厦门打造生物医药产业高质量发展新生态

Core Insights - The biopharmaceutical industry is a key strategic emerging industry in Xiamen, Fujian Province, with over 1,800 companies expected by the end of 2025 and an industry scale nearing 100 billion yuan [1] - Xiamen has approved 8 new Class 1 drugs and over 60 new drug varieties for registration or clinical trials, along with 72 Class 3 medical devices, accounting for 90% of the total in Fujian Province [1] Regulatory Support - Xiamen's market regulatory authority emphasizes integrating regulation with service to support high-level innovation in the biopharmaceutical sector [1] - The Xiamen Market Supervision Administration has been enhancing regulatory capabilities, cultivating professional talent, and optimizing industry services to foster a high-quality development ecosystem [1] Technical Support and Quality Assurance - The Xiamen Food and Drug Quality Inspection Institute has successfully entered the national drug sampling quality analysis现场评议环节, having completed over 5,500 batches of sampling tasks since 2009 [2] - The institute is enhancing its inspection and testing capabilities through partnerships in research and development, focusing on cutting-edge technologies like cell and gene testing [2][3] - A new medical device testing center is under construction to meet the growing demand for testing in the biopharmaceutical industry, aiming to cover over 90% of the city's testing needs [3] Talent Development - The Xiamen Market Supervision Administration has implemented a comprehensive training system to enhance the professional skills of drug inspectors, with 183 inspectors certified by the end of last year [5][6] - The administration has established a "1+N" training system, organizing multiple training sessions to improve the regulatory workforce's capabilities [5][6] Industry Collaboration and Efficiency - The Xiamen Market Supervision Administration has facilitated faster product approvals, exemplified by the early approval of a drug by Fengdi Pharmaceutical, which benefited from professional guidance [7] - A dedicated working group has been established to support the high-quality development of the biopharmaceutical industry, streamlining administrative processes for over 60 licensing items [7][8] - Collaborative measures have been introduced to support the biopharmaceutical industry, including 20 initiatives focused on R&D innovation, clinical trials, and regulatory approvals [8]