level unicorn nurturing enterprises by 2026 [2]. - The city plans to nurture 490 provincial-level specialized and innovative enterprises and 1,200 high-tech enterprises in the AI sector by the end of 2026 [3]. Group 4: Infrastructure and Ecosystem Development - Suzhou will select 20 city-level AI industrial parks and develop 3 benchmark parks and 5 characteristic parks to enhance industrial agglomeration effects [3]. - The city is focused on developing embodied intelligence industries and building a complete industrial chain for intelligent vehicle networking [3].

Core Viewpoint - The article discusses the recently approved "Development Plan for Open Innovation of the Biopharmaceutical Industry Chain in China (Jiangsu) Free Trade Pilot Zone," which aims to enhance the biopharmaceutical industry's innovation capabilities and modernize its supply chain by 2030 [2]. Group 1: Key Tasks and Goals - The plan outlines 7 key areas and 18 specific tasks to promote integrated innovation across the entire biopharmaceutical industry chain [2]. - By 2030, the goal is to achieve rapid growth in the biopharmaceutical industry scale, optimize the innovation ecosystem, significantly enhance the modernization level of the industry chain, and improve the level of openness [2]. Group 2: R&D and Innovation - The plan emphasizes the importance of R&D innovation, focusing on advanced treatment methods such as immune cells, stem cells, and gene therapy, as well as innovative medical devices [3]. - Specific measures include strengthening the application of big data and artificial intelligence in drug design and medical device manufacturing, and supporting clinical research in relevant fields [3]. Group 3: Production and Distribution - The plan proposes pilot projects for segmented production of chemical raw materials and biological products, and reforms in the supervision of imported experimental animals [4]. - It aims to enhance the convenience of customs clearance for medical and research materials, leveraging Jiangsu's strong innovation capabilities and complete industry chain [4]. Group 4: Financial Support and Investment - The plan includes significant financial support measures, allowing qualified biopharmaceutical companies to list on various stock exchanges and issue bonds for financing [5]. - It encourages the establishment of investment funds focused on the biopharmaceutical industry and the issuance of real estate investment trusts (REITs) for eligible projects [5]. Group 5: Data Management - The plan highlights the importance of data management in the biopharmaceutical sector, proposing the development of a negative list for data export in this field [6]. - This initiative aims to facilitate efficient data export processes for companies, which is crucial for the overall development of the biopharmaceutical industry [6].

Core Viewpoint - The "Development Plan for the Open Innovation of the Biopharmaceutical Industry Chain in China (Jiangsu) Free Trade Zone" aims to enhance the biopharmaceutical industry's innovation capabilities and modernize its supply chain by 2030, with a focus on key areas such as large molecule biopharmaceuticals, cell and gene therapy, and innovative medical devices [1][2]. Group 1: Key Tasks and Goals - The plan outlines 18 key tasks across seven areas, including enhancing R&D innovation, improving product approval services, and strengthening supply chain systems [1][2]. - By 2030, the goal is to achieve rapid growth in the biopharmaceutical industry scale, optimize the innovation ecosystem, and significantly improve the level of openness and safety assurance capabilities [1][2]. Group 2: Industry Performance and Contribution - In 2024, Jiangsu's biopharmaceutical cluster is projected to generate revenues of 454.39 billion yuan and a profit of 73.04 billion yuan, accounting for 15.1% and 17.9% of the national totals, respectively, making it the leading province in China [2]. - The biopharmaceutical industry within the Jiangsu Free Trade Zone is expected to contribute approximately half of the province's total biopharmaceutical output [2]. Group 3: R&D and Innovation Measures - The plan emphasizes the application of big data and artificial intelligence in drug target screening, molecular design, and medical device manufacturing [2][3]. - It encourages clinical research in advanced treatment methods such as immunotherapy, stem cell therapy, and gene therapy, while supporting the establishment of national and industry standards [2][3]. Group 4: Production and Regulatory Framework - The plan proposes pilot projects for segmented production of chemical raw materials and biological products, as well as reforms in the supervision of imported experimental animals [3]. - It aims to enhance the convenience of customs clearance for medical and research materials, thereby improving the R&D and production environment for companies [3]. Group 5: Financial Support and Investment - The plan includes measures to support biopharmaceutical companies in listing on various stock exchanges and encourages the establishment of investment funds focused on the biopharmaceutical sector [4]. - It also addresses cross-border data flow issues by proposing a negative list for data export in the biopharmaceutical field, which is crucial for foreign investment [4][5].