规范生物医学新技术研发应用？ 两部门解读《生物医学新技术临床研究和临床转化应用管理条例》

Core Viewpoint - The "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies" will take effect on May 1, 2026, aiming to enhance the management and safety of biomedical technology applications in clinical settings [1] Background of the Regulations - Biomedical technology has significant potential in disease prevention, diagnosis, and treatment, driving medical progress and public health development [2] - The government has increased policy support for biomedical technology innovation, necessitating a regulatory framework to ensure safety and quality in clinical applications [2] Overall Approach - The regulations focus on prioritizing public health, supporting clinical research and translation applications, and clarifying the responsibilities of research institutions [3] Scope of Application - The regulations apply to all biomedical new technology clinical research and translation applications conducted within China, defining biomedical new technologies as those that operate at the cellular and molecular levels [4] Regulations on Clinical Research - Clinical research must demonstrate safety and efficacy through non-clinical studies and ethical reviews before proceeding [5] - A registration management system for clinical research is established, requiring evaluations by health authorities to identify and mitigate risks [5] - Clinical research institutions must follow approved research protocols and monitor long-term safety and efficacy post-research [5] Support for Clinical Translation Applications - The regulations outline conditions and procedures for the clinical translation of biomedical technologies, requiring approval from health authorities [6] - Quality and safety standards for clinical applications are mandated, including the qualifications of medical institutions and personnel [6] - Continuous re-evaluation of biomedical technologies is required to ensure ongoing safety and efficacy [6] Protection of Participants' Rights - The regulations emphasize the protection of participants' rights, requiring informed consent and prohibiting fees related to clinical research [7][8] - Institutions must provide timely treatment for any health damages caused during research and ensure the confidentiality of participants' personal information [8] Implementation Measures - The health authorities will enhance public awareness and understanding of the regulations through training and outreach [9] - There will be a focus on developing supporting systems and improving regulatory capabilities to ensure effective implementation [9]