规范生物医学新技术应用 助力健康中国建设

Core Viewpoint - The State Council's executive meeting approved the draft regulation for the management of clinical research and clinical application of new biomedical technologies, aiming to promote innovation and development in China's biomedical technology sector while ensuring safety and quality in clinical applications [1] Group 1: Regulation and Development - The regulation aims to accelerate the research and application of biomedical technologies, enhancing the quality and upgrading the biomedical industry [1] - Biomedical technology is recognized as one of the fastest-growing and most challenging fields, providing new means for disease diagnosis and treatment while posing risks related to privacy, biosecurity, public safety, and social ethics if mismanaged [1] Group 2: Safety and Quality Assurance - The meeting emphasized the importance of balancing development and safety, advocating for legal regulation of clinical research to ensure quality and safety in clinical applications [1] - The regulation is expected to clarify responsibilities among research institutions, enterprises, and medical organizations, strengthening risk warning and emergency management [1] Group 3: Impact on the Industry - The establishment of the regulation is seen as a significant step towards modernizing the governance system and capabilities in the biomedical field, facilitating the translation of cutting-edge biomedical technologies to benefit the public [1]