药品医疗器械审评审批制度改革
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海南省药品和医疗器械审评服务中心乐城分中心成立
Hai Nan Ri Bao· 2025-12-29 01:28
海南日报讯(海南日报全媒体记者 王子豪)为深入推进药品医疗器械审评审批制度改革,持续优化 海南自贸港医药产业营商环境,加速博鳌乐城国际医疗旅游先行区医药创新成果转化与产业集聚,近 日,海南省药品和医疗器械审评服务中心乐城分中心(以下简称乐城分中心)揭牌成立。 据悉,设立乐城分中心是海南省药监局、琼海市政府与乐城先行区管理局适应封关运作新形势、推 动药械监管理念与服务模式创新的重要举措。该中心将致力于打造集"政策连心桥""技术指导员""审批 加速器"于一体的专业化、一站式服务平台,当好"守门员""服务员",强化"部省区"上下联动,释放出 更多改革红利,破解产业痛点,探索治理新路,更好地服务于乐城先行区高质量发展。 下一步,海南省药监局将联合琼海市政府、乐城先行区管理局等相关部门,以乐城分中心成立为新 起点,以落实支持生物医药产业高质量发展措施为抓手,持续加强监管能力建设和专业人才培养,积极 探索与国际接轨的监管服务机制,努力打造具有海南特色、乐城优势的药品医疗器械审评服务样板,为 更好释放国家药监局支持高标准建设海南自贸港的政策红利、推动海南医药产业高质量发展提供坚实保 障。 ...
国家药品和医疗器械审评检查京津冀分中心在北京挂牌运行
Bei Jing Shang Bao· 2025-09-21 06:53
Core Viewpoint - The establishment of the Beijing-Tianjin-Hebei (Jing-Jin-Ji) Center for Drug and Medical Device Review and Inspection is a significant step by the National Medical Products Administration (NMPA) to enhance the drug and medical device approval system, promote innovation, and support high-quality development of the regional pharmaceutical industry [1][2] Group 1: Center Functions and Responsibilities - The Jing-Jin-Ji Center will serve the regions of Beijing, Tianjin, Hebei, and Shandong, providing technical services related to drug and medical device review, including research guidance, consultation acceptance, and review communication [1] - The center will also undertake registration verification and conduct inspections, contributing to the overall efficiency and quality of the review process [2] Group 2: Regional Pharmaceutical Industry Impact - Since 2021, the Jing-Jin-Ji region has approved 34 innovative drugs, accounting for 16.2% of the national total, and 68 Class III innovative medical devices, representing 25.7% of the national total [1] - The pharmaceutical industry's revenue in the region is projected to reach 841.5 billion yuan in 2024, which will constitute 28.3% of the national revenue [1]