“全程绿灯”加速好药上市步伐

Core Insights - The "Jiangsu Free Trade Zone Biopharmaceutical Industry Chain Open Innovation Development Plan" was approved by the State Council, aiming to accelerate the entire process from laboratory research to clinical use, facilitating faster access to innovative drugs for patients [1][2] - The plan emphasizes "full-chain reform, institutional openness, and high-level innovation" to address pain points in the biopharmaceutical industry, with 18 specific measures across six key areas [2][5] Full-Chain Reform - The plan aims to enhance research and innovation capabilities, improve approval services, build production and circulation systems, refine procurement policies, increase resource guarantees, and maintain safety standards [2][5] - Jiangsu's biopharmaceutical industry accounts for 1/8 of the national scale, with 1/3 of innovative drugs approved, indicating its leading position in the country [2][6] - Specific reforms include expediting the approval process for generic drugs, reducing fixed asset investment by 30% through segmented production, and eliminating barriers for innovative drugs to reach the market [2][5] Institutional Openness - The plan allows foreign professionals with recognized qualifications to work in Jiangsu without needing to pass domestic exams, facilitating access to international medical expertise for local residents [3][5] - The management of outbound data will see a reduction in evaluation time by 30%-50%, enhancing cross-border data flow for research [3][5] High-Level Innovation - Focus areas include gene and cell therapy, brain science, and the establishment of platforms like the National Biopharmaceutical Technology Innovation Center [3][4] - The plan encourages companies to participate in standard-setting and broadens financing channels through credit bonds [3][4] Addressing Industry Bottlenecks - The plan is problem-oriented, targeting key areas such as process efficiency and resource allocation to ensure tangible benefits for enterprises [5][6] - For instance, reforms in the regulation of experimental animals aim to reduce export clearance times by approximately 50%, addressing specific challenges faced by companies [5][6] Ensuring Effective Reform - Jiangsu will implement measures to ensure that reforms transition from paper to practice, focusing on regional collaboration and detailed management [7] - The plan includes a task list to clarify responsibilities and timelines, ensuring that the 18 measures are effectively executed [7]