生物医学新技术迎新规：法治化护航产业高质量发展

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].