生物医学技术创新
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规范生物医学新技术研发应用 两部门解读《生物医学新技术临床研究和临床转化应用管理条例》
Zhong Guo Jing Ji Wang· 2025-10-11 04:06
Core Viewpoint - The "Regulations on the Management of Clinical Research and Clinical Translation Applications of New Biomedical Technologies" will take effect on May 1, 2026, aiming to enhance the management of biomedical technology research and application in China [1] Group 1: Background and Purpose - Biomedical technology has significant potential in disease prevention, diagnosis, and treatment, driving medical progress and health development [2] - The regulations aim to improve the management system for clinical research and application of new biomedical technologies, ensuring safety and quality in medical practices [2] Group 2: Overall Approach - The regulations focus on prioritizing public health, risk prevention, and safety assurance while promoting innovation in biomedical technology [3] - Responsibilities of clinical research institutions and sponsors are clearly defined to ensure accountability [3] Group 3: Scope of Application - The regulations apply to clinical research and translation applications of biomedical technologies within China, defining biomedical technologies as those that operate at the cellular and molecular levels [4] Group 4: Regulations on Clinical Research - Clinical research can only commence after non-clinical studies prove safety and efficacy, and after ethical reviews [5] - Clinical research institutions must adhere to approved research protocols and conduct follow-up monitoring of participants [5] Group 5: Support for Clinical Translation Applications - The regulations establish conditions and procedures for the clinical translation of biomedical technologies, requiring approval from health authorities [6][7] - Quality and safety of clinical applications are emphasized, with specific requirements for medical institutions and personnel [6] Group 6: Protection of Participants' Rights - The regulations outline the protection of participants' rights, including obtaining informed consent and ensuring no fees are charged for participation [8] - Institutions are encouraged to provide insurance for participants and protect their personal information [8] Group 7: Implementation Measures - The National Health Commission will enhance awareness and understanding of the regulations through training and outreach [9] - Development of supporting systems and personnel training is essential for effective implementation of the regulations [9]
李强签署国务院令 推动我国生物医学技术创新发展
Xin Hua She· 2025-10-10 11:29
国务院总理李强日前签署国务院令,公布《生物医学新技术临床研究和临床转化应用管理条例》(以下 简称《条例》),自2026年5月1日起施行。 《条例》旨在规范生物医学新技术临床研究和临床转化应用,促进医学科学技术进步和创新,保障医疗 质量安全,维护人的尊严和健康。《条例》共7章58条,主要规定了以下内容。 一是明确总体要求。规定开展生物医学新技术临床研究和临床转化应用应当坚持以人民健康为中心,坚 持创新引领发展,坚持发展和安全并重,鼓励和支持临床研究和临床转化应用,加强全过程安全管理。 二是规范临床研究。规定生物医学新技术经非临床研究证明安全、有效,并通过学术审查、伦理审查 后,方可开展临床研究。开展临床研究应当向国务院卫生健康部门备案,国务院卫生健康部门对已备案 的临床研究进行评估,发现风险及时纠正直至叫停。加强临床研究实施管理,采取措施预防控制和处置 风险。强化受试者权益保护,强调开展临床研究应当尊重受试者意愿,不得向受试者收取费用,造成受 试者健康损害的应当及时治疗。 三是支持转化应用。规定临床研究证明安全、有效,且符合伦理原则的生物医学新技术,经国务院卫生 健康部门批准,可以转化应用于临床,并明确了审批流 ...
国务院常务会议听取前期防汛救灾工作情况和提升北方地区防汛减灾能力汇报等
Xin Hua She· 2025-09-15 00:13
会议指出,民间投资对稳就业稳经济具有重要作用。要聚焦企业关切的突出问题,在扩大准入、打通堵点、强化 保障等方面实施一批务实举措,进一步激发民间投资活力、促进民间投资发展。要拓宽民间投资空间,支持民间资本 加大新质生产力、新兴服务业、新型基础设施等领域投资。要严格落实招标投标领域相关制度规定,保障中小企业政 府采购预留份额,加大中央预算内投资等对民间投资项目的支持力度。要营造公平竞争市场环境,破除限制民间投资 的各种隐性壁垒,加强创新支撑和融资支持,完善服务体系,让民营企业敢投资、有回报。 会议指出,要着眼于为出海企业参与国际合作与竞争提供有力支撑,进一步完善海外综合服务体系。加强协同联 动,统筹法律、金融、物流等领域服务资源,丰富服务产品,构建服务平台,支持有条件的地方打造出海综合服务 港,推动在重点国家建立海外综合服务站,增强商协会服务功能,培育一批跨境服务能力强的专业服务机构。 会议指出,要推动我国生物医学技术创新发展,加快技术研发和成果转化应用,促进生物医药产业提质升级,着 力塑造发展新优势。要坚持发展和安全并重,依法规范临床研究,保障临床应用质量安全,有效防范各类风险,确保 创新成果更好增进人民健康福 ...
