SAMR issues guidelines for clinical trials of nutritional formulas for medical purposes
China
Jun 02, 2025
The State Administration of Market Regulation (SAMR) announces the publication of 2 technical guidance documents on “Technical Guidelines for Clinical Trials of Targeted Complete Nutritional Formula Foods - Liver Disease” and “Technical Guidelines for Clinical Trials of Targeted Complete Nutritional Formula Foods - Gastrointestinal Absorption Disorders”. These Guidelines aim to guide clinical trial companies and institutions to standardize the clinical trial process for the corresponding categories of specific complete nutritional formula foods, ensure that the data and results are scientific, authentic and reliable, improve the efficiency of registration review and approval, protect the safety and rights of consumers, and ensure product safety, nutritional adequacy and clinical efficacy.
For further information (in Chinese), click on the Link
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