Workflow
特许药械
icon
Search documents
世界侨商海南行:共享自贸港封关前的“黄金窗口期”
Zhong Guo Xin Wen Wang· 2025-08-27 08:04
Core Viewpoint - Hainan Free Trade Port will officially start its island-wide customs closure operation on December 18 this year, creating investment opportunities in various sectors, particularly for overseas Chinese merchants [1][2]. Group 1: Investment Opportunities - Qionghai City is promoting investment opportunities in sectors such as healthcare, tropical agricultural processing, cross-border trade, and cultural tourism, aiming to collaborate with overseas Chinese merchants during the "golden window period" before the customs closure [2]. - The city has established a modern industrial system focusing on four main industries: healthcare, conference tourism, tropical high-efficiency agriculture, and marine economy, along with a "1+2+3" framework for development [2]. Group 2: Healthcare Sector - The Boao Lecheng International Medical Tourism Pilot Zone, as China's only "medical special zone," has introduced innovative systems such as "licensed drugs and devices" and "real-world data research," attracting 36 top medical institutions and 502 innovative licensed drugs and devices that are available abroad but not yet in China [5]. - The participation of 27 overseas Chinese merchants in the inspection of Lecheng's quality medical resources highlights the development vitality brought by the free trade port policy [5]. Group 3: Strategic Development - Qionghai aims to enhance its appeal to overseas Chinese merchants by offering the most open posture, favorable policies, and high-quality services to ensure comprehensive support for their investment and business activities [5].
世界侨商海南行:“医疗特区”受关注
Zhong Guo Xin Wen Wang· 2025-08-27 02:40
Core Insights - The focus of the visit is on gene diagnosis and stem cell research, aiming to explore cooperation opportunities in medical technology and high-tech talent exchange [1] - The Hainan Boao Lecheng International Medical Tourism Pilot Zone is recognized as China's only "medical special zone," attracting attention from overseas Chinese business representatives [1][3] Group 1: Lecheng Pilot Zone - The Lecheng Pilot Zone is one of the 13 key parks in Hainan Free Trade Port, featuring high-end medical tourism services and cutting-edge pharmaceutical technologies [3] - The zone has approved the introduction of 502 special medical products from countries including the USA, Japan, Australia, and parts of Europe [3] - The unique preferential medical policies in the zone simplify the approval process for stem cell applications, facilitating the normalization of clinical treatments [3] Group 2: Future Development Plans - Qionghai City plans to develop the Fuhai Industrial Zone, focusing on attracting and nurturing biopharmaceutical, marine pharmaceuticals, and medical device companies [2] - The development model aims for a synergistic growth between the Lecheng Pilot Zone and the Fuhai Industrial Zone, creating a "front store and back factory" approach [2] - The Fuhai Industrial Zone will also establish a surgical robot technology park, aligning with investment interests in intelligent manufacturing and healthcare [4] Group 3: Investment Opportunities - There is significant potential for the integration of artificial intelligence and healthcare industries, especially with the upcoming full closure of the Hainan Free Trade Port [5] - Companies are actively seeking cooperation opportunities to leverage the benefits of the Hainan Free Trade Port's preferential policies [5]
省药物警戒中心强化多方协同 借力数智化工具做好风险监测
Hai Nan Ri Bao· 2025-07-12 00:23
Core Viewpoint - The Hainan Provincial Drug Vigilance Center is enhancing collaboration and utilizing digital tools to improve risk monitoring and ensure medication safety for the public [1][2][3] Group 1: Risk Monitoring and Response - The center identified multiple adverse events related to a specific batch of disposable surgical gloves, indicating potential quality issues [2] - The center's primary responsibility includes monitoring and evaluating adverse reactions and events to mitigate potential safety risks [2][3] - Hainan's drug adverse reaction report total is slightly above the national average, while the center's staff is only one-third of the national average for provincial monitoring agencies, indicating a high workload [3] Group 2: Collaborative Efforts and Training - The center collaborates with the Provincial Health Commission to establish a coordinated assessment mechanism, integrating monitoring into the accountability system for medical institutions [4] - The number of monitoring points has been expanded, and specialized training for monitoring personnel is ongoing to enhance sensitivity in detecting risks [4] Group 3: Digital Tools and Innovations - The center is integrating risk signal identification and rapid reporting of adverse drug reactions into the Hainan "Three Medical Linkage One Network" platform [4][5] - This platform aims to eliminate data silos among departments, making risk monitoring more intelligent and convenient [5] Group 4: Unique Responsibilities and Advantages - Hainan's drug vigilance center has unique tasks due to special policies allowing early use of innovative medical devices not yet registered in China [5][6] - The center has established a comprehensive monitoring system for innovative medical devices used in the Boao Lecheng area, focusing on patient registration, clinical follow-up, and lifecycle traceability [6][7] - The center aims to leverage its policy advantages to enhance research capabilities and improve the drug vigilance system and risk management [7]
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]
海南出台药品医疗器械化妆品监管改革实施方案
Hai Nan Ri Bao· 2025-04-30 01:59
Core Viewpoint - The implementation plan for the reform of drug, medical device, and cosmetic regulation in Hainan aims to enhance the competitiveness of the biopharmaceutical industry by introducing 20 reform measures across five key areas [1][2] Group 1: Regulatory Reforms - The plan emphasizes improving the efficiency of review and approval processes, focusing on the actual needs of enterprises during product development and registration [1] - It aims to facilitate the market entry of innovative products, targeting the launch of at least one innovative product annually and the introduction of over 60 licensed medical devices each year [1] Group 2: Innovation in Biopharmaceuticals - The initiative seeks to address bottlenecks in innovation by enhancing clinical research levels and increasing support for traditional Chinese medicine research and development [2] - By the end of 2027, the goal is to promote the registration or filing of over 15 hospital preparations [2] Group 3: International Competitiveness - The plan includes regulatory innovations to enhance product participation in international markets, aiming to create a high ground for real-world research applications [2] - It promotes the "Research and Use + Haikou/Qionghai Production" model to facilitate local production of more innovative drugs and medical devices [2] Group 4: Industry Development - The implementation of the plan is expected to significantly promote structural adjustments, efficiency transformations, and quality improvements in Hainan's biopharmaceutical industry [2] - It aims to create a unique competitive advantage for Hainan's biopharmaceutical sector, contributing to the establishment of a modern industrial system with Hainan characteristics [2]
在博鳌感受开放的中国
Xin Hua Wang· 2025-03-24 07:25
Core Insights - The article highlights the development of Boao, Hainan, as a symbol of China's openness, particularly in the context of the upcoming Boao Forum for Asia annual conference in 2025 [2] - Boao Lecheng International Medical Tourism Pilot Zone is emphasized as a new high ground for China's medical openness and cooperation, showcasing significant achievements in the introduction of innovative drugs and medical devices [2][3] Medical Industry - Over 460 types of first-use licensed drugs and medical devices have benefited 110,900 patients, with 2024 seeing a 79.3% increase in licensed medical device usage and a 36.8% increase in medical tourism visits [3] - The introduction of visa-free policies for 59 countries and transit visa exemptions for China has facilitated international medical tourism, with a notable increase in per capita spending exceeding 12,000 yuan [3] Cultural and Tourism Development - The article discusses the cultural exchanges and exhibitions at the Hainan South China Sea Museum, which enhance local cultural heritage and tourism [6][7] - The local government is focusing on rural revitalization through cultural industry empowerment, creating beautiful rural clusters around the forum venue [9]