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 New Biomedical Technologies" will take effect on May 1, 2026, aiming to enhance the management of biomedical technology research and application in China [1] Group 1: Background and Purpose - Biomedical technology has significant potential in disease prevention, diagnosis, and treatment, driving medical progress and health development [2] - The regulations aim to improve the management system for clinical research and application of new biomedical technologies, ensuring safety and quality in medical practices [2] Group 2: Overall Approach - The regulations focus on prioritizing public health, risk prevention, and safety assurance while promoting innovation in biomedical technology [3] - Responsibilities of clinical research institutions and sponsors are clearly defined to ensure accountability [3] Group 3: Scope of Application - The regulations apply to clinical research and translation applications of biomedical technologies within China, defining biomedical technologies as those that operate at the cellular and molecular levels [4] Group 4: Regulations on Clinical Research - Clinical research can only commence after non-clinical studies prove safety and efficacy, and after ethical reviews [5] - Clinical research institutions must adhere to approved research protocols and conduct follow-up monitoring of participants [5] Group 5: Support for Clinical Translation Applications - The regulations establish conditions and procedures for the clinical translation of biomedical technologies, requiring approval from health authorities [6][7] - Quality and safety of clinical applications are emphasized, with specific requirements for medical institutions and personnel [6] Group 6: Protection of Participants' Rights - The regulations outline the protection of participants' rights, including obtaining informed consent and ensuring no fees are charged for participation [8] - Institutions are encouraged to provide insurance for participants and protect their personal information [8] Group 7: Implementation Measures - The National Health Commission will enhance awareness and understanding of the regulations through training and outreach [9] - Development of supporting systems and personnel training is essential for effective implementation of the regulations [9]