受权发布|生物医学新技术临床研究和临床转化应用管理条例

Core Points - The regulation aims to standardize clinical research and application of new biomedical technologies, promoting medical science and ensuring safety and ethical standards [1][2] - The regulation emphasizes the importance of prioritizing public health, innovation, and safety in the development and application of biomedical technologies [1][2] Group 1: General Principles - The regulation defines biomedical new technologies as methods and measures that have not yet been applied clinically in China, aimed at assessing health status or treating diseases [1] - It mandates that all clinical research must be based on scientific evidence and comply with legal and ethical standards [1][2] Group 2: Supervision and Management - The State Council's health department is responsible for overseeing the clinical research and application of biomedical technologies at the national level [2] - Local health departments are tasked with managing and supervising these activities within their jurisdictions [2] Group 3: Clinical Research Registration - Institutions must conduct non-clinical research to prove the safety and efficacy of new technologies before initiating clinical trials [3][4] - Clinical research institutions must meet specific criteria, including being a tertiary hospital and having the necessary ethical and academic committees [4][5] Group 4: Implementation of Clinical Research - Clinical research must be conducted according to approved protocols, and any changes must be reported to the health department [7][8] - Informed consent from participants is mandatory, and institutions cannot charge participants for research-related costs [19][20] Group 5: Clinical Application - After successful clinical research, the application of biomedical technologies requires approval from the health department [29][30] - The health department will prioritize applications for technologies addressing severe diseases or public health emergencies [32] Group 6: Legal Responsibilities - Violations of the regulation can result in significant fines and penalties, including the suspension of clinical research activities [43][44] - Institutions providing false information during the application process may face severe consequences, including the revocation of licenses [51][52]