李强签署国务院令

Core Viewpoint - The article discusses the newly published "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies," which aims to standardize clinical research and application of biomedical technologies, promote medical innovation, ensure medical quality and safety, and protect human dignity and health [2][5]. Group 1: Overall Requirements - The regulations emphasize a people-centered approach to health, innovation-driven development, and a balance between development and safety, encouraging clinical research and application while strengthening safety management throughout the process [2][9][10]. 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 Department, which will evaluate and correct risks as necessary [2][18][28]. - The rights of participants must be protected, ensuring that no fees are charged to participants and that any health damages are promptly treated [2][11][35]. Group 3: Support for Translation Applications - 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 [3][42][44]. - The National Health Department is required to re-evaluate technologies based on scientific advancements, prohibiting clinical applications if safety and efficacy cannot be assured [3][47]. Group 4: Legal Responsibilities - The regulations impose strict legal responsibilities for violations in clinical research and application, including penalties for unauthorized practices and the requirement to cease operations in case of serious violations [4][53][54].