China’s State Administration of Market Regulation released 3 Technical Rules for Clinical Trials of Specific Whole Nutrition Food for Special Medical Purpose (FSMP) on 2019/10/11. These Rules are made to standardize the clinical processes and criterion of evaluating a submitted Specific Whole Nutrition FSMP .
The released 3 Rules are for Diabetes, Nephropathy and Tumor.
China FSMP falls into 3 categories:
1. Whole Nutrition FSMP – can be used as the only nutrients source to cover the nutrition needs of the target group
2. Specific Whole Nutrition FSMP – can be used as the only nutrients source to cover the nutrition needs of the target group under certain diseases or medical conditions.
3. Non-Whole Nutrition FSMP – can be used as part of the nutrients source of the target group. It can’t be taken as the only nutrients source.
These technical rules shall apply to the second category. (Source: HPA-China)