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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]
医疗与消费周报:药物警戒行业:AI“东风”正盛,国内工作水平稳健提升-20250604
Huafu Securities· 2025-06-04 11:37
Group 1 - The report highlights that the pharmaceutical index has shown positive returns across most of the six sub-industries, indicating a strong performance in the sector [1][9]. - The draft of the "Best Practice Framework for AI in Pharmacovigilance" was released on May 1, aiming to guide the development and application of AI in monitoring adverse drug reactions. This technology is expected to bring revolutionary improvements to drug safety monitoring, although a risk-oriented regulatory and governance system is necessary [2][7]. - According to the "China Pharmacovigilance Industry Research Report," the Chinese pharmacovigilance market is experiencing significant growth, with 2.419 million adverse drug reaction reports filed in 2023, reflecting an improvement in monitoring capabilities [2][8]. Group 2 - The report notes that the global pharmacovigilance market was valued at 58.568 billion in 2022 and is projected to grow at a CAGR of 10.02%, reaching approximately 103.894 billion by 2028 [8]. - The report emphasizes that the domestic AI healthcare models are rapidly developing, and the pharmacovigilance industry is expected to continue its strong growth trajectory, necessitating the establishment of a comprehensive regulatory framework [8]. - The report indicates that the innovation drug sector is entering a harvest period, supported by strong policy backing and innovation-driven growth, which is expected to enhance the overall performance of the pharmaceutical sector [16][20].