江苏自贸区发布生物医药发展方案 剑指2030年产业集群目标 支持AI医疗、基因治疗等发展

Core Viewpoint - The Jiangsu Free Trade Zone aims to enhance the biopharmaceutical industry through an open innovation development plan, targeting significant growth and modernization by 2030 [4][5]. Group 1: Overall Requirements - The plan is guided by Xi Jinping's thoughts and aims to create a globally influential biopharmaceutical hub in Jiangsu, focusing on high-quality development and safety [4][5]. Group 2: Enhancing R&D Innovation Capabilities - The initiative supports major national science and technology projects in biopharmaceuticals, emphasizing breakthroughs in innovative drugs and high-end medical devices [5][6]. - It promotes the application of big data and artificial intelligence in drug design and medical device manufacturing [5][6]. - The establishment of a national biopharmaceutical technology innovation center in Suzhou is encouraged to facilitate technology transfer and application [6][7]. Group 3: Improving Product Approval Services - The plan aims to optimize drug review services and enhance the approval process for innovative drugs and medical devices [8][9]. - It includes strengthening inspection and testing capabilities for biological products, particularly vaccines [8][9]. Group 4: Building a Biopharmaceutical Production and Distribution System - The initiative focuses on developing advanced manufacturing clusters for biopharmaceuticals and high-end medical devices [9][10]. - It aims to enhance customs facilitation for medical devices entering special regulatory zones [9][10]. Group 5: Enhancing Procurement and Usage Policies - The plan encourages the inclusion of eligible innovative drugs in the national medical insurance catalog and aims to streamline the approval process [10][11]. - It explores the introduction of AI-assisted diagnostic technologies in medical services [10][11]. Group 6: Increasing Support for Key Elements - The initiative proposes a market-oriented evaluation mechanism for talent in the biopharmaceutical sector [11][12]. - It supports financial backing for innovative biopharmaceutical companies through various funding avenues [11][12]. Group 7: Ensuring Safety and Risk Management - The plan emphasizes the importance of safety management in biopharmaceutical production and the need for robust risk assessment mechanisms [13][14]. - It aims to align regulatory capabilities with international standards to enhance drug and medical device oversight [13][14].