Recently, China's State Administration for Market Regulation (SAMR) revised and issued the "Code of Practice for the Quality Management of Clinical Trials of Food for Special Medical Purposes" (hereinafter referred to as the "Code").

The revised Code has adjusted the overall framework in accordance with the order of conducting clinical trials. From the original 11 chapters, 54 adjusted to 8 chapters, 55, retained the general provisions, duty requirements, clinical trial protocols, data management and statistical analysis, clinical trial reports, bylaws, six chapters, increased the implementation of clinical trials, terms and definitions of the two chapters, to facilitate the implementation of the operation, and to further refine and clarify the specific responsibilities of each party involved.

The Code optimizes the requirements related to clinical trial protocol design. Combined with the actual conduct of clinical trials and the status quo of industrial development, the number of subjects and the trial period is no longer a specific number of requirements, adjusted to different types of diseases and trial design, to meet the statistical requirements based on the determination of the "sample size" and "trial period". The specification has strengthened the requirements for subjects.

The Code has strengthened the protection of subjects' rights and interests. Drawing on internationally accepted guidelines, the Code emphasizes the responsibilities of the applicant, the ethics committee, the investigator, the supervisor and the clinical trial organization, and specifies the quality management requirements of each subject in the process of clinical trials, such as the claims of subjects and the protection of subjects' rights and interests, so as to ensure the rights and interests and safety of the subjects.

The Code highlights the actual clinical use of special medical food. In the clinical trial program and report and other relevant chapters to increase can highlight the characteristics of special food formulations and nutritional characteristics, the characteristics of the applicable population, focusing on the actual clinical application of the product, for product development and quality control of clinical trials to provide a more targeted reference.