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海南产经新观察:乐城先行区,从“政策试验田”到“产业新高地”
Zhong Guo Xin Wen Wang· 2025-09-25 12:17
Core Insights - The Hainan Boao Lecheng International Medical Tourism Pilot Zone is transitioning from a "policy testing ground" to an "industrial highland" with the establishment of the Hainan International Innovative Drug and Medical Device "Three Medical Collaboration" Trusted Data Space [1][4] Group 1: Development and Achievements - The Hainan International Innovative Drug and Medical Device Trusted Data Space has been approved as a national pilot for industry trusted data space innovation, making it the only pilot in the health sector nationwide [3] - Over the past decade, the Lecheng Pilot Zone has introduced more than 510 innovative drugs and medical devices globally, collaborating with over 180 companies from 20 countries [4] - The application of real-world data in drug and medical device registration has reduced the average domestic listing time for global innovative products by 1.5 years [4] Group 2: Future Plans and Goals - The Lecheng Pilot Zone aims to enhance the integrity and application value of real-world data by addressing technical and institutional challenges in medical data circulation [3][4] - The initiative will focus on creating a data-driven ecosystem that integrates drug and medical device research, medical services, and healthcare regulation [5] - The goal is to establish the trusted data space as an incubator for innovation in the healthcare industry, promoting cross-border clinical research and international telemedicine [5]
乐城医疗先行区药监局常务副局长安平:特许药械政策引领医疗创新 乐城想做市场主体的“店小二”
Jing Ji Guan Cha Bao· 2025-05-19 10:48
Core Insights - The Hainan Boao Lecheng International Medical Tourism Pilot Zone has achieved significant progress in its special drug and medical device policy, with 476 imported special drugs and devices as of April 30, 2025, including 175 drugs and 301 devices [1] Group 1: Policy Advantages - The Lecheng Pilot Zone has four core policy advantages: special drug and device policy, real-world research policy for drugs and devices, real-world research policy for medical insurance, and special operation policy for public hospitals [1] - The special drug and device policy allows the import and use of new drugs and devices that have not yet been approved in China, enabling patients to access the latest global medical innovations more quickly and conveniently [1] Group 2: Future Plans - The Lecheng Medical Supervision Bureau plans to focus on "medical" as the core and actively serve the introduction of special drugs and devices through a traceability platform, transitioning from passive approval to proactive service [2] - The zone aims to introduce a full range of special drugs and devices related to specific diseases and specialties, creating a comprehensive multidisciplinary center for disease management [2] - The plan includes expanding the entire industrial chain of special drugs and devices through real-world data research and medical-engineering transformation, positioning Lecheng as a new highland for drug and device research and development [2] Group 3: Regulatory Commitment - The special drug and device policy is regarded as Lecheng's "golden signboard," with a commitment to maintaining medical safety, ethical safety, and policy safety [3] - The Lecheng Medical Supervision Bureau will continue to support the application of special drugs and devices and real-world data research while strengthening regulation to ensure medical safety [3]