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]