生物医学新技术新规出台，明确“安全与发展并重”

Core Viewpoint - China is advancing in the field of biomedical new technologies, necessitating a regulatory framework to ensure the scientific validity and risk control of clinical research [1][2] Regulatory Framework - The State Council has issued the "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies," effective from May 1, 2026 [1] - The regulations define biomedical new technologies as medical methods and measures that have not yet been applied clinically within China, aimed at health assessment, disease prevention, and treatment [1] Challenges in Biomedical Innovation - The rapid pace of medical innovation often outstrips the development of regulatory systems, leading to ethical controversies and technical risks that may provoke social skepticism [2] - There are challenges in translating some research outcomes into tangible benefits for patients, with unclear pathways from research to clinical application [2] Management and Oversight - The regulations emphasize a dual focus on development and safety, with the National Health Commission responsible for overseeing clinical research and applications [2] - Institutions conducting clinical research must meet specific qualifications, including being a tertiary hospital and having appropriate ethical review boards and research capabilities [3][4] Responsibilities and Penalties - Clinical research institutions bear primary responsibility for ensuring the scientific and ethical integrity of their studies [4] - The regulations outline penalties for violations, including fines and potential bans on conducting clinical research for serious infractions [5][6] Protection of Participants - The regulations stress the importance of informed consent, requiring clear communication of risks and benefits to participants [6][7] - Institutions are mandated to provide timely treatment for any health damages caused during research, with costs covered by the initiating organization [7][8]