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进口平均审批时限压缩至1.6天,“中国首用”药械达523种
Hai Nan Ri Bao· 2025-11-06 01:12
Core Insights - The average approval time for imported medical devices and drugs in the Hainan Boao Lecheng International Medical Tourism Pilot Zone has been reduced to 1.6 days, facilitating faster access to international innovations for patients in China [1][2] - The Lecheng Pilot Zone has successfully introduced 523 types of international innovative medical devices and drugs, benefiting over 180,000 patients, and aims to further enhance its medical technology and drug importation efforts [2][3] Group 1 - The first global hormone replacement therapy drug for hypoparathyroidism, parathyroid hormone replacement therapy, has been successfully used by a patient in Hainan, despite not being officially launched in mainland China [2] - The Lecheng Pilot Zone's unique policies, including "licensed medical devices" and "real-world research," have enabled a significant reduction in the approval process for new medical products [2][3] - The introduction of a "zero tariff" policy for imported medical devices and drugs has further streamlined the process, reducing the average approval time from 5 working days to 1 working day [2] Group 2 - The ongoing China International Import Expo has attracted over 30 renowned domestic and international pharmaceutical and medical device companies, indicating strong interest in the Lecheng Pilot Zone [3] - The Lecheng Pilot Zone has established deep cooperative relationships with over 180 pharmaceutical and medical device companies from 20 countries and regions, including many of the top 30 global firms [3] - The management of the Lecheng Pilot Zone plans to refine the tax-exempt catalog for medical devices and drugs, aiming to create a world-class international medical tourism destination and a medical innovation platform [3]
身在乐城,链接全球前沿医疗资源
Hai Nan Ri Bao· 2025-10-14 01:57
Core Viewpoint - Ruijin Hainan Hospital is leveraging institutional innovation to establish itself as a new highland for international medical services in the Hainan Free Trade Port, aiming to connect global medical resources with local patients [3][4][5]. Group 1: Institutional Innovation and Medical Services - Ruijin Hainan Hospital is a key project approved by the Hainan provincial government, officially starting operations in December 2021 and achieving full medical process integration by March 2022 [3][4]. - The hospital has successfully implemented 186 special drug and medical device projects, benefiting over 26,800 patients, significantly reducing the economic burden on patients by negotiating lower prices for these products [5][6]. Group 2: Real-World Research and Clinical Advancements - The hospital is conducting high-quality real-world data research to accelerate the registration and market entry of international innovative drugs and devices in China, exemplified by the rapid approval of Isatuximab injection for multiple myeloma patients [6][7]. - Innovative mechanisms have been established, including a dedicated technical expansion department and a patient management platform, to enhance the accessibility of quality medical resources [6][9]. Group 3: Talent Development and Cultural Integration - The hospital is focusing on a "transfer and cultivate" approach to talent development, aiming to instill the spirit of Ruijin Hospital in Hainan while building a sustainable local talent pool [7][8]. - Collaborative initiatives with Shanghai Jiao Tong University and other institutions are being pursued to provide local talents with international learning and research opportunities [8]. Group 4: Regional Medical Ecosystem and Internationalization - Ruijin Hainan Hospital is enhancing the regional medical ecosystem through platform sharing and resource integration, collaborating with local hospitals to provide high-quality medical services [9]. - The hospital is actively pursuing international cooperation, including partnerships with Southeast Asian medical institutions and exploring international insurance models to improve service standards [9].
一季度乐城特许药械使用人次同比增长超四成
Hai Nan Ri Bao· 2025-05-16 02:40
Core Insights - The Boao Lecheng International Medical Tourism Pilot Zone has seen a significant increase in the usage of special medical devices and drugs, with a reported 44.14% year-on-year growth in usage instances in the first quarter of 2025, reaching 16,000 instances [2] - The collaboration among various departments has led to innovative regulatory measures that have streamlined the approval process, resulting in a substantial increase in the number of approved medical devices and drugs [2][3] Summary by Sections Usage Growth - In the first quarter of 2025, the usage of special medical devices and drugs in Lecheng reached 16,000 instances, marking a 44.14% increase compared to the previous year [2] - The total usage for 2024 is projected to exceed 51,000 instances, reflecting a 79.33% year-on-year growth [2] - The value of special medical devices entering the bonded warehouse reached 602 million yuan, an 18% increase year-on-year [2] Regulatory Innovations - Since 2021, the provincial drug regulatory authority, health commission, and customs have implemented measures to support high-quality development in the Lecheng pilot zone, including adjustments to the approval process [2] - The approval process has shifted from a "one person, one product, one batch" model to a "one product, one hospital, one batch" model, significantly increasing the number of approvals [2] Patient and Institutional Engagement - The implementation of a drug and device exit registration measure has led to a noticeable increase in patient willingness to use these products, benefiting over 17,000 patients [3] - The regulatory authority is focusing on patient needs and is actively seeking products that can create usage scale and extend the industry chain [3] - A shared service platform for special medical devices and drugs is being developed to enhance communication and service delivery, transforming the approval process from passive to proactive [3]