On Oct. 11th, 2019, SAMR [1] finally released the official version of FSMP (food for special medical purposes) clinical technique guidelines which are.
"Clinical Technique Guidelines of Special Medical Purpose (Diabetes Disease) Full Nutrition Formulas"
"Clinical Technique Guidelines of Special Medical Purpose (Kidney Disease) Full Nutrition Formulas"
"Clinical Technique Guidelines of Special Medical Purpose (Tumor Disease) Full Nutrition Formulas"
Earlier in June this year, SAMR published the three consultation drafts which were open for public feedback until July 15th, 2019. In comparison to the 3 draft regulations, the final versions released on October 11th entail one major change as shown below:
An exclusion criterion was added in the selection of subjects (the participants in clinical test), that is, subjects who participate in other interventional clinical trials (including drugs, nutritional preparations, medical devices, etc.) within 4 weeks shall be screened/filtered out.
Except for this major change, the rest of the content in the final versions are basically the same as the draft version. To acquire more information about the guidelines, please click here.
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