中国8月经济数据将公布;美国FOMC利率决策将公布丨一周前瞻
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-15 00:09
Group 1 - The core economic data for August will be released by the National Bureau of Statistics of China, including residential sales prices and industrial output [2][3] - The 2025 World Energy Storage Conference will be held in Ningde, Fujian [2][3] - The U.S. Federal Open Market Committee (FOMC) will announce its interest rate decision this week [2][3] Group 2 - A total of 42 companies in the Shanghai and Shenzhen stock markets will have their restricted shares unlocked this week, amounting to 3.257 billion shares with a total market value exceeding 89.7 billion yuan [3][4] - The top three companies by market value of unlocked shares are: Weigao Medical (15.943 billion yuan), Softcom Power (15.046 billion yuan), and Kangguan Technology (10.590 billion yuan) [3][4] Group 3 - The State Internet Information Office is soliciting opinions to encourage financial institutions to explore the use of digital RMB for cross-border payments [5] - The State Council is promoting innovation in biomedical technology and accelerating the application of research results [6] - Eight departments aim for automobile sales to reach approximately 32.3 million units in 2025, with a target growth of about 3% [7] - The plan includes promoting the industrial application of intelligent connected vehicles and approving L3-level vehicle production [8] Group 4 - The National Health Commission has passed a draft national standard for pre-prepared food safety, which will soon be open for public consultation [9] - The People's Bank of China reported that the broad money supply (M2) reached 331.98 trillion yuan at the end of August, with a year-on-year growth of 8.8% [9] Group 5 - The Ministry of Commerce announced an anti-discrimination investigation into U.S. measures related to integrated circuits starting September 13, 2025 [11] - An anti-dumping investigation will also be initiated for imported related analog chips from the U.S. starting September 13, 2025 [12] Group 6 - Four new stocks will be available for subscription this week, including one from the main board and three from the ChiNext [14][15] - The subscription details include: United Power (12.48 yuan), Jianfa Zhixin (1 yuan), Ruili Kemi (1 yuan), and Yunhan Xincheng (1 yuan) [15] Group 7 - Short-term market trends indicate a potential structural performance that may outperform the overall market, with a focus on sectors like TMT and electric equipment [16][19] - The A-share market is expected to maintain a recovery trend, with specific attention to high-growth technology sectors and consumer segments [18][19]
重磅发布!国常会,最新部署!进一步促进民间投资发展的若干措施
Zheng Quan Shi Bao Wang· 2025-09-13 01:06
Group 1 - The State Council meeting emphasized the need to promote private investment by addressing key concerns of enterprises, expanding access, and enhancing support measures [1] - The meeting highlighted the importance of private investment in driving economic growth, stabilizing overall investment, and expanding social employment, noting that private investment accounts for over half of total investment in China [2] - The meeting discussed the establishment of a comprehensive overseas service system to support Chinese enterprises in international cooperation and competition [1][4] Group 2 - Measures to broaden the scope of private investment include supporting investments in new productive forces, emerging service industries, and new infrastructure [2] - The meeting called for the creation of a fair competitive market environment by removing hidden barriers to private investment and enhancing innovation and financing support [2] - The meeting also focused on fostering a group of professional service institutions with strong cross-border service capabilities to enhance the overseas service system [4]
部署进一步促进民间投资发展若干措施
Xin Hua She· 2025-09-13 01:03
国务院总理李强9月12日主持召开国务院常务会议,听取前期防汛救灾工作情况和提升北方地区防 汛减灾能力汇报,部署进一步促进民间投资发展的若干措施,研究完善海外综合服务体系,审议通过 《生物医学新技术临床研究和临床转化应用管理条例(草案)》。 会议指出,要推动我国生物医学技术创新发展,加快技术研发和成果转化应用,促进生物医药产业 提质升级,着力塑造发展新优势。要坚持发展和安全并重,依法规范临床研究,保障临床应用质量安 全,有效防范各类风险,确保创新成果更好增进人民健康福祉。 会议指出,今年"七下八上"防汛关键期,一些地区极端强降雨频发、受灾较重,有关地方和部门认 真贯彻落实党中央决策部署,全力做好防汛防台风抢险救灾工作。当前虽然防汛关键期已过,但仍面临 洪涝和台风风险,必须始终保持警醒,坚持人民至上、生命至上,毫不放松做好防汛救灾减灾工作。要 加强部门协同、上下联动,扎实做好受灾群众救助、恢复重建、部分地区抗旱减灾等各项工作,突出抓 好秋雨台风防范应对。要适应北方地区雨情汛情变化新特点,坚持问题导向,大力推进流域防洪工程、 城市排涝、气象监测、应急救援等设施建设,优化水库等重大工程调度管理,全方位提升北方地区防汛 ...
