"全程绿灯"加速好药上市步伐 今年8月，《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》获得国务院批复并正 式发布。9月16日，省政府召开新闻发布会，深度解读该方案背后的"首创性"与"集成性"，以3个关键词 勾勒出江苏生物医药产业开放创新的新蓝图：从实验室研发到临床使用全流程加速，让"好药"研发、通 关、使用环节实现"全程绿灯"；从全球高端人才到跨境数据资源自由流通，让百姓在家门口就能挂上外 籍专家号……这场覆盖全链条的改革实践，让"江苏造"创新药离市场更近，更快造福患者，折射民生温 度。 该方案以问题为导向，在流程效率、资源配置、创新生态等关键领域实现突破性进展，让政策红利真正 看得见、摸得着、用得上。 "方案自酝酿之初，就坚持以解决企业的困难诉求为制度创新的出发点和突破口。文件的起草过程，就 是帮助企业解决问题的过程。"司勇举例说，方案第9条"进出境实验动物监管模式改革"便源于企业困 境。省内一家基因工程小鼠企业，其携带人类基因的实验小鼠是新药研发关键模型动物，因携带人类遗 传物质，此前需接受特殊物品与实验动物出口双重监管，通关耗时久。但小鼠生命周期短，常未完成监 管就长成成年鼠，丧失实验价 ...

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]