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药品医疗器械监管改革
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国家药监局药品和医疗器械审评检查京津冀分中心、华中分中心、西南分中心挂牌成立
Xin Lang Cai Jing· 2025-09-24 10:45
9月21日至24日,国家药监局分别在北京市、湖北省武汉市、重庆市举行药品和医疗器械审评检查京津 冀分中心、华中分中心、西南分中心挂牌仪式。国家药监局党组书记、局长李利一行参加挂牌仪式并调 研当地医药产业发展、分中心筹建等情况。李利指出,设立国家药监局药品和医疗器械审评检查京津冀 分中心、华中分中心、西南分中心,是进一步服务京津冀协同发展、中部地区崛起、新时代推动西部大 开发等区域发展重大战略,纵深推进药品医疗器械监管改革,促进医药产业高质量发展的重要举措。国 家药监局将与北京市、湖北省、重庆市同心同向、共商共建,全面落实合作协议,推动分中心全面履 职、高效运转。 ...
山西出台药品医疗器械监管改革新规 28项举措促发展
Zhong Guo Xin Wen Wang· 2025-06-13 01:11
Core Viewpoint - Shanxi Province is implementing a series of 28 specific measures to enhance the regulation and development of the pharmaceutical and medical device industry, aiming for high-quality growth in the sector [1][2]. Group 1: Support for R&D Innovation - The measures emphasize strengthening key core technology breakthroughs, accelerating the transition of drug research to clinical trials, encouraging the development and industrialization of innovative drugs and devices, promoting traditional Chinese medicine innovation, enhancing standard leadership, and strengthening intellectual property protection [1]. Group 2: Improvement of Review and Approval Efficiency - The measures include optimizing the review and approval mechanisms, expediting the approval of urgently needed drugs and medical devices, improving clinical trial review processes, enhancing service efficiency in approvals, optimizing registration inspections, accelerating the review of drugs and devices for rare diseases, and advancing the implementation of internationally accepted regulatory rules [2]. Group 3: Promotion of Innovative Product Application - The measures encourage enterprises to increase the application of innovative results, expedite the use of innovative drugs and medical devices in hospitals, enhance medical insurance payments, and optimize import and export support [2]. Group 4: Enhancing Compliance through Effective Regulation - The measures stress the importance of strict regulatory responsibilities, integrating regulation with service, and ensuring high-level safety to support high-quality development, including promoting the authorization of biological product batch release and improving the quality of generic drugs [2]. Group 5: Building a Regulatory System Aligned with Industry Needs - The measures propose to improve the drug safety responsibility system, enhance regulatory capacity building, strengthen regulatory scientific research, and advance regulatory information technology construction [2]. Implementation Timeline - The measures will take effect on June 16, with a commitment to deepen pharmaceutical regulation reforms and support high-quality development in the industry [2].