SAMR issued clinical trial guidelines (draft) for 3 specific nutritionally complete food which are applied for patients of 3 diseases/medical conditions: diabetes, cancer and nephropathy, on June 14, 2019 for public comments. The deadline for the comments is July 15, 2019.
In China, FSMP (for the population over 1 year old) are classified as: nutritionally complete food, specific nutritionally complete food and nutritionally incomplete food. The clinical trials are obligatory for specific nutritionally complete food that is applied for 13 diseases/medical conditions. In 2016, the former CFDA issued the Standard of Clinical Trial Quality Management on Food for Special Medical Purposes (trial), which can be regarded as the general rules for clinical trials, while the 3 drafts issued this time, are more detailed and more targeted. For instance, the clinical effect monitoring indexes for diabetes products include: the area under the blood glucose curve within 2 or 3 hours after the test sample is consumed, and insulin resistance index (HOMA index), etc.
Therefore, there are totally 6 standards for specific nutritionally complete food in China (including 3 GBs for cancer, diabetes and IBD products, click here for detailed info), yet none of them has been come into force until now.