江苏自贸试验区生物医药国家级改革方案落地

Core Insights - The core viewpoint of the news is the approval and implementation of the "Biopharmaceutical Industry Chain Open Innovation Development Plan" in Jiangsu, which aims to enhance the biopharmaceutical sector through comprehensive reforms and innovative measures [1][2]. Group 1: Key Features of the Plan - The plan is characterized by its originality, being the first in the nation to propose an open innovation development for the entire biopharmaceutical industry chain, and it is the first province approved for biopharmaceutical pilot projects [1]. - The plan integrates 18 policy measures across six areas, emphasizing a full-chain reform that connects research, manufacturing, distribution, and usage [2]. Group 2: Implementation Measures - The plan includes measures to enhance R&D innovation capabilities, improve product approval services, and construct a biopharmaceutical production and distribution system [2]. - In the R&D phase, the plan aims to expedite the approval process for generic drugs, allowing for a more streamlined application process and faster market entry [2]. - The manufacturing phase will see a relaxation of current policies that require biopharmaceuticals to be produced in the same location, enabling segmented production trials [2]. Group 3: Global Resource Allocation - The plan promotes global resource allocation by facilitating high-level talent recognition and allowing foreign medical professionals to practice in Jiangsu, enhancing local access to international medical expertise [3]. - A negative list for data management will be implemented, reducing the time required for data export assessments by 30% to 50% [3]. Group 4: Focus on High-Level Innovation - The plan emphasizes high-level innovation by targeting cutting-edge areas such as gene and cell therapy and brain science, with a focus on overcoming key technological challenges [3]. - It supports the participation of enterprises in setting national and industry standards for innovative medical products and devices [3]. Group 5: Industry Impact - Jiangsu's biopharmaceutical industry accounts for one-eighth of the national market, with approximately one-third of innovative drugs approved in the country, showcasing its leading position [4]. - The implementation of this plan is expected to strengthen Jiangsu's role as a highland for reform and innovation in the biopharmaceutical sector, enhancing the business environment for enterprises [4].