李强签署国务院令

Core Viewpoint - The newly published "Regulations on the Management of Clinical Research and Clinical Translation Application of Biomedical New Technologies" aims to standardize clinical research and application of biomedical technologies, promote medical science and technology innovation, ensure medical quality and safety, and protect human dignity and health. The regulations will take effect on May 1, 2026 [1][4]. Group 1: Overall Requirements - The regulations emphasize a people-centered approach to health, innovation-driven development, and a balance between development and safety. They encourage and support clinical research while strengthening safety management throughout the process [1][5]. Group 2: Clinical Research Regulation - Biomedical new technologies must be proven safe and effective through non-clinical research and undergo academic and ethical reviews before clinical research can commence. Clinical research must be filed with the National Health Department, which will evaluate and correct any identified risks [2][8]. - The rights of participants must be protected, and no fees can be charged to participants. Any health damage caused to participants must be treated promptly [2][18]. Group 3: Support for Translation Application - Technologies proven safe and effective through clinical research can be applied clinically upon approval from the National Health Department, which will also publish the conditions for medical institutions and professionals involved [2][23]. - The National Health Department will re-evaluate the technologies based on scientific developments, and if safety and effectiveness cannot be guaranteed, clinical application will be prohibited [2][25]. Group 4: Legal Responsibilities - Strict legal responsibilities are outlined for violations of the regulations, including penalties for conducting prohibited clinical research or applying unapproved technologies [2][34].