李强签署国务院令，公布《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 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 trials can commence. Clinical research must be filed with the National Health Commission, which will evaluate and address risks [1] - The rights of participants in clinical research are prioritized, 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 technologies that are proven safe and effective can be translated into clinical applications upon approval from the National Health Commission, which will also publish the necessary conditions for medical institutions and professionals involved [2] - The regulations include strict legal responsibilities for any violations in the clinical research and application processes [2]