Newsletter summary
[the General Administration of Market Supervision revises and issues the "quality Management Standard for Clinical Trials of Formula Foods for Special Medical uses") Securities Times e Company NewsDragontigergateenglishThe General Administration of Market Supervision recently revised and issued the Code for quality Management of Clinical Trials of Formula Foods for Special Medical uses (hereinafter referred to as "the Standard"). RevisionDragontigergateenglish.Dragontigergateenglish..
Text of news flash
[the General Administration of Market Supervision revises and issues the quality Management Standards for Clinical Trials of Formula Foods for Special Medical uses ") the General Administration of Market Supervision recently revised and issued the" quality Management Standards for Clinical Trials of Formula Foods for Special Medical uses "(hereinafter referred to as" norms "). Optimization of the revised CodeDragontigergateenglishThe relevant requirements of clinical trial scheme design were discussed. Combined with the actual development of clinical trials and the current situation of industrial development, the specific quantitative requirements for the number of subjects and the trial cycle are no longer required, but adjusted according to different disease types and trial designs. "sample size" and "trial cycle" are determined on the basis of meeting the statistical requirements. Strengthen the relevant contents of the protection of the rights and interests of the subjects. Fully draw lessons from the internationally accepted guiding principles, emphasize the main responsibilities of applicants, ethics committees, researchers, inspectors and clinical trial institutions, and clarify the quality management requirements of subjects in the process of clinical trials, such as the demands of subjects and the protection of subjects' rights and interests, so as to ensure the rights and safety of subjects. It highlights the actual clinical use of special medicine food. Add contents that can highlight the characteristics of special food formula, nutrition and applicable population in the relevant chapters such as clinical trial programs and reports, and pay attention to the actual clinical application of the products. to provide more targeted reference for product research and development and quality control of clinical trials.