生物医学新技术新规出台，明确"安全与发展并重"

Core Points - The Chinese government is enhancing the regulatory framework for biomedical new technology clinical research to ensure scientific validity and risk control, with the new regulations set to take effect on May 1, 2026 [1][2] - The regulations emphasize the need for ethical considerations and the protection of patient rights during clinical research, addressing challenges such as ethical disputes and the unclear path from research to clinical application [2][3] Regulatory Framework - The newly published regulations define biomedical new technology as methods and measures that have not yet been applied clinically within China, aimed at health assessment, disease prevention, and treatment [1] - The regulations require that clinical research and application of biomedical new technologies must balance development and safety, with the national health department overseeing the supervision [2][3] Institutional Requirements - Institutions conducting clinical research must meet five key conditions, including being a tertiary hospital, having appropriate ethical committees, and ensuring adequate funding and research capabilities [3][4] - Clinical research institutions are responsible for ensuring the scientific and ethical integrity of their studies, with specific legal responsibilities outlined in the regulations [4][5] Penalties and Compliance - The regulations establish penalties for violations, including fines and potential bans on conducting clinical research for serious infractions [5][6] - Institutions must ensure informed consent from participants, protect personal information, and provide treatment for any health damages caused during the research [6][7] Insurance and Patient Protection - The regulations encourage clinical research institutions to purchase commercial insurance to provide additional protection for participants, promoting a harmonious doctor-patient relationship [7]