江苏自贸试验区生物医药产业启动全链条改革 “全程绿灯”加速好药上市步伐

Core Insights - The "China (Jiangsu) Free Trade Zone Biopharmaceutical Industry Chain Open Innovation Development Plan" was approved by the State Council in August, aiming to accelerate the entire process from laboratory research to clinical use, facilitating faster access to innovative drugs for patients [1][2] Group 1: Key Concepts - The plan is structured around three main keywords: "full-chain reform," "institutional openness," and "high-level innovation," which together create a comprehensive innovation system covering the entire biopharmaceutical industry cycle [2][3] - The "full-chain reform" addresses six areas with 18 specific policy measures aimed at enhancing R&D capabilities, improving approval services, and optimizing production and circulation systems [2][5] - Jiangsu's biopharmaceutical industry accounts for 12.5% of the national market, with one-third of the country's approved innovative drugs, highlighting its leading position [2][6] Group 2: Institutional Openness - The plan allows foreign professionals with recognized international qualifications to work in Jiangsu without needing to pass domestic qualification exams, enhancing local access to global expertise [3][4] - The management of outbound data will see a reduction in evaluation time by 30% to 50%, facilitating smoother cross-border data flow for R&D [3][6] Group 3: High-Level Innovation - The focus is on cutting-edge fields such as gene and cell therapy, with initiatives to support companies in participating in standard-setting and establishing innovation centers [3][4] - The plan encourages the use of AI in drug development, aiming to reduce costs and improve efficiency in the biopharmaceutical sector [4][5] Group 4: Addressing Industry Bottlenecks - The plan is designed to resolve specific industry challenges, such as streamlining the export process for genetically modified laboratory animals, which previously faced dual regulatory hurdles [5][6] - A total of 34 policy measures related to drug supervision are included, with significant support from national regulatory bodies to enhance the local pharmaceutical landscape [6][7] Group 5: Implementation Strategies - Jiangsu will implement reforms through regional collaboration, detailed management lists, and enhanced departmental coordination to ensure effective execution of the proposed measures [7] - The plan includes a focus on creating specialized biopharmaceutical clusters and promoting innovation through collaborative efforts among enterprises and research institutions [7]