商务部、江苏省人民政府印发《中国（江苏）自由贸易试验区生物医药全产业链开放创新发展方案》

Core Viewpoint - The "China (Jiangsu) Free Trade Pilot Zone Biopharmaceutical Industry Chain Open Innovation Development Plan" aims to enhance the biopharmaceutical industry in Jiangsu, focusing on innovation, international competitiveness, and high-quality development by 2030 [5][6]. Group 1: Overall Requirements - The plan is guided by Xi Jinping's thoughts and aims to create a world-class biopharmaceutical industry cluster in Jiangsu, with significant growth in industry scale and modernization by 2030 [6]. - Key areas of focus include breakthroughs in major technologies, especially in large molecule biopharmaceuticals, cell and gene therapy, and innovative medical devices [6]. Group 2: Enhancing R&D Innovation Capability - Support for national major projects in biopharmaceuticals and medical devices, emphasizing the use of big data and AI in drug design and medical device manufacturing [7]. - Establishment of a national biopharmaceutical technology innovation center in Suzhou and promotion of health data management standards [7][8]. - Encouragement of international collaborative research and optimization of clinical trial approval processes for foreign investments [8]. Group 3: Improving Product Approval Services - Optimization of drug review services to prioritize innovative drugs and medical devices, including AI medical service software [9]. - Enhancement of inspection and testing capabilities for biopharmaceuticals, particularly vaccines [9]. Group 4: Building Production and Distribution Systems - Development of advanced manufacturing clusters for biopharmaceuticals and high-end medical devices, including contract research and production services [10]. - Improvement of customs facilitation for medical devices not sold in China [10]. Group 5: Procurement and Usage Policies - Promotion of innovative drugs into the national medical insurance catalog and optimization of the listing process [11]. - Expansion of medical service offerings to include AI-assisted diagnostic technologies [11]. Group 6: Strengthening Support and Guarantee Measures - Implementation of talent evaluation policies tailored to the biopharmaceutical industry and facilitation of work permits for foreign medical professionals [12]. - Financial support for innovative biopharmaceutical companies through various funding mechanisms, including public offerings and investment funds [12][13]. Group 7: Ensuring Safety and Risk Management - Strengthening safety production supervision in the biopharmaceutical sector and enhancing risk management for high-risk products [14]. - Building regulatory capabilities in line with international standards for drug and medical device oversight [14]. Group 8: Collaborative Implementation - Jiangsu Provincial Government is responsible for implementing the plan, with support from various national departments to ensure effective execution [15].