实施一批务实举措 激发民间投资活力
Zhong Guo Zheng Quan Bao· 2025-09-12 20:20
会议指出,今年"七下八上"防汛关键期,一些地区极端强降雨频发、受灾较重,有关地方和部门认真贯 彻落实党中央决策部署,全力做好防汛防台风抢险救灾工作。当前虽然防汛关键期已过,但仍面临洪涝 和台风风险,必须始终保持警醒,坚持人民至上、生命至上,毫不放松做好防汛救灾减灾工作。要加强 部门协同、上下联动,扎实做好受灾群众救助、恢复重建、部分地区抗旱减灾等各项工作,突出抓好秋 雨台风防范应对。要适应北方地区雨情汛情变化新特点,坚持问题导向,大力推进流域防洪工程、城市 排涝、气象监测、应急救援等设施建设,优化水库等重大工程调度管理,全方位提升北方地区防汛救灾 减灾能力。 会议指出,要推动我国生物医学技术创新发展,加快技术研发和成果转化应用,促进生物医药产业提质 升级,着力塑造发展新优势。要坚持发展和安全并重,依法规范临床研究,保障临床应用质量安全,有 效防范各类风险,确保创新成果更好增进人民健康福祉。 会议指出,民间投资对稳就业稳经济具有重要作用。要聚焦企业关切的突出问题,在扩大准入、打通堵 点、强化保障等方面实施一批务实举措,进一步激发民间投资活力、促进民间投资发展。要拓宽民间投 资空间,支持民间资本加大新质生产力、新 ...
国常会:拓宽民间投资空间 完善海外综合服务体系 推动我国生物医学技术创新发展,加快技术研发和成果转化应用,促进生物医药产业提质升级
Zheng Quan Shi Bao· 2025-09-12 17:17
Group 1: Flood Prevention and Disaster Relief - The meeting emphasized the importance of maintaining vigilance against flood and typhoon risks, even after the peak flood season has passed, highlighting the need for effective disaster relief and recovery efforts [1] - It was noted that extreme rainfall has caused significant damage in some regions, necessitating coordinated efforts for disaster response and recovery, including drought mitigation in certain areas [1] - The meeting called for improvements in flood prevention infrastructure, including flood control projects, urban drainage systems, meteorological monitoring, and emergency rescue capabilities in northern regions [1] Group 2: Promotion of Private Investment - The meeting recognized the critical role of private investment in stabilizing employment and the economy, proposing practical measures to address key concerns of enterprises and stimulate private investment [2] - It was suggested to expand the scope of private investment, particularly in new productive forces, emerging service industries, and new infrastructure projects, while ensuring fair competition and removing barriers to private investment [2] - The government plans to enhance support for private investment projects through improved procurement policies and increased central budget investments [2] Group 3: Biomedical Technology Development - The meeting aimed to promote innovation in biomedical technology, accelerate research and development, and enhance the quality and safety of clinical applications [3] - It emphasized the need to balance development and safety, ensuring that clinical research is conducted in a regulated manner to mitigate risks and improve public health outcomes [3]
国常会最新部署!
第一财经· 2025-09-12 14:00
Group 1 - The meeting emphasized the importance of enhancing flood prevention and disaster relief capabilities in northern regions, particularly in light of the recent flood and typhoon risks, and called for comprehensive improvements in infrastructure and emergency response systems [1] - The government aims to promote private investment by addressing key concerns of enterprises, expanding access, and implementing practical measures to support investment in new production capacities, emerging services, and new infrastructure [2] - There is a focus on improving the overseas comprehensive service system to support companies in international cooperation and competition, including the establishment of service platforms and overseas service stations in key countries [2] Group 2 - The meeting highlighted the need to accelerate innovation in biomedical technology, ensuring the quality and safety of clinical research while promoting the transformation and application of research outcomes to enhance the biopharmaceutical industry [2]
重磅发布!国常会,最新部署!
券商中国· 2025-09-12 13:52
Core Viewpoint - The article discusses the Chinese government's initiatives to enhance private investment, improve overseas service systems, and promote biomedical technology innovation, aiming to stimulate economic growth and competitiveness in international markets [1][2][3]. Group 1: Promotion of Private Investment - The government aims to expand the space for private investment by supporting investments in new productive forces, emerging service industries, and new infrastructure [3]. - Measures include ensuring fair competition, removing hidden barriers to private investment, and enhancing innovation and financing support for private enterprises [3]. - Private investment accounts for over half of total investment in China, making it a crucial component for effective investment expansion and economic stability [3]. Group 2: Overseas Comprehensive Service System - The government is focused on improving the overseas comprehensive service system to support Chinese enterprises in international cooperation and competition [2][5]. - This includes integrating legal, financial, and logistical services to create a robust service platform for businesses venturing abroad [5][6]. - Recent initiatives, such as the establishment of comprehensive service platforms in regions like Zhejiang, aim to address challenges faced by enterprises in the overseas investment process [6]. Group 3: Biomedical Technology Innovation - The government emphasizes the need to accelerate the research and application of biomedical technologies to enhance the quality and competitiveness of the biopharmaceutical industry [2]. - The focus is on fostering innovation and transforming research outcomes into practical applications, thereby creating new advantages for development [2].