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Take home:
- CFDA released the revised Clinical Trial Quality Management Standard for Foods for Special Medical Purpose, which further clarifies the technical capacity requirements for intuitions undertaking clinical trial efficacy testing requirements. Testing agencies should have an individual nutrition department and/or an accreditation department to fit FSMP clinical trial requirements.
On November 1, 2016, CFDA released the final version of Clinical Trial Quality Management Standard for Foods for Special Medical Purpose (hereafter called the Standard) which will come into effect immediately.
In general, there is no big change compared to the exposure draft released on 15th April except that the revised standard clarifies that institutions conducting clinical trials should have a nutrition department and samples submitted for clinical trial should be tested by certified food testing institutions.
In China, nutrition research is relatively underdeveloped and not all drug clinical trial institutions have a nutrition department. The endpoints of FSMP clinical trials differ from drug clinical trials in many ways and this is reflected in the new requirement for institutions with specialized technical capacities. The Standard demands that FSMP clinical trial research should also be conducted with the support of a dietician or qualified person with relevant academic/professional background.
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