Core Points - The State Council of China has issued the "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies," effective from May 1, 2026, aimed at standardizing clinical research and promoting innovation in medical science [1][2]. Group 1: Overall Requirements - The regulations emphasize a health-centered approach, innovation-driven development, and a balance between development and safety, encouraging clinical research while enhancing safety management throughout the process [1]. Group 2: Clinical Research Regulation - Biomedical new technologies must demonstrate safety and efficacy through non-clinical research and undergo academic and ethical reviews before clinical research can commence. Clinical research must be filed with the National Health Commission, which will evaluate and address risks [1][2]. - The rights of participants in clinical research are protected, prohibiting any fees from being charged to participants and ensuring timely treatment for any health damages incurred [1]. Group 3: Support for Translation Applications - Biomedical technologies that are proven safe and effective can be translated into clinical applications upon approval from the National Health Commission, which will also publish the conditions for medical institutions and professionals involved [2]. - The National Health Commission is responsible for re-evaluating the clinical applications of biomedical technologies based on scientific advancements, prohibiting applications that cannot ensure safety and efficacy [2]. Group 4: Legal Responsibilities - The regulations impose strict legal responsibilities for violations in the clinical research and translation application processes of biomedical technologies [3].

Core Viewpoint - The introduction of the "Regulations on the Management of Clinical Research and Clinical Application of Biomedical New Technologies (Draft)" marks a new era of legal regulation for China's biomedical industry, providing systematic institutional support for high-quality development [1][2]. Summary by Relevant Sections Regulatory Framework - The draft regulations aim to standardize clinical research and application of biomedical technologies, addressing challenges such as privacy breaches, biological safety risks, and ethical controversies [1][2]. - The regulations categorize biomedical new technologies as those that have completed preclinical research and are intended for disease diagnosis, prevention, treatment, and health improvement [2]. Approval Process - The draft specifies a two-tier management system based on risk levels, with provincial authorities required to complete reviews for medium and low-risk technologies within 60 days, significantly enhancing approval efficiency [3]. - High-risk projects will undergo national-level approval, ensuring a clear path for cutting-edge technologies like cell and gene therapy [3][4]. Innovation and Collaboration - The regulations are expected to foster cross-disciplinary collaboration, promoting integration between medicine and engineering, and enhancing the pace of technological innovation and results transfer [4]. - By aligning with international standards, the regulatory framework aims to improve the global competitiveness of China's biomedical industry [4]. Ethical and Safety Considerations - The draft emphasizes the importance of ethical reviews and requires that clinical applications pass academic and ethical assessments, ensuring safety and compliance with informed consent protocols [4][5]. - Transparency in the approval process is mandated, enhancing public trust and regulatory credibility [4]. Implementation Challenges - Potential challenges include uneven regulatory resources across regions, difficulties in establishing unified standards, and the need for clear qualifications for clinical research personnel [5][6]. - To ensure effective implementation, the industry must focus on internal quality control, external oversight, and robust technical support systems [6][7].

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 [2][3] - It was noted that extreme rainfall has caused significant damage in some regions, necessitating a coordinated response from local authorities and departments to ensure the safety and recovery of affected populations [2][3] 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 [3] - Specific strategies include expanding access for private investment, enhancing support for new productivity sectors, emerging services, and new infrastructure projects, as well as ensuring fair competition in the market [3] Group 3: Overseas Comprehensive Service System - The meeting discussed the need to strengthen the overseas comprehensive service system to support domestic enterprises in international cooperation and competition [3] - This includes improving coordination across legal, financial, and logistical services, and establishing service platforms to assist companies venturing abroad [3] Group 4: Biomedical Technology Regulation - The meeting approved a draft regulation aimed at managing clinical research and the application of new biomedical technologies, focusing on innovation and safety [4] - The goal is to enhance the quality and safety of clinical applications while effectively mitigating various risks associated with biomedical innovations [4]