Core Viewpoint - The article discusses the implementation of the "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies," which will take effect on May 1, 2026. The regulations aim to standardize clinical research and application of biomedical technologies, emphasizing scientific, safety, and ethical considerations while establishing a comprehensive regulatory framework [1][8]. Group 1: Regulatory Framework - The regulations define biomedical new technologies as medical methods that act on the cellular and molecular levels and have not yet been applied clinically within the country. A tiered management system is established, with lower-risk research managed by provincial health departments and high-risk research directly supervised by the State Council's health department [3][12]. - The regulations address the previous regulatory gaps by implementing a full-process management approach, including filing systems, ethical reviews, and re-evaluations, to ensure that technological advancements do not outpace regulatory measures [3][4]. Group 2: Balancing Innovation and Safety - The regulations require that new technologies must demonstrate safety and efficacy through non-clinical research before proceeding to clinical studies. Additionally, the translation of these technologies into clinical applications requires approval from the State Council's health department, which will also publish operational standards [4][5]. - Continuous re-evaluation of already translated technologies is mandated to ensure that risks remain manageable [4]. Group 3: Accelerating Application of Results - The regulations clarify approval processes and timelines for clinical translation applications, including prohibiting charges to participants and ensuring compensation for damages, thereby protecting participant rights and facilitating the implementation of technologies [5][6]. - The National Health Commission will develop supporting implementation details to promote technology research and industrial upgrades [5]. Group 4: Legal Responsibilities - Strict legal responsibilities are established for violations, including halting high-risk research and prohibiting the clinical application of ineffective technologies. This legal framework aims to safeguard medical quality and public interest [7][8]. - The regulations will mark a shift towards a more standardized and legally governed development phase for biomedical technologies in China [8].