【新华解读】规范生物医学新技术应用 助力健康中国建设

Core Points - The State Council's executive meeting approved the draft regulation for the management of clinical research and application of new biomedical technologies, aiming to promote innovation and accelerate the transformation of research outcomes in the biomedical industry [1] - The regulation emphasizes the dual focus on development and safety, ensuring the quality and safety of clinical applications while effectively preventing various risks [1] - The establishment of this regulation is seen as a significant step towards modernizing the governance system and capabilities in the biomedical field, facilitating the integration of research and application, and clarifying responsibilities among research institutions, enterprises, and medical organizations [1] Industry Summary - The biomedical technology sector is recognized as one of the fastest-growing and most challenging areas within the life sciences, providing new means for disease diagnosis and treatment while also posing risks related to privacy, biosecurity, public safety, and social ethics [1] - The regulation aims to enhance the quality and safety of medical practices, safeguard human dignity and health, and promote medical advancements through standardized clinical research and application processes [1] - By addressing the barriers between research and application, the regulation is expected to expedite the availability of cutting-edge biomedical technologies to the public, while also reinforcing risk warning and emergency management mechanisms [1]