李强签署国务院令 推动我国生物医学技术创新发展

Core Points - The State Council of China has issued the "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies," effective from May 1, 2026, aimed at standardizing clinical research and promoting innovation in medical science [1][2]. Group 1: Overall Requirements - The regulations emphasize a health-centered approach, innovation-driven development, and a balance between development and safety, encouraging clinical research while enhancing safety management throughout the process [1]. Group 2: Clinical Research Regulation - Biomedical new technologies must demonstrate safety and efficacy through non-clinical research and undergo academic and ethical reviews before clinical research can commence. Clinical research must be filed with the National Health Commission, which will evaluate and address risks [1][2]. - The rights of participants in clinical research are protected, prohibiting any fees from being charged to participants and ensuring timely treatment for any health damages incurred [1]. Group 3: Support for Translation Applications - Biomedical new technologies that are proven safe and effective can be applied clinically upon approval from the National Health Commission, which will also publish the conditions for medical institutions and professionals involved [2]. - The National Health Commission is responsible for re-evaluating the clinical application of biomedical new technologies based on scientific advancements, prohibiting applications that cannot ensure safety and efficacy [2]. Group 4: Legal Responsibilities - The regulations impose strict legal responsibilities for violations occurring during clinical research and clinical translation applications of biomedical new technologies [3].