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 当好"哨兵"，守护百姓用药安全 海南日报全媒体记者 李梦瑶 "手套破裂现象多次出现，可能与产品质量相关。"不久前，海南省药物警戒中心通过监测系统发 现，某哨点医院在短时间内集中上报多例疑似同一厂家相同(邻)批号的一次性使用灭菌橡胶外科手套的 不良事件。 一双医用手套，很可能就是守护生命的关键防线，根本马虎不得。调查分析，抽样检验，行政处 罚……在省药物警戒中心与药监部门的联合处置下，一个"产品质量不合格"的风险隐患被迅速消除。 处理类似事件是省药物警戒中心的工作日常。"除了类似的医疗器械不良事件，合格药品在正常用 法用量下，也可能出现与用药目的无关的有害反应。"该中心主任黄凌介绍，她和同事们的主要职责便 是对这些不良反应、不良事件进行监测评估，防范化解潜在安全风险。 换句话说，省药物警戒中心就像是保障公众用药安全的"哨兵"。 "该平台打破了各部门数据壁垒，建成之后，风险监测将更智慧化、便捷化。"黄凌说。 与兄弟省份相比，海南省药物警戒中心除了开展常规药品监测工作，还拥有独一无二的附加任务： 得益于国家给予海南先行先试的特许药械政策，许多已在国外上市、未在 ...

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]

推动生物医药产业创新发展。聚焦产业在创新发展中遇到的堵点问题，持续提升临床研究水平、加 大中药研发创新的支持力度等4项工作措施，从制度设计上鼓励激发创新。力争到2027年底推动15个以 上院内制剂开展注册或备案。依托热带植物资源优势，推动海南特色化妆品新原料开发，助力化妆品产 业异军突起。 推动监管创新和扩大对外开放。聚焦真研等监管创新推动产品参与国际竞争，打造真实世界研究应 用高地、积极试点分段生产模式、推动产品进口便利化、支持国产产品扬帆出海、提升流通新业态监管 质效等5项工作措施，促进境外消费回流。其中，进一步拓展"乐城研用+海口/琼海生产"模式，推动更 多创新药械实现本地化生产。 海南出台药品医疗器械化妆品监管改革实施方案，提出20条改革举措 力争每年引进特许药械60种以上 海南日报海口4月29日讯(海南日报全媒体记者 王洪旭)4月29日，海南日报全媒体记者从"海南自贸 港政策解读"系列主题新闻发布会(第三十六场)上获悉，《海南省全面深化药品医疗器械化妆品监管改 革促进医药产业高质量发展实施方案》(以下简称《实施方案》)出台，提出5个方面20条改革举措，全 面深化药品医疗器械化妆品监管改革，建设与自贸 ...