In order to improve FSMP registration management, guide the clinical trials research and standardize the clinical trials process of specific full nutrition FSMP, ensure the scientificity and reliability of clinical trials results, protect the safe rights of consumers, the SAMR plans to public solicitate the research institutes on the technical guidelines for clinical trials of specific full nutrition FSMP. The notice is as follows:
1.The projects information
The technical guidelines for clinical trials of specific full nutrition FSMP for 8 diseases types including respiratory disease will be organized.
2.Requirements for applicants
The applicant shall be a drug clinical trial institution in the relevant field with the nutrition department and professional department related to FSMP studied and meet the conditions to carry out clinical trials research on FSMP, also has the preliminary scientific basis and relevant research work experience that could provide corresponding guarantee conditions to ensure to complete the drafting of technical guidelines timely and quality.
3.The application method and deadline
Please fill in the application form of the technical guidelines for clinical trials of specific full nutrition FSMP according to the requirements, and send the paper version (sealed, in triplicate) and the electronic version to the special food division of the SAMR before
Press release: link