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 the clinical research and application of new biomedical technologies, promoting medical science and technology innovation while ensuring safety and ethical standards [2][3] - The regulation defines new biomedical technologies as methods and measures that have not yet been applied clinically in China, aimed at assessing health status or preventing and treating diseases [2][4] - The regulation emphasizes a people-centered approach, encouraging innovation while balancing development and safety [2][4] Chapter Summaries General Principles - The regulation is applicable to all biomedical technology clinical research and applications within the territory of the People's Republic of China [2] - It mandates that all research must have scientific backing, comply with laws and regulations, and prioritize the health and rights of participants [2][4] Clinical Research Filing - Clinical research must be preceded by laboratory and animal studies to ensure safety and efficacy before human trials can commence [4][5] - Institutions initiating clinical research must be legally established entities within China and ensure that the technology has been proven safe and effective through non-clinical studies [5][6] Implementation of Clinical Research - Clinical research must be conducted according to the approved research plan, and any changes must be reported to the health department [11][12] - Institutions must obtain informed consent from participants, ensuring they understand the research's purpose and potential risks [19][21] Clinical Application - After successful clinical research, the application of new biomedical technologies in clinical settings requires approval from the health department [29][30] - The health department will prioritize applications for technologies addressing severe diseases or public health emergencies [32][33] Supervision and Management - Local health departments are responsible for supervising and inspecting clinical research and applications, with the authority to impose penalties for violations [39][40] - An online service system will be established to facilitate the filing and reporting processes for research institutions [42][43] Legal Responsibilities - Violations of the regulation can result in significant fines and penalties, including the suspension of research activities and revocation of licenses for responsible personnel [23][24][25] - Institutions must ensure the accuracy and completeness of all submitted materials and reports [10][11] Miscellaneous - The regulation will come into effect on May 1, 2026, allowing existing research to continue under the new framework [31][32]