These guidelines aim to provide guidance for the design, implementation and evaluation of clinical trials of full nutrition formula foods for diabetes for special medical purposes. The text mainly include the purpose of clinical trials, the selection of subjects, the requirements of test samples, the design of test scheme, the observation indexes, the determination of results, data management and statistical analysis, etc. The applicant for registration of formula foods for diabetes for special medical purposes is not required to enforce the guidelines. If the applicant puts forward the experimental design beyond the guidlines according to the product formula, nutritional characteristics, clinical effect and preliminary research basis of the application for registration of full nutrition formula food for special medical purpose diabetes, and can have sufficient scientific basis to explain its scientificity and rationality, the clinical trial can also be carried out and recognized.
中国 · 2019-09-27