（来源：沈阳日报） 本报讯（沈阳日报、沈报全媒体记者宋宇）1月26日记者获悉，沈阳药科大学获批成为"国家药品监督管 理局监管科学创新研究基地（化药领域）"，这标志着该校在化药监管科学研究领域跻身国家战略梯 队，将为我国药品监管体系与监管能力现代化注入新动能。 据悉，国家药品监督管理局共批准29个监管科学创新研究基地，涵盖中药、化药、生物制品、医疗器 械、化妆品及共性研究等多个领域。沈阳药科大学作为国家药监局原首批监管科学基地及重点实验室依 托单位，在监管科学理论研究、药物研发技术创新等领域积累深厚。此次获批后，学校将联合辽宁省检 验检测认证中心、黑龙江省药品检验研究院两家共建单位，整合检验检测技术资源，构建跨区域科研协 同机制。 基地将重点开展慢病治疗药物及复杂制剂的质量控制、变更管理与智能监管技术，以及麻醉药品与精神 药品的质量控制技术、依赖性评价等前沿方向研究。通过建设慢病、麻醉药品和精神药品监管科学创新 研究平台，推动化学药品全生命周期监管工具、标准和方法创新，加强监管科学专业人才培养。未来， 基地将紧扣我国化学药品监管实际需求，对标国际监管科学发展前沿，依托"政产学研用"协同机制，构 建从理论研究、技 ...

第四届博鳌国际药械真实世界研究大会举行 《真实世界数据与监管科学》创刊 海南日报博鳌11月24日电(海南日报全媒体见习记者 王子豪)11月22日至23日，第四届博鳌国际药 械真实世界研究大会在琼海博鳌举办。本届大会围绕"真实世界研究助力创新药械临床评价"主题，吸引 国际组织以及国内外监管机构、知名医疗机构、顶尖科研院校、跨国药械企业等真实世界研究相关领域 的专家学者及嘉宾700余人共聚一堂，分享最新药械监管科学理念，展示先进科研成果，共同推进全球 健康事业发展。 本届大会设置了真实世界研究与药品临床评价等10个分论坛，以及真实世界研究能力提升专题培训 会和真实世界证据支持药物决策国际经验分享等3个研讨会。 会上举行了国际学术期刊《真实世界数据与监管科学》创刊仪式，旨在汇聚真实世界数据辅助监管 决策的国际前沿技术和应用案例，为监管科学提供新工具、新标准、新方法，助力乐城打造全球学术高 地。 作为真实世界研究领域的年度盛会，博鳌国际药械真实世界研究大会已连续举办4届，成为国际真 实世界研究交流的重要平台，向世界传递出真实世界研究的中国声音。 ...

Core Insights - Beijing has positioned the pharmaceutical and health industry as one of the "dual engines" for innovative development, with the industry scale expected to reach one trillion yuan by 2024 [2] - The 2025 Zhongguancun Forum focused on regulatory science and high-quality development in the biopharmaceutical sector, emphasizing the importance of regulatory policies in supporting industry growth [2] - In 2024, a total of 3,332 new drugs were approved nationwide, including 48 innovative drugs, 106 pediatric drugs, and 55 rare disease drugs, indicating a growing focus on innovation and specialized treatments [2] Group 1 - Beijing has implemented the "32 measures" to promote innovative pharmaceutical development, significantly reducing review times for drug applications and clinical trials [3] - The city has established a green channel for urgently needed imported drugs and medical devices, with an import value exceeding 150 billion yuan in 2024, ranking first in the country [3] - Major pharmaceutical companies, including Pfizer and Merck, have established new innovative entities in Beijing, enhancing the city's attractiveness for global pharmaceutical innovation resources [3] Group 2 - The Beijing Drug Administration will continue to optimize review and approval processes to facilitate the rapid application of innovative results and improve regulatory efficiency [4] - Beijing has a natural advantage in building data platforms due to its concentration of top-tier hospitals and national medical research centers, which generate vast amounts of clinical data [5] - The integration of medical and insurance data is seen as beneficial for enhancing drug development capabilities and regulatory cooperation [5] Group 3 - Suggestions have been made to establish a phased submission mechanism for new drug applications, which could shorten the preparation time by 3 to 6 months [6] - Recommendations include reducing the number of required test samples for rare disease drugs and exploring a dynamic regulatory model to streamline the approval process [